Dogs

Clinical trials for dogs

  • Description

    The goal of this study is to determine if TK isoenzymes are good biomarkers for the early detection of HSA in dogs and to identify a threshold for detecting HSA from the presence of TK isoenzymes.

    HSA is a malignant and rapidly growing cancer that is difficult to detect. HSA is a tumor derived from blood vessels, and thus the tumor is filled with blood. A frequent cause of death from HSA is the rupturing of the tumor, causing the patient to rapidly hemorrhage to death. HSA is common in dogs, and more so in certain breeds of dogs such as German Shepherds and Golden Retrievers. Dogs with HSA rarely show clinical signs until the tumor has become very large and has metastasized. Typically, clinical signs are due to hypovolemia after the tumor ruptures, causing severe bleeding. Owners of the affected dogs often discover that the dog has HSA only after the animal has collapsed secondary to bleeding. The HSA tumor often appears on the spleen, right side of the heart or liver.

    There are currently no commercially viable screening mechanisms for detecting HSA in dogs. Most dogs present with HSA as emergencies and major decisions about treatment must be made without a definitive diagnosis. A screening test that would allow the detection of HSA would be very valuable in the planning of treatment and earlier detection of the disease. Preliminary data in dogs suggests that TK is significantly increased in dogs with some types of cancer, specifically HSA and thus TK may be useful in detecting, staging and monitoring disease in dogs with HSA.

    Inclusion Criteria

    Any dog (any age, sex or breed) with a hemoabdomen that undergoes exploratory surgery.

    Exclusion Criteria

    Dogs with pre-existing, previously diagnosed neoplastic conditions other than hemangiosarcoma will be excluded.

    Client Benefits

    There are no direct benefits to the client. The indirect benefit is that this research will aid in the development of a point-of-care test for the diagnosis of hemangiosarcoma in dogs which will help owners of dogs with hemoabdomen make decisions regarding the best management for their dogs.

    Contact Information

    Dr. Claire Sharp
    Phone: (508) 839-5302

  • Description

    To evaluate the effect of plavix dosing in respect to how much time is needed to achieve maximum platelet inhibition which may decrease risk of thrombeombolic disease.

    Inclusion Criteria

    Diagnosis of protein losing nephropathy, cases with high indices of suspicion without definitive diagnosis will also be considered.

    Exclusion Criteria

    Dogs will be excluded if they have received steroids or any anticoagulant medications.

    Client Benefits

    May be able to use a lower dose of plavix, therefore, more cost-effective.

    Contact Information

    Dr. Melissa Bucknoff, DVM
    Phonoe: (508) 839-5395

  •  

    Description:

    Lymphoma is one of the most common cancers in the dog and is comparable to non-Hodgkin’s lymphoma in humans. Chemotherapy is the standard of care for treatment and can provide long term disease control but survival beyond 2 years is rare.

    There is active investigation into the utility of metabolic markers, such as insulin-like growth factor 1 (IGF-1), as a predictor of response to treatment in humans with non-Hodgkin’s lymphoma. Additionally these markers may serve as a target for future therapy.

    The goal of this study is to assess levels of IGF-1 and other related blood biomarkers in canine patients with lymphoma. We will evaluate these markers for prognostic value and will determine whether they could serve as targets for therapy in the future.

    Inclusion Criteria:

    Dogs with a confirmed diagnosis of multicentric lymphoma (cytology or pathology), weighing more than 25kg. Dogs must be eating a commercial diet and be otherwise healthy.

    Exclusion Criteria:

    Dogs with other systemic diseases (diabetes mellitus, hypothyroidism, Cushing’s disease, kidney disease, liver disease, etc). Dogs eating a home-cooked or raw diet.

    Client Benefits:

    No direct benefits. Dog owners are financially responsible for the costs associated with cancer staging plus standard chemotherapy and recommended treatment monitoring (weekly complete blood counts).

    This study covers the cost of measurement of IGF-1 and other metabolites.

    Contact Information:

    Kelly Reed, Oncology liaison at 508-887-4682 or email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

     

     

     

     

  • Description:
    OA is a progressive degenerative disease with a variety of treatment options suggesting that reliable, safe, and effective treatment has yet to be discovered. In search of treatment options, autologous (dog’s own) concentrated platelets appear to show promise as a safe alternative, free of the risks associated with some non-steroidal antiinflammatory agents. The purpose of this study is to establish more data on the emerging C-PET treatment for OA.
    Inclusion criteria:
    Dogs must have a medical history or physical findings of bilateral elbow osteoarthritis.
    Must weigh at least 25 lbs.
    Must be between 18 months and 10 years of age.
    Exclusion criteria:
    Surgery on joint within one year
    systemic steroid administration,
    joint injection with in 4 months
    Adequan injection within one month
    Client benefits:
    The study will cover cost of blood work, radiographs, and C-PET treatment for qualified animals.
    Contact information:
    Jessica Schavone
    Clinical Trials Technician
    508.839.5395 x84441
  • Description
    The objective of this study is to evaluate whether quantitative MRI assessments after acute thoracolumbar disc extrusion are predictive of long term outcome through measurement of longitudinal dispersion of extruded disc material.
    Inclusion Criteria
    Only chondrodystrophic, nonambulatory paraparetic or paraplegic dogs with or without pain perception (<48 hours), an extradural spinal cord compression at T3 – L3 diagnosed by MRI, a disc extrusion confirmed at the time of the surgery and a detailed follow-up will be included.
    Exclusion Criteria
    Dogs with concurrent disorders incompatible with long-term survival will be excluded.
    Client Benefits
    Two week, 1 month and, if needed, 2 month and 3 month post operative recheck appointments will be paid for by the study.
    Contact Information
    Dr. Tracy Sutton Phone: (508) 887-4696
  • Description

    We have started a new study to evaluate the use of ultrasound as a quick and non-invasive method of measuring muscle mass in dogs.  In many of the common diseases of dogs, such as heart failure, kidney disease, and cancer, a big problem that occurs is muscle loss.  This muscle loss is important because it can make dogs weak and can negatively affect their quality of life.  We have been studying methods of diagnosing and treating cachexia (the muscle loss that occurs with various diseases) for over 15 years. We are currently evaluating whether ultrasound, an non-invasive test, can be used to quickly and easily diagnose muscle loss in its early stages. 

    Inclusion Criteria

    To be eligible, dogs must be healthy 1-5 year old, neutered dogs (male or female) of the following breeds:

    *Chihuahua

    *Dachshund

    *Cavalier King Charles Spaniel

    *Doberman pinscher

    *Boxer

     

    Dogs must be purebred and should have no heart murmur or other medical problems. 

    Exclusion Criteria

    Dogs with heart murmurs or any significant medical conditions

    Client Benefits

    If eligible, the dog will get a free examination at Tufts, will have a small blood sample collected (less than ½ teaspoon; to measure red blood cell count, blood sugar, and an estimate of kidney function), an x-ray of the chest to measure bone size, and an ultrasound of the muscles over his or her back (no shaving required). 

     

    In addition to getting the free tests (blood test, x-ray, and ultrasound of the back muscles), this information will be beneficial in the future for dogs with heart disease, kidney disease, cancer, and other common diseases by validating an easy ultrasound test to measure muscle mass. 

    Contact Information

    Dr. Lisa Freeman Phone: (508) 887-4696

  • Protocol identification:  CSRC 004-13, approved 2/4/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:  Mary Labato, DVM, DACVIM (Small Animal Internal Medicine)
    Contact information: mary.labato@tufts.edu, (508) 839-5395, ext ext 4825
    Status of trial:  not currently enrolling

    Inclusion criteria: Dogs presenting with protein-losing nephropathy, hypoalbuminemia (<2.4 g/dl), azotemia ( creatinine > 2.5 mg/dl), thrombocytopenia ( platelets < 160,000) and hypercoagulable state; renal biopsy confirmation of diagnosis of immune complex glomerulonephritis.

    Exclusion criteria: Dogs not expected to live greater than 48 hours, those with cardiac disease, and those with neoplasia. Also excluded will be those dogs with an active bacterial urinary tract infection, and those suspected or confirmed to have leptospirosis.

    Arms/interventions:  This is a single arm open-label pilot study.  All dogs (n=6) in this study will receive a single injection of hES-MSCs intravenously once eligibility criteria are met.  Standard of care will continue throughout the trial (90 days).

    Potential direct or indirect benefits from the study (for owners and RDVM): The study will cover all of the costs that are typically accrued in the diagnostic evaluation of dogs with protein-losing nephropathy including complete blood count, chemistry profile, urinalysis, urine culture, urine protein:creatinine ratio (UPC), thromboelastograph (a clotting profile), antithrombin level (to see if your dog is a risk for forming blood clots), ANA (looking for lupus) , serology for tick borne diseases and leptospirosis. It will also cover an abdominal ultrasound examination and the cost of a kidney biopsy.  The study will also cover for follow up blood work and urinalyses during the 90 days of the study, including 2, 7, 14, 30, and 90 days after treatment.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 006-13, approved 3/25/13

    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:  Cynthia Leveille-Webster, DVM, DACVIM (SA Internal Medicine)
    Contact information:  cynthia.leveille-webster@tufts.edu, (508) 839-5395, ext 84542
    Status of trial:  not currently enrolling

    Inclusion criteria:  Labrador Retrievers with histological diagnosis of moderate to severe chronic hepatitis (based on ‘Cornell hepatic scoring system’ which grades interface hepatitis, portal inflammation and lobular apoptosis/necrosis) and a serum ALT that is at least 3 times the upper limit of normal will be enrolled.

    Exclusion criteria:  presence of infectious disease (positive cultures of the liver or bile or positive titers for Leptosporosis), exposure to known hepatotoxic medications or supplements within the last month, the presence of extrahepatic bile duct disease (revealed by diagnostic imaging), severe co-morbidity (cardiac, renal or respiratory disease, evidence of end stage hepatic failure signified by the presence of large volume ascites, serum albumin less than 1.5 g/dl or clinical scores greater than 12), a histopathologic diagnosis of cancer and the presence of thromboembolic disease (splenic or portal vein thrombosis on ultrasound).  Evidence of SIRS or shock of any origin would exclude the patients.   Patients receiving corticosteroids within the last 2 months would be excluded.

    Arms / interventions:  This is a single arm open-label pilot study.  All dogs (n=6) in this study will receive a single intravenous injection of hES-MSCs once eligibility criteria are met.  Standard of care will be maintained throughout the trial with exception that dogs will not be able to receive corticosteroids or immunosuppressive agents for the first 42 days after injection of MSCs.

    Potential direct or indirect benefits from the study (for owners and RDVM):  The study will cover some of the costs.  Owners will be reimbursed for the expenses associated with the liver biopsy (including charges for the laparoscopic surgery and the charges for the pathologist to examine the slide) IF the biopsy is supportive of the diagnosis.  All of the expenses associated with giving the injection of stem cells and in evaluating your pet after the injection will be covered.  This will include CBC and serum chemistries at 1, 3, and 6 weeks and 3 and 6 months after stem cell injections.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 030-13, approved 10/15/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:  Lluis Ferrer DVM, PhD, DECVD (Dermatology)
    Contact information:  lluis.ferrer@tufts.edu, (508) 839-5395, ext 84419
    Status of trial:  Trial is fully enrolled

    Inclusion criteria: Adult dogs (either gender, any breed) with a clinical diagnosis of anal fistulas (presence of chronic peri-anal fistula(s) with clinical signs of tenesmus, dyschezia) and history of failure to respond completely to cyclosporine A therapy.

    Exclusion criteria:   Dogs younger than 1 year or older than 10 years will be excluded; dogs with other severe diseases (severe osteoarthritis, cardiac disease, neoplasia, skin diseases) apart from anal furunculosis will be excluded.  Dogs that had surgery (cryosurgery, anal sac resection, tail amputation) to treat the anal fistulas will not be included.

    Arms/interventions:  This is a single arm open-label pilot study (n=6).  Dogs will receive hES-MSCs injected intra-lesionally (distributed evenly between fistulas) and covered by an FDA approved fibrin sealant (Evicel).  Dogs will be maintained on cyclosporine A at the same dose for the first 60 days after injection of the hES-MSCs, and then withdrawn for as long as they remain in clinical remission.

    Potential direct or indirect benefits from the study:  The study will cover all of the costs of this study including initial examination, stem cell treatment, ~$300 towards Cyclosporine treatment, and recheck examinations at 1, 2, 3, and 6 mos after injection of MSCs.

    Contact Information

    • This study is currently fully enrolled.
    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 035-13, approved 10/25/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:   Phil March, DVM, PhD, DACVN (Neurology).
    Contact information:  philip.march@tufts.edu, (508) 839-5395, ext 84953
    Status of trial:  Enrollment start date:  Jan 27, 2014. Not Currently enrolling patients

    Inclusion criteria:  A clinical diagnosis of GME based on intracranial neurologic signs that are consistent with the typical neuro-anatomical distribution of GME; corroboration of clinical findings with MRI findings of multifocal lesions in regions of white matter; CSF findings typical of GME (total white blood cell count >50 cells per µl with a predominance of lymphocytes and monocytes/ macrophages); client consent to treat with MSCs as adjunctive therapy for GME.

    Exclusion criteria:   Dogs with necrotic or grey matter predominant forms of encephalitis (e.g. necrotizing meningoencephalitis).  Evidence of infectious disease on serology, PCR, or culture; significant pre-existing concurrent systemic illness (liver, renal, cardiac, etc.) based on routine clinical and laboratory testing (complete blood count, chemistry profile, and urinalysis); positive results of patient serum on the complement lysis assay (screen for patient auto-antibodies to human cells)

    Arms / Interventions:  This is a double arm, randomized controlled open-label study of adjunct effects of hES-MSCs added to standard of care.  Dogs (n=3/group) will be randomized to receive either (1) high dose corticosteroids (tapered over 8 wks) and intravenous hES-MSCs or (2) high dose corticosteroids (tapered over 8 wks) and procarbazine for 8 weeks followed by a single intravenous injection of hES-MSCs.

    Potential direct or indirect benefits from the study: The study will cover all costs associated with administering the hES-MSC treatment, all follow up hospital visits and exams (2, 4, 6, 8, 12, 16, 20, and 24 weeks post-treatment with hES-MSCs), all costs associated with biomarker analysis, and all costs associated with the follow up MRI at 8 weeks post-hES-MSC treatment.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 038-13, approved 10/9/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigator:   Mike Kowaleski, DVM, DACVS / EVCS (Surgery)
    Contact information:  mike.kowaleski@tufts.edu, (508) 839-5395 ext 84659
    Status of trial:  Enrollment start date, Jan 27, 2014.

    Inclusion criteria:  Signalment:  15-10 kg; 10 months – 12 years of age; any gender.  Chronic, bilateral elbow osteoarthritis resulting in symptomatic forelimb lameness secondary to elbow osteoarthritis evident on clinical examination, confirmed radiographically with no clinical, hematological, or biochemical evidence of systemic disease.

    Exclusion criteria:   Systemic disease, other sources of musculoskeletal lameness (e.g. polyarthritis), reliance on daily oral NSAID or steroid therapy, aggression or behavioral disorders, exercise intolerance, recent (< 3 months) joint injections of non-cell or platelet derived products, or recent (< 6 months) elbow joint surgery.

    Arms / Interventions:   This is a single arm open-label pilot study of 6 patients.  The elbow joint of the lamer limb will be injected with hESC-MSCs.  The joint injections will be performed with standard sterile technique, under heavy sedation.

    Potential direct or indirect benefits from the study:   The study will cover all costs associated with screening candidates including radiographs and associated sedation.   The study will also cover the costs of administering the hES-MSC treatment and all follow up hospital visits and exams, including initial and 2, 4, 8, and 12 weeks.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification:  CSRC 045-13, approved 11/19/13
    Sponsor:  Advanced Cell Technology, Marlborough, MA
    Principal Investigators:  Elizabeth Rozanski, DVM, DACVIM / DACVECC ext 84542, and Claire Sharp DVM, MS, DACVECC, ext 87934
    Contact information:  Elizabeth.rozanski@tufts.edu, (508) 839-5395, Ext 84745
    Status of trial:  Enrollment start date Jan 27, 2014.

    Inclusion Criteria:   Six dogs of either sex with a clinical diagnosis of abdominal sepsis due to GI perforation, whose owner has elected surgery, will be enrolled with owner consent. Diagnosis of abdominal sepsis is established by cytological evaluation of abdominocentesis fluid, confirming the presence of intracellular bacteria (e.g. bacteria visualized within neutrophils).   Abdominocentesis is clinically prompted by abdominal pain, fever, and effusion visualized on radiographs or by ultrasound.

    Exclusion criteria:  Dogs will be excluded from the study if they have GI perforation associated with neoplasia since this etiology is more likely associated with systemic disease, and potentially a worse outcome. GI neoplasia will be identified via abdominal ultrasonography confirming either a solitary GI mass, or enlarged abdominal lymph nodes and diffusely thickened intestinal loops consistent with GI lymphoma. Additionally, dogs will be excluded if they present in a moribund state and are not expected to survive initial stabilization and surgical exploration. Given the daily blood collection associated with this study we will exclude dogs weighing less than 5kg.

    Arms and interventions:   This is a single arm open-label pilot study.   Dogs in this study will receive intravenous hES-MSCs following gastrointestinal surgery and recovery from anesthesia.

    Potential direct or indirect benefits of participation:   The study will cover some of the costs of your dog’s care, including $500 towards the cost of surgery to repair the intestinal leakage, laboratory testing to monitor your pet’s progress.

    Contact Information

    • Please contact the Clinical Trials Technician to initiate screening for enrollment and for follow-up of enrollees:  Ms. Dawn Meola (dawn.meola@tufts.edu, 508 887 4589).
    • To reach the Principal Investigator, see contact information listed above.
    • For all other questions concerning clinical trials, please contact Dr. Andrew Hoffman (Director, Regenerative Medicine Laboratory) at andrew.hoffman@tufts.edu.
  • Protocol identification: CSRC 043-13, approval pending clarifications.
    Sponsor: Advanced Cell Technology, Marlborough, MA
    Principal Investigator: Dominik Faissler, DVM, Diplomate ECVN (Neurology)
    PI contact information: dominik.faissler@tufts.edu, (508) 839-5395 ext 88758
    Status of trial: Anticipated enrollment start date: Jan 27, 2014.

    Inclusion criteria: Chondrodystrophic dogs, any sex, any age range, weight (5-20 kg bwt), paraplegia with absent pain perception in hind legs and tail at admission; extradural compression between T3-L3 diagnosed with myelogram, CT or MRI. Acute disk extrusion confirmed at surgery.

    Exclusion criteria: Unable to confirm intraoperative disk extrusion, concurrent disease that could interfere with neurologic recovery, inability to obtain in-hospital follow-up performed at Tufts University by the neurology service, or lack of owner consent.

    Arms / interventions: This is an single arm open-label pilot study. Dogs which quality will receive a single subdural injection of hES-MSCs at the time of hemi-laminectomy.

    Potential direct and indirect benefits from participation: The study will cover the costs of the stem cell therapy, and recheck examinations at 1, 3, 7, 14, and 42 days and 12 wks, and bloodwork at 7, 14, and 42 days and 12 weeks after hES-MSC treatment.

  • Description:

    Cancer is one of the most common conditions seen in older dogs and it is becoming more common for owners to opt to treat their pets with chemotherapy.  Dogs undergoing chemotherapy may suffer from side effects of treatment such as vomiting, diarrhea, and reduced appetite.  There are currently no commercial diets that are designed specifically to help support dogs with cancer undergoing chemotherapy by reducing the gastrointestinal side effects of chemotherapy.

    The purpose of the study is to determine whether a specially formulated diet may reduce gastrointestinal side effects associated with chemotherapy and improve quality of life of dogs undergoing chemotherapy.

    Inclusion Criteria:

    • Dogs > 1 year of age with multicentric lymphoma (LSA) and grade 2 or higher mast cell tumors (MCT) that will be treated with standard (non-metronomic) chemotherapy protocols at a participating study site.
    • Weight > 5 kg, temperament suitable for drawing blood without sedation
    • All dogs should be naïve to treatment for the current cancer, but can have been treated for other cancers in the past if greater than 1 year prior.

    Exclusion Criteria:

    • Other diseases expected to potentially decrease quality of life, alter survival time, or limit diet options – e.g. significant heart disease, kidney disease, bad liver disease, etc.
    • Current vomiting or diarrhea or a history of chronic vomiting or diarrhea (more than 6 multi-day episodes per year or one month of consistent clinical signs) within the last year that required medications or special diet for control
    • Dogs with anticipated life expectancy of < 4 months
    • Pet owner not willing to feed prescribed diet and limit treats to 5% of calories

    Dogs will be fed either a high quality control diet appropriate for dog maintenance or the specially designed study diet – neither the pet owners nor the researchers will know which diet the dog is getting. Pet owners will need to fill out quality of life surveys as well as diet journals and fecal score journals every 1-2 weeks, and bring their dogs in for study visits/chemotherapy every 2 weeks. At three points during the study, blood and urine will be collected from fasted dogs.

    Treats and dietary supplements will need to be restricted to only those provided on an approved treat and supplement list.

    Client Benefits:

    The study will cover the costs of all study-related blood work and visits.  You will also receive free high quality pet food for the two month study duration and a $300 credit towards your account balance when you and your dog successfully complete the study and return all study-related paperwork.  The study does not include the costs of cancer staging (including those required to determine study eligibility), or any costs associated with surgery or chemotherapy, additional blood work not required for the study, or follow-up visits outside of those described above.  Your dog’s participation will also allow us to gain information which will help in the management of other dogs undergoing chemotherapy.

    Contact Information:

    To make an appointment with the oncology department please call the oncology liason, Kelly Reed at 508-887-4682

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at:  clinicaltrials@tufts.edu

  • Title: Evaluating hypercoagulability in dogs with brachycephalic airway syndrome: similarity to human obstructive sleep apnea.

    Description:

    The primary purpose of the study is to determine whether English Bulldogs are more hypercoagulable than non-brachycephalic dogs by running a series of coagulation tests. We are also interested in determining if C-reactive protein, a marker of inflammation and cardiovascular risk, is elevated in English Bulldogs as it is in humans with obstructive sleep apnea.

    Inclusion Criteria:

    English Bulldogs that have not undergone upper airway surgery and are currently exhibiting clinical signs consistent with the brachycephalic airway syndrome as documented by their owner (loud upper airway noise, snoring).

    English Bulldogs that are between 2 and 8 years of age, any sex or weight.

    Exclusion Criteria:

    English Bulldogs known to have a condition that will affect coagulation status, such as neoplasia, hemolytic anemia or thrombocytopenia.

    English Bulldogs taking medication that may affect its coagulation parameters, such as non-steroidal anti-inflammatory drugs, warfarin, low molecular weight heparin, clopidogrel, aspirin, or prednisone.

    English Bulldogs that have had surgical correction of their upper airway abnormalities (ie. Palatoplasty and rhinoplasty) to resolve/improve brachycephalic airway signs.

    Client Benefits:

    The study will cover the costs of routine bloodwork as well as coagulation tests and C-reactive protein analysis. Your dog’s participation will also allow us to gain information which will help in the treatment of other dogs with this condition.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

  • Description: Congenital heart defects occur in a variety of dog breeds, with the most common being the patent ductus arteriosus (PDA).  Although this is a correctable disorder in most puppies, it requires surgery or a catheter-based procedure which can be expensive and is not without risk.  Therefore, determining the genetic cause of PDA in dogs would be highly desirable so that dogs could be screened and the genetic mutation could be eventually bred out of the canine population.  Corgis are a breed at increased risk for PDAs, so the goal of this study is to evaluate Corgis with and without PDAs in order to identify the gene mutation for this heart problem.

    Inclusion Criteria:                                      

    Pembroke Welsh Corgis with a documented PDA will be studied.

    Exclusion Criteria:

    Breeds other than Pembroke Welsh Corgis.

    Client Benefits:

    The study will cover the cost of an echocardiogram (ultrasound of the heart) as well as a blood sample for DNA testing.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

  • Description: Acute radiation-induced dermatitis (ARID) is a common sequela of radiation therapy in both humans and dogs, arising in greater than 80-90% of patients undergoing definitive intent radiotherapy. Although relatively short-lived, skin reactions can be painful and itchy (which promotes secondary self-trauma in veterinary patients) and occasionally may necessitate dose reductions or treatment delays, which carry the potential to compromise tumor control. Another complication of radiation dermatitis is secondary infection. Although antibiotic use in the management of canine ARID is common practice amongst veterinary radiation oncologists, this management practice lacks evidence to support its use. The primary objective of this study is to evaluate the effect of prophylactic cephalexin antibiotics on rate of bacterial infection in ARID in dogs undergoing definitive-intent radiotherapy of the skin or subcutaneous tissues. Secondary objectives include characterization of the bacterial pathogens encountered in ARID as well as their antibiotic susceptibility.

    Inclusion Criteria

    1. All dogs must have a histologically or cytologically confirmed skin or superficial soft tissue cancer, including soft tissue sarcomas, mast cell tumors, cutaneous melanoma, plasma cell tumors, infiltrative lipomas, and carcinomas.
    2. All dogs must be treated with definitive intent radiotherapy, defined as dose ≥45 Gy or higher.
    3. Prior surgery or chemotherapy is acceptable with a 2-week washout.
    4. Prior glucocorticoid therapy is allowed if the patient has been on this therapy for a minimum of 2 weeks prior to Day 0.
    5. Prior antibiotic therapy is acceptable within a 1-week washout from the start of radiotherapy.
    1. Dogs should be otherwise in good health, a candidate for daily anesthetic episodes, and must have adequate organ function as determined by blood work and urinalysis.
    2. Any homeopathic/alternative therapies for cancer must be discontinued prior to enrollment.

    Exclusion Criteria

    1. Tumors located in the oral or nasal cavities, on the muzzle, or in the perineal region.
    2. Dogs that had a surgical flap procedure at the radiation site.
    3. Dogs that experienced a post-operative surgical infection.
    4. Dogs that require concurrent chemotherapy.
    5. Dogs that have received prior radiation therapy to the tumor site.
    6. Dogs that are currently on antibiotic therapy.
    7. Dogs with pre-existing dermatopathies.

     

    Client Benefits

    The study will cover the costs associated with skin culture and impression cytology. In addition, the exam fee for the recheck at 1 week post-radiation therapy is at no cost. The client will be responsible for all other costs associated with the radiotherapy course as well as the cost of all medications. The client is expected to make and keep all appointments, according to the clinical trial protocol once enrolled.

     

    Have a case?  

    Contact Dr. Michele Keyerleber at (508) 887-4682 or   Michele.Keyerleber@tufts.edu

  • Description:

    Recent studies in the human literature have documented that quicker lactate clearance is associated with improved survival in trauma patients.  It is currently unknown if a similar trend exists in canine trauma patients.  Our goal is to examine lactate clearance in canine trauma patients; samples will be taken at admission, and 2 and 4 hours after admission.

    The purpose of the study is to determine whether lactate predicts how well dogs that have experienced trauma will do overall and whether or not they will need blood transfusions.

    Inclusion Criteria:

    Dogs presenting with trauma (any kind) AND a lactate of ≥4 mmol/L at time of admission.  Prior treatment is allowed.

     Exclusion Criteria:

    Dogs presenting with trauma but having a lactate < 4 will be excluded; dogs that have a physiologic or pathophysiologic cause of hyperlactatemia that is not related to trauma will be excluded.  Such patients could include those with neoplasia, those with hepatic disease, those who are taking steroids, or those which have had a seizure in the 6 hours prior to presentation.

     Client  Benefits:

    The study will cover the costs of the three blood tests. Your pet’s participation will also allow us to gain information which will help in the diagnosis/management/treatment of other dogs that have experienced trauma

     Contact information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

     

  • Description:

    Canine borreliosis has been associated with renal failure and death (“Lyme nephritis’) although causation remains speculative. The Ixodes tick in Northeastern U.S. transmits Borrelia burgdorferi, Anaplasma phagocytophilum, and Babesia microti. Babesia microti-like organisms have been associated with anemia, renal failure, and death in dogs in Spain. Babesia microti is known to infect humans and foxes in the Northeastern United States.  We intend to investigate the incidence of babesial infection in dogs with signs suggestive of Lyme nephritis.  We hypothesize that renal failure and death attributed to borrelial infection in dogs (“Lyme nephritis’) is due to infection or co-infection with a Babesia microti-like organism.

    As a control group, we will be obtaining blood samples from dogs presenting to Tufts Foster Hospital for Small Animals for surgical repair of cruciate ligament disease for the presence of Babesia microti-like DNA.

    Inclusion Criteria:                                           

    Control dogs: Healthy dogs presenting for surgical repair of cruciate ligament disease.

    Client Benefits:

    The study will cover the costs of blood testing for Babesia microti-like infection, heartworm disease and exposure to the infectious organisms Ehrlichia canis, Anaplasma phagocytophilum and Borrelia burgdorferi. Your pet’s participation will also allow us to gain information which will help in the diagnosis and management of other patients.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

  • Description:         

    Carcinomas are a common form of malignancy in both dogs and humans. As a category of cancer, carcinomas tend to be both locally invasive as well as carry a high risk of locoregional metastasis. In cases diagnosed in early stages, long term survival is often possible with a combination of surgery, definitive radiation therapy, and conventional chemotherapy, but such multimodality therapy is often cost prohibitive for many clients. Furthermore, surgery may not be an option for some patients. Therapy is often limited to palliative radiation therapy (PRT) +/- conventional chemotherapy.  The purpose of this study is to evaluate therapy with toceranib (Palladia®), an oral anticancer agent, in combination with palliative radiation therapy for tolerability, toxicity, and efficacy in a population of dogs with measurable carcinomas.

    Inclusion Criteria:

    1. Age: At least one year old on Day 0.

    2. Body weight: Dogs must weigh at least 5.0 kg on Day 0

    3. All dogs must have a histologically or cytologically confirmed carcinoma, including anal sac adenocarcinoma, ceruminous gland carcinoma, mammary gland carcinoma, nasal carcinoma, prostatic carcinoma, salivary gland carcinoma, sebaceous adenocarcinoma, squamous cell carcinoma, rectal carcinoma, thyroid carcinoma, or transitional cell carcinoma of the urethra.

    4. The patient must have measurable disease at the primary tumor site and/or metastatic lymph nodes.

    5. Prior surgery or chemotherapy is acceptable with a 2-week washout.

    6. Prior NSAID therapy is allowed if the patient has been on this therapy for a minimum of 2 weeks prior to Day 0.

    7. Dogs must have adequate organ function as indicated by standard laboratory tests: (hematology (CBC), clinical chemistry and urinalysis). Specifically, dogs must have:

    a. Absolute neutrophil count (ANC) > 2,000 cells/μL

    b. Hematocrit > 25%

    c. Platelet count > 100,000/μL

    d. Serum creatinine < 2.5 mg/dL

    e. Bilirubin ≤ the upper normal limit

    f. Transaminases ≤ 3 times the upper normal limit or if > 3 times the upper normal    limit then serum bile acids must be ≤ the upper normal limit

    8. The animal must have a performance status of either 0 or 1 on Day 0, according to the      activity; 1, restricted [decreased activity from predisease status]; 2, compromised [ambulatory for only vital activities, urinates and defecates in appropriate areas]; 3, disabled [requires force feeding, unable to urinate and defecate in appropriate areas]; 4, dead.

    9. The animal must be a fair to excellent anesthetic candidate for 10 daily anesthesias, defined as an anesthetic risk status of I to III on the following scale:

    I. Excellent anesthetic risk: This includes normal, healthy patients.

    II. Good anesthetic risk: This includes patients with mild systemic disease, such as    geriatric or neonatal patients, localized or compensated disease.

    III. Fair anesthetic risk: This includes patients with moderate systemic disease including those with low to moderate fever, moderate dehydration, anorexia/cachexia, chronic cardiac disease, chronic renal disease.

    IV. Poor anesthetic risk: These patients have severe systemic disease that is a constant threat to life, including shock, high fever, toxemia, severe dehydration, severe anemia, diabetes, decompensated cardiac/renal/hepatic disease, severe pulmonary disease affecting gas exchange.

    V. Guarded anesthetic risk: This includes moribund patients not expected to survive 24 hours including those with advanced multiorgan system failure, severe shock, DIC.

    10. The owner must have provided written, informed consent prior to enrolling in the study.

    Exclusion Criteria:

    1. Dogs with adrenocortical carcinoma, gastrointestinal carcinoma, hepatic carcinoma, pulmonary carcinoma, renal carcinoma, or transitional cell carcinoma of the urinary bladder.

    2. Dogs that have received chemotherapy within 2 weeks of Day 0.

    3. Dogs that have received prior radiation therapy to the tumor site.

    4. Concurrent malignancy or other serious systemic disorder (renal disease, cardiac disease, respiratory disease) incompatible with this study.

    5. Dogs that are on homeopathic/alternative therapies for their cancer. These should be discontinued on Day -1. Supplements such as chondroitin sulphate, essential fatty acids and glucosamine are permitted during the trial period.

    6. Dogs with protein-losing nephropathy (UPC > upper limit ref range).

    7. Dogs with an anesthetic risk status of IV or V on the above scale.

    Client Benefits:

    The study will cover the following costs associated with your participation in this clinical trial: the cost of Palladia for 12 weeks, $1250 towards radiation therapy, one set of chest x-rays (at week 12), and recheck exam fees at week 3, 4, 6, and 12 of the study. This amounts to a total financial benefit of approximately $2200. You will be responsible for general anesthesia and costs for the CT scan (if required); all radiation therapy costs beyond $1250; all costs associated with monitoring blood work and urinalyses during the study period and beyond; and any diagnostic tests (x-rays, abdominal ultrasound, etc.) and recheck exam fees beyond week 12. Your pet’s participation will allow us to gain information which will help in the treatment of other dogs with carcinoma.

    Contact Information:

     For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

     

  • Description:

    The purpose of the study is to determine whether the administration of canine umbilical cord derived mesenchymal stem cells (UC-MSCs) is safe, and if it will reduce kidney injury to a greater extent than the current standard of care. The study will measure kidney values to see if they stay in or return to a normal range as well as overall survival. Secondarily, the study will monitor for any changes in your dog’s likelihood to form blood clots.

    Inclusion Criteria:

    Dogs presenting with protein-losing nephropathy, hypoalbuminemia (<2.0 g/dl), azotemia (creatinine >2.0), thrombocytopenia (platelets < 160,000), and a hypercoaguable state.

    Any gender, and any breed, weighing > 4 kg (8.8 pounds).

    Able to come back for recheck appointments on days 2, 7, 14, 30 and 3, 6 and 12 months post injection.

    Exclusion Criteria:

    Dogs weighing less than 4 kg (8.8 pounds)

    Dogs not expected to live greater than 48 hours, those with cardiac disease, and those with neoplasia.

    Also excluded will be those dogs with an active bacterial urinary tract infection, and those suspected or confirmed to have leptospirosis.

    Client Benefits:

    The study will cover some of the costs that are typically acrued in the diagnostic evaluation of dogs with protein-losing kidney disease including complete blood count, chemistry profile, urinalysis, urine culture, urine protein creatinine ratio, thromboeslatograph (a clotting profile), antithrombin level (to see if your dog is at risk for forming blood clots), ANA (looking for lupus, an autoimmune disease) , serology for tick borne diseases and leptospirosis. It will also cover an abdominal ultrasound examination and the cost of a kidney biopsy. Kidney biopsy is part of the standard diagnostic workup for dogs with protein-losing kidney disease permits it (not too anemic, platelet count adequate, and not hypertensive). The risks associated with kidney biopsy are blood loss from the biopsy site. Your dog will be monitored closely for 4 hours after the biopsy to make sure that any bleeding stabilizes. Heart rate, respiratory rate, mucus membrane color, and blood count will be monitored hourly. Should there be any evidence of sustained bleeding, your dog will be administered intravenous fluids and if needed a blood transfusion. The cost of the blood transfusion will be the responsibility of the owner. The study will also cover the cost for follow up blood work at the scheduled rechecks during the 365 days of the study. Your pet’s participation will also allow us to gain information which will help in the diagnosis/management/treatment of other dogs with this condition. You understand that your animal’s participation in this study may not alleviate or cure his/her ailment.

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu

  • Description:

    The purpose of the study is to determine if increasing levels of the hormone progesterone found in the serum (bloodstream) of female dogs during their reproductive cycle leads to hypercoagulability (excessive blood clotting).

    Inclusion Criteria:

    Female dogs will be recruited in the following groups.

    1) Healthy, spayed females

    2) Healthy intact female in anestrus

    3) Healthy non-pregnant dogs in diestrus (estimated in 6-8 weeks post ovulation)

    4) Healthy pregnant dogs (45-60 days pregnant)

    5) Dogs during labor and delivery (C-section/dystocia)

    6) Dogs with pyometra occurring during diestrus

    Client Benefits:

     

    The study will cover a test measuring progesterone levels and thromboelastography, a test that evaluates the entire clotting process in a patient. Your pet’s participation will also allow us to gain information which will help in the management and treatment in dogs with this condition.

     

    Contact Information:

    For questions regarding the clinical trial please email the clinical trials technician, Diane Welsh at: clinicaltrials@tufts.edu