Clinical Trials
Submitted protocols are reviewed by both the Clinical Protocol Review Committee (LSU SVM Department of Veterinary Clinical Sciences) and LSU’s Institutional Animal and Care Use Committee (IACUC) with the intent to ensure that welfare and confidentiality matters are observed. These reviews are patterned on “Good Clinical Practices” for conduct of clinical trials in human medicine.
FURTHER INFORMATION ON GOOD CLINICAL PRACTICES
Summary
Hypercalcemia is frequently associated with intermediate to high-grade T-cell lymphoma in dogs. Calcium is used as a biochemical marker to evaluate the response to treatment, and hypercalcemia is considered a negative prognostic factor in canine lymphoma. In veterinary literature, hypercalcemic B-cell lymphoma is extremely rare. To date, the incidence and clinical significance of hypercalcemia in intermediate to high-grade B-cell lymphoma, which is the most common form of canine lymphoma, remain unknown.
Total blood calcium consists of three primary forms, including ionized calcium, protein-bound calcium, and complexed calcium. Ionized calcium is the biologically active form of calcium, and to accurately evaluate calcium status, direct measurement of ionized calcium concentration is necessary. However, in clinical practice, the calcium status of animals is typically determined based on total calcium concentration. Unfortunately, total calcium concentration has a poor correlation with ionized calcium concentration and does not reflect the true calcium status of the animal. Additionally, there is controversy surrounding the correlation between total calcium concentration and ionized calcium concentration in dogs with lymphoma.
Our study aims to examine a cohort of dogs that have recently been diagnosed with intermediate to high-grade B-cell lymphoma and have not received any prior lymphoma treatment to assess their ionized calcium concentration at the time of diagnosis. Additionally, we intend to evaluate the correlation between total calcium concentration and ionized calcium concentration in the study's dog population. Dogs with intermediate to high-grade T-cell lymphoma are also evaluated as a contemporary control group. Finally, we will compare the severity of ionized hypercalcemia between the intermediate to high-grade B-cell lymphoma and T-cell lymphoma groups.
The patients included in this study have a confirmed diagnosis of intermediate to high-grade lymphoma based on cytology or histopathology. Additionally, they have not received steroid administration concurrently or within two weeks prior to their lymphoma diagnosis, and they have not undergone chemotherapy for lymphoma. Upon enrollment, patients will have bloodwork performed at LSU, which will include total calcium, ionized calcium, and albumin concentrations. Immunophenotyping will also be conducted using one of the following methods: flow cytometry, immunocytochemistry, immunohistochemistry, or PARR assay.
Eligibility
- Dogs diagnosed with treatment-naïve, intermediate to high-grade lymphoblastic lymphoma via cytology or histopathology
- Dogs that have NOT had steroid administration concurrently or within two weeks prior to lymphoma diagnosis
- Dogs with NO prior or concurrent chemotherapy for lymphoma
Benefit
The study covers the cost of bloodwork and immunocytochemistry.
Contact
Jiaqi Li (Kate), DVM
Medical Oncology Resident
Department of Veterinary Clinical Sciences
Louisiana State University
School of Veterinary Medicine
1909 Skip Bertman Drive
Baton Rouge, LA 70803
kate.li.dvm@gmail.com or jiaqili@lsu.edu
832-520-1382
Goal
The GI microbiome plays an important role in the digestive and general health of dogs. Antibiotics are commonly used, and their impact on the GI microbiome can be important and long-lasting. Our study will assess the benefit of fecal microbiota transplantation (FMT) performed using frozen fecal capsules given by mouth in accelerating recovery of the GI microbiome after a short antibiotic treatment in healthy dogs. We will collect feces from each dog prior to treating them with antibiotics and give each dog frozen FMT capsules made with their own feces. If we can demonstrate a faster recovery of the GI microbiome with oral FMT, our study might change how antibiotics are administered in clinical situations involving sick dogs.
Eligibility
We are recruiting healthy dogs between the ages of 1 and 10 years weighing between 8 and 24 kg. They should have no history of GI disease or antibiotic treatment in the last year. Finally, they should not be receiving any medication except heartworm preventative.
Components of the Study
- Each participant will receive a free physical examination by us, including basic blood work (CBC, chemistry), urine specific gravity and fecal parasitologic test to confirm good health status.
- Feces will be collected by you and processed by us to manufacture frozen FMT capsules
- Each participant will receive a 7-day antibiotic treatment (metronidazole) given by mouth twice daily
- Dogs will be randomly assigned to the test or the control group. Dogs in the test group will receive FMT immediately after antibiotic treatment, while dogs in control group will receive FMT 24 days after discontinuation of antibiotic. You will administer the frozen fecal capsules by mouth at a weight-dependent dose of 1 to 3 capsules twice daily for 10 days.
- Each dog will be enrolled for a total of 6 weeks. We will ask you to collect and bring us feces for analysis at 6 time points throughout the study duration.
Compensation
Upon completion of the study, each participant will receive $100 on a prepaid card.
How to Enroll
If you’re interested to enrol or have additional questions, feel free to contact: Dr. Yi Kwan (Jocelyn) Lee, DVM at ljocelyn@lsu.edu
Goals
Immune-mediated hemolytic anemia (IMHA) is a common disease that affects all breeds of dogs and can be fatal. It is an autoimmune disorder where the body makes antibodies that recognize your dog’s own red blood cells. These antibodies damage the red cells leading to their removal from the circulation - a process called hemolysis. The purpose of this study is to determine if OKV-1001 is safe and more effective than prednisone alone for the treatment of IMHA. OKV-1001 is a new formulation of a drug called mycophenolic acid (MPA) that is used in the treatment of IMHA.
Eligibility
Dogs presenting to the LSU Veterinary Teaching Hospital for IMHA.
Compensation
Your dog will benefit from the provision of diagnostic testing and follow-up monitoring at zero cost to you. You will be responsible for all costs related to standard-of-care treatment of IMHA including hospitalization, blood transfusions, costs of medications, etc. Any tests or procedures unrelated to the study are the responsibility of the owner.
How to Enroll
Email vet-research@lsu.edu and include the following:
- Pet owner name, email, and phone number
- Pet name, weight, date of IMHA diagnosis
- Referral clinic, referral veterinarian name, and phone number
Principal Investigators
Andrea Johnston, DVM,DACVIM (SAIM), PhD, Assistant Professor of Small Animal Internal Medicine
Frederic Gaschen, Dr.med.vet., Dr.habil., DACVIM (SAIM), DECVIM-CA (IM), AGAF, Professor of Small Animal Internal Medicine
Description
Have you seen a cat with goopy eyes recently? The Lewin Lab for Innovative Eye Research is currently searching for cats with ocular Feline Herpes Virus (FHV-1) for clinical trials. The trial is to test a new drug treatment modality for FHV-1.
We have developed a novel slow-release ocular implant that contains a well-known and commonly used antiviral drug. The purpose of this clinical trial is to test the efficacy and tolerability of this implant in cats with the feline herpes virus. Enrolled animals will receive either the ocular implant under general anesthesia or eye drops containing antiviral medications. All animals will receive topical ophthalmic antibiotics as well. Outcomes will be assessed using eye examinations, amount of virus shed and owner satisfaction surveys over a 90-day period.
Qualifications
FHV-1 will be confirmed or excluded during the first examination at LSU.
Prior testing does not have to have been performed at your clinic.
The patient must have ocular diseases consistent with FHV-1.
The patient must weigh over 1kg.
The patient must not have severe concurrent systemic disease.
The owner must agree to all of the study conditions listed in the protocol.
Cost
The owner is responsible for paying the initial LSU Ophthalmology Service examination fee of $178.50.
If eligible, pets will receive the following items free of charge.
- Free upper respiratory pathogen diagnostic panel
- Free feline herpes testing to monitor response
- Free treatment for FHV- 1
- Topical antibiotics for 14 days
- Either topical anti-viral medication for 14 days OR novel antiviral implant and associated general anesthesia
- 3 free follow-up examinations to assess the response to the treatments, at designated time points.
Benefits for Pets/Owners
If eligible, the pet will receive testing and treatment for FHV-1 at a minimal cost
to the owner
The pet’s participation in this study will aid in scientific advancement to develop
a new antiviral implant to treat FHV-1, which could help thousands of animals in the
future.
Contact
If you are interested in participating in this clinical trial, please contact us at the information below for further consideration:
Dr. Erinn Mills
LSU Small Animal Clinic
(225)-578-9600
Call for Dogs with Active Clinic Signs of Pythium Infection
Summary
The organisms Pythium, Lagenidium and Paralagenidium are frequently encountered in the southeastern United States, particularly in Louisiana. These are aquatic fungus-like organisms that can cause devastating and extremely difficult to treat disease of the skin and / or gastrointestinal tract in dogs. Response to medical management is often poor, and the lesions often return after surgical excision.
The purpose of this study will be to determine the ability of an immune stimulating bacterial extract to enhance the immune response to infections with these organisms in dogs.
Inclusion Criteria
- Dogs must have active clinical signs compatible with cutaneous infection with Pythium, Lagenidium, or Paralagenidum.
- The diagnosis will be confirmed by histopathology (biopsy), culture, and immunological or molecular analysis (PCR and or ELISA).
- Patients must fit the following criteria:
- Lesion recurrence after surgical excision
- Surgical excision not recommended based upon location or extent
- Surgical excision declined by owner
- Clients must be willing to participate in a placebo controlled study
- Clients must be willing and able to return the patient for scheduled rechecks
Exclusion Criteria
- Patients with current or recent treatment with steroids
- Patients with concurrent medical issues will be evaluated individually for inclusion in this study
Description of the Study
- The study will require 17 visits to LSU School of Veterinary Medicine
- All patients will be treated with a current medical management protocol
- Patients will also receive intradermal injection of either a killed bacterial product or placebo (saline)
- Blood and skin biopsy samples will be acquired periodically to enable evaluation of the patient’s immune response
- Antibody level testing will also be performed periodically in patients infected with
Cost
- The study will pay for all visits, examinations, intradermal injections, and the costs associated with acquiring skin biopsy samples
- The study will not cover CBC and chemistry (evaluation of organ function), antibody level testing (Pythium patients only) and medications other than the study compounds. The study also will not cover costs for pathology, culture and immunological or molecular analysis (if these procedures have not already been performed prior to enrollment in the study).
Contact
To find out more about the study and the possibility of enrolling your dog, please contact the LSU small animal clinic (225 578-9600). Referring veterinarians should contact the dermatology service for further information.
Call for Dogs with Soft Tissue Sarcoma
Summary
Repurposing drugs to modulate myeloid-derived suppressor cells (MDSCs) in canine soft tissue sarcomas (STS)
Presently available systemic treatments for canine STSs are largely ineffective. Limitations to applying immunotherapeutic strategies, that have demonstrated activity against human cancers, in canine oncology include: 1) the cost of developing therapeutics specifically for dogs since immunotherapeutics are typically species-specific; and 2) insufficient knowledge regarding the immunosuppressive forces at work within veterinary tumors. Furthermore, veterinary medicine cannot rely on advances to be passed down from human medicine due to the rarity of sarcomas in people.
The goal of this study is to define the immunosuppressive effects of MDSCs within canine STSs, and uncover the potential for readily available pharmaceuticals to alter MDSC function. Therefore, these data will provide a rationale for subsequent clinical trials exploring the efficacy of MDSC modulation in clinical canine patients.
All experiments are ex vivo, i.e. they do not require delivery of experimental drugs to pet dogs. Cells from the blood (60 ml collected 4-14 days prior to tumor excision) and tumor will be extracted for the purposes of studying immune cell characteristics and their modulation by repurposed drugs. Sedation MAY be required for blood collection.
Financial Incentive
Participation will result in a credit for the cost of blood collection, a complete blood count (CBC), serum biochemistry, and thoracic radiographs (~$330 total).
Inclusion Criteria
- Presence of a cutaneous/subcutaneous soft tissue sarcoma (diagnosed via cytology)
- Surgical excision is recommended as treatment of choice
- Owners have elected surgical excision of the target soft tissue sarcoma
- Tumor size >2cm (~3/4 of an inch) diameter
- Patient weight > 15kg
- CBC, chemistry, thoracic radiographs performed within 2 weeks of surgical excision
- Signed owner consent form
Exclusion Criteria
- Incisional biopsy performed within 4 weeks of anticipated surgical excision
- Administration of immune modulating medications such as non-steroidal anti-inflammatories, steroids, chemotherapy, immunosuppressants etc. within 2 weeks of tumor removal
- Prior radiation therapy administered to the target soft tissue sarcoma
- Preexisting autoimmune disease
- Preexisting disease or medication history that would induce coagulopathy
- Evidence of pulmonary metastasis
Call for Dogs with Urine Preservation Study
Criteria
In search of 35 dogs for a urine preservation study, including any but not limited to:
- Dogs with Lower Urinary Tract signs
- Dogs with the following diseases(any but not limited to):
- Hyperadrenocorticism
- Diabetes mellitus
- Metabolic Disease
- Immune-Mediated Diseases
- Infectious Diseases
Requirements
Participation involves a simple Free Catch urinalysis.
Study will cover the cost of urinalysis.
Contact
To see if your dog qualifies and is able to participate, please contact Dr. Laura Adams at LAdams10@lsu.edu or 516-672-6410 or Dr. Harmeet Aulakh at haulakh@lsu.edu or 217-722-1631.
Call for Long-haired Dogs without Skin Diseases
Residual antibacterial activity on the skin surface and hair shafts following treatment with five different topical mousse products
Description
The objective is to determine the anti-bacterial effectiveness of commercial antiseptic mousse products.
Your dog will be bathed at home 3 days prior to the start of the study with a general maintenance shampoo. On day 0 (study start), your dog will present to the teaching hospital. 5 patches of fur will be clipped on your dog’s chest and abdomen. 3 patches will be on the left side and 2 on the right. Following clipping, the 5 different mousse products will be applied to your dog’s hair coat by Dr. Wu. This is a double-blinded study, therefore neither Dr. Wu nor you will know which mousse was applied to which location. Your dog will need to report back to the teaching hospital on days: 2, 4, 7, 10 and 14 of the study for hair samples and skin surface swab collection. At each re-check, a small hair sample will be clipped from each patch, and cotton swabs will be rubbed on the skin surface. These samples will be used to test for antibacterial activity of the tested mousses.
Criteria
- At least 3 months of age
- Overall good health
- No evidence of skin disease
- Long-haired (in average 4 cm hairs)
- Weighs more than 20 lbs (or 10 kg)
- Have not received any systemic antimicrobials, systemic antifungals, or any topical antimicrobial therapies in the 4 weeks prior to enrollment
Call for Dogs with Presumed or Confirmed Osteosarcoma
Purpose
To gather fresh canine osteosarcoma samples to study the anti-tumor canine immune response
Criteria
- A dog with a presumed or confirmed osteosarcoma undergoing a limb amputation.
- Confirmation from Sarah Keeton that the case is suitable.
- Notification of Sarah Keeton at least 24 hours prior to the date of amputation.
- The ability to make the following available for pick up on the day of amputation:
- The unfixed amputated leg
- The completed LADDL submission form containing the grant number (provided by Sarah Keeton upon request)
Costs Covered
- The cost of the transportation of the limb to the LADDL pathology lab at LSU
- Histopathology fees to confirm the diagnosis
Contacts
Sita Withers, BVSc(Hons), PhD, DACVIM(Onc) at withers1@lsu.edu
Sarah Keeton, PhD at sorlik1@lsu.edu
Call for Cats with Non-resectable Tumors
Description
Title: Effect of amantadine on quality of life in chronic feline cancer pain
Amantadine is a pain medication given orally in dogs and people. Amantadine’s effectiveness has not been tested in cats. This clinical trial will study the effects of the medication on the quality of life in cats with non-resectable cancer. The medication will be given either in combination with other palliative therapies or alone. Some cats will receive a placebo in place of amantadine in combination with another known pain reliever. Enrolled patients will undergo therapy over a 6 week period. During that time, quality of life will be measured both by the pet’s caretaker and the examining doctor every 2 weeks. At the end of the 6 weeks, the study will be discontinued.
Criteria
Mature cats with cancer with a confirmed diagnosis and at least 6 weeks of life expectancy. The cancer must have the potential to impact quality of life. Cats currently on some other treatment modality will be considered for inclusion. Cats must not be on concurrent chemotherapy and cats on corticosteroids or NSAIDs must have a 2 week washout period prior to study enrollment.
Costs Covered
The study will cover the cost of 6 weeks’ worth of the oral amantadine as well as one CBC and Chemistry test (blood work), 3 physical exams, and 3 office visits. Further details of items covered, or not, can be discussed at the time of request for enrollment.
Contact
To find out more about the study and the possibility of enrolling your pet/patient contact the LSU Small Animal Clinic (225-578-9600) to schedule an Oncology Appointment. Referring DVMs, please contact the Oncology Service Directly.
Call for Dogs with Multicentric Lymphoma
Description
Title: Prospective evaluation of the efficacy of vincristine in dogs with treatment-naïve high-grade multicentric lymphoma
While vincristine chemotherapy is part of the “standard-of-care” for canine lymphoma (i.e. CHOP multiagent chemotherapy), the efficacy of vincristine alone is not known. Meanwhile, immune-suppressive cells (myeloid-derived suppressor cells (MDSCs)) are known to inhibit anti-tumor immune responses, however their prevalence in dogs with lymphoma and the ability of chemotherapy to modify their numbers in the blood has not been investigated. This study aims to address these deficits in our understanding of canine lymphoma.
Dogs with newly-diagnosed multicentric, high-grade lymphoma who have not received any previous anti-cancer treatment, may be eligible for enrollment if they meet the below criteria. On day 0, participating dogs will have their lymph nodes measured, a blood sample drawn, and will receive an injection of a standard dose of vincristine. On day 7 we will re-measure the lymph nodes and draw another blood sample. The study is then complete, and dogs can receive whichever treatment is elected by their owners after discussion with the overseeing clinician.
In undertaking this study, we hope to elucidate the response rate of vincristine alone in canine lymphoma, in addition to uncovering the impact of lymphoma treatment on the proportion of blood MDSCs.
Benefits and Costs Covered
Your pet’s participation in this study will:
- Result in us covering the cost of immunophenotyping via immunocytochemistry (approximately $73), or crediting your account with this amount if this test has already been performed
- Help us to understand how critical vincristine is in the treatment of canine lymphoma
Help us to understand how the amount of blood MDSCs is altered by chemotherapy treatment in dogs with lymphoma - Ultimately help us to optimize treatment for dogs with lymphoma by maximizing efficacy and minimizing toxicity
- This study cannot cover the cost of any visit fees, diagnostics, or treatments, beyond the ~$73 for lymphoma immunophenotyping.
Criteria
Your dog may be a good candidate for this study if the following criteria are met:
- A diagnosis of lymphoma is made via cytology or histopathology
- You elect to start chemotherapy for treatment of the lymphoma
- The immunophenotype (T vs. B cell) is known or results are pending
- Weight more than 10kg
- There are no significant symptoms relating to the lymphoma that would necessitate supportive care
- No prior chemotherapy has been given
- Steroids are not being given
Contact
To find out more about the study and the possibility of enrolling your pet, please contact the LSU Small Animal Clinic (225-578-9600) to schedule an Oncology Appointment. RDVMs, please contact the Oncology Service directly.
Call for Dogs with Nasal Carcinoma
Description
Title: Immunomodulation in regional lymph nodes of dogs with nasal carcinoma treated with different external beam radiotherapy protocols
Radiotherapy (aka. radiation therapy) is known to stimulate an immune response against cancer in mouse models, and sporadically in humans. Almost nothing is known about how radiotherapy effects the immune response in dogs however. This information is critical to be able to harness these effects and maximize tumor response.
To address this need, we are undertaking a study evaluating immune responses in dogs with nasal carcinoma or sarcoma that are receiving radiotherapy. This study involves collecting a series of blood samples and lymph node fine-needle aspirates from enrolled dogs. Ultimately, we expect that the results obtained will allow us to better understand how the immune response is altered by radiotherapy.
Criteria
Dogs undergoing radiotherapy for nasal carcinoma or sarcoma are eligible for enrollment if they also meet the below criteria.
Your dog may be a good candidate for this study if the following criteria are met:
- A diagnosis of nasal carcinoma or sarcoma is made
- You elect radiotherapy for treatment of the nasal tumor
- No cancer spread is identified
- Weight more than 5kg
- No concurrent treatment with steroids
- No chemotherapy within a month of radiotherapy
- You can return for one additional clinic visit (at no cost to you) that is not routinely necessary for radiotherapy monitoring
Benefits and Costs Covered
Your pet’s participation in this study will:
- Result in a credit to your account in the amount of $100.
- Help us to understand how different radiotherapy protocols impact the immune system in dogs.
- Help us lay the foundation for future studies exploring ways to fight cancer by harnessing the effects of radiotherapy on the immune system.
This study cannot cover the cost of any visit fees, diagnostics, or treatments.
Contact
To find out more about the study and the possibility of enrolling your pet, please contact the LSU Small Animal Clinic (225-578-9600) to schedule an Oncology Appointment. RDVMs, please contact the Oncology Service directly.