Clinical Investigation Center

Completed Clinical Studies

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This section highlights our completed clinical trials and studies, with publication information if applicable. Publication links will take you to PubMed.

Cardiology

Cardiology

Amplatz Canine Duct Occluder studies

Investigators: Anthony H. Tobias, BVSc, PhD, Dipl. ACVIM (Cardiology), Thaibinh P. Nguyenba, DVM
This research involved the design and development of a novel device specifically to conform to the morphology of patent ductus arteriosus in dogs and a minimally invasive per-catheter procedure for device delivery in this species.

Publications:
Nguyenba TP, Tobias AH. Minimally invasive per-catheter patent ductus arteriosus occlusion in dogs using a prototype duct occluder. J Vet Intern Med. 2008 Jan-Feb;22(1):129-34
Nguyenba TP, Tobias AH. The Amplatz® Canine Duct Occluder: a novel device for patent ductus arteriosus occlusion.  Journal of Veterinary Cardiology 2007; 9: 109-117.

Body Fluid Volume and Cardiac Effects of Methylprednisolone in Cats

Investigators: Anthony H. Tobias, BVSc, PhD, Dipl. ACVIM (Cardiology), Sheila Torres, DVM, MS, PhD, DACVD
Cats that required corticosteroid therapy for dermatologic disorders were studied pre- and post-injection of methylprednisolone.

Publication: Ployngam T, Tobias AH, Smith SA, Torres SM, Ross SJ. Hemodynamic effects of methylprednisolone acetate administration in cats. Am J Vet Res. 2006 Apr;67(4):583-7.

Dermatology

Dermatology

Apoquel® in client-owned dogs with atopic dermatitis

Investigator (this site): Sheila Torres, DVM, MS, PhD, DACVD

This multi-site study looked at efficacy and safety of oclacitnib (Apoquel®) for the control of atopic dermatitis in a randomized, double-blind, placebo-controlled trial. Dogs had a reduction from baseline in owner-assessed pruritus scores and dermatologist CADESI-02 scores. Oclacitinib is now available as a prescription medication for dogs.

Publication: Cosgrove SB et al. A blinded, randomized, placebo-controlled trial of the efficacy and safety of the Janus kinase inhibitor oclacitinib (Apoquel®) in client-owned dogs with atopic dermatitis.Vet Dermatol. 2013;24:587-597.

Ceramide composition of the stratum corneum of canine patients with dermatitis. 

This study looked at the composition of the skin of dogs with allergies.  Decreased amounts of ceramides were found in the non-lesional skin of dogs with atopic dermatitis and may be involved in impaired barrier function of their skin. 

Publication: Reiter LV, Torres SM, Wertz PW. Characterization and quantification of ceramides in the nonlesional skin of canine patients with atopic dermatitis compared with controls. Vet Dermatol. 2009 Aug;20(4):260-6. 

Large Animal Medicine and Surgery

Large Animal Medicine and Surgery

The efficacy of imiquimod 5% cream (Aldara®) in the treatment of aural plaque in horses: a pilot open label-clinical trial.

Investigators: Sheila Torres, DVM, MS, PhD, DACVD; Erin Malone
This clinical trial of 16 horses (21 enrolled, 16 completed) found that topical application of imiquimod 5% cream was effective in treating aural plaques, a condition which affects 22% or more of horses. Cases were followed for up to 22 months and only two horses had recurrence of their lesions.

Publication: Torres SM, Malone ED, White SD, Koch SN, Watson JL. The efficacy of imiquimod 5% cream (Aldara® in the treatment of aural plaque in horses: a pilot open-label clinical trial. Vet Dermatol. 2010 Oct;21(5):503-9.

 

Efficacy of imiquimod 5% cream in the treatment of equine sarcoids: a pilot study. 

Principal Investigator: Sandra (Nogueira) Koch, DVM, DACVD
This pilot study enrolled 15 horses with sarcoid tumors of mixed type and location. Results showed 12/15 lesions reduced in size by >75%, and 9 resolved completely.

Publication: Nogueira SA, Torres SM, Malone ED, Diaz SF, Jessen C, Gilbert S. Efficacy of imiquimod 5% cream in the treatment of equine sarcoids: a pilot study. Vet Dermatol. 2006 Aug;17(4):259-65.

Aldara Frequently asked questions for Owners

Veterinarian Instructions for use of Aldara®(imiquimod)

Neurology

Neurology

Feasibility study of a caregiver seizure alert system in canine epilepsy

Abstract
A device capable of detecting seizures and alerting caregivers would be a major advance for epilepsy management, and could be used to guide early intervention and prevent seizure-related injuries. The objective of this work was to evaluate a seizure advisory system (SAS) that alerts caregivers of seizures in canines with naturally occurring epilepsy. Four dogs with epilepsy were implanted with a SAS that wirelessly transmits continuous intracranial EEG (iEEG) to an external device embedded with a seizure detection algorithm and the capability to alert caregivers. In this study a veterinarian was alerted by automated text message if prolonged or repetitive seizures occurred, and a rescue therapy protocol was implemented. The performance of the SAS caregiver alert was evaluated over the course of 8 weeks. Following discontinuation of antiepileptic drugs, the dogs experienced spontaneous unprovoked partial seizures that secondarily generalized. Three prolonged or repetitive seizure episodes occurred in 2 of the dogs. On each occasion, the SAS caregiver alert successfully alerted an on call veterinarian who confirmed the seizure activity via remote video-monitoring. A rescue medication was then administered and the seizures were aborted. This study demonstrates the feasibility of a SAS to alert caregivers to the occurrence of prolonged or repetitive seizures and enables rescue medications to be delivered in a timely manner. The SAS may improve the management of human epilepsy by alerting caregivers of seizures, enabling early interventions, and potentially improving outcomes and quality of life of patients and caregivers.

Publication: Coles LD, Patterson EE, Sheffield WD, Mavoori J, Higgins J, Michael B, Leyde K, Cloyd JC, Litt B, Vite C, et al. Feasibility study of a caregiver seizure alert system in canine epilepsy. Epilepsy Res.2013 Oct;106(3):456-60. doi: 10.1016/j.eplepsyres.2013.06.007. Epub 2013 Aug 18. PubMed PMID: 23962794.

Clinical characteristics and inheritance of idiopathic epilepsy in Vizslas.

Publication: Patterson EE, Da Y, Mickelson JR, Roberts MC, McVey A, O Brien D, Johnson GS, Armstrong PJ. (2003) Clinical characteristics and inheritance of idiopathic epilepsy in Vizslas. Journal of Veterinary Internal Medicine, 17(3): 319-325.

Visit the Canine Epilepsy Network website.

Oncology

Oncology

Fasaret for Canine Osteosarcoma

The goals of this clinical trial were to identify a safe dose of adenovirus-Fas ligand (Fasaret) administered into the tumor and to determine its efficacy in dogs with bone cancer treated with the standard of care. PMID: 22850679 

Study Outcomes
  • Therapy was safe
  • Patients where Fasaret induced inflammation in the tumor had improved outcomes
  • Dogs treated with Fasaret whose tumors had lower expression of Fas protein had longer survival
  • 40% of dogs that developed strong tumor inflammation survived more 1200 days

OSAL

The goals of this clinical trial were to identify a safe dose of oral recombinant Salmonella-IL2 and to determine its efficacy in dogs with bone cancer treated with the standard of care. doi/10.1002/vms3.32

Study Outcomes
  • Oral Salmonella IL-2 was safe Patients that received Salmonella IL-2 developed transient elevations in white blood cell counts
  • Salmonella IL-2 was associated with longer remissions than what was expected with standard of care alone
  • About ~20% of the treated dogs survived more than 700 days

The KPT-335 Family of Trials

The goals of these clinical trials were to identify a safe dose of Verdinexor (KPT-335) and to determine its efficacy in dogs with lymphoma. PMID: 24503695

Study Outcomes
  • Verdinexor was safe and effective
  • These trials contributed to the approval of Verdinexor for use as treatment for canine lymphoma

TTG100 for Canine Cancer

The goal of this clinical trial was to identify a safe dose of TTG100 for dogs with cancer.

Study Outcomes
  • TTG100 was not well tolerated
  • The study was terminated early

LICKing Lymphoma

The goal of this clinical trial was to determine if addition of Valspodar to chemotherapy would lead to sensitization of the cells that are responsible for causing lymphoma in dogs.

Study Outcomes
  • Valspodar was well tolerated
  • Survival time for dogs with diffuse large B cell lymphoma treated with doxorubicin as single agent exceeded historical expectations
  • Valspodar did not appear to sensitize tumor propagating cells to chemotherapy

The SRCBST Family of Trials (SRCBST-1 and SRCBST-2)

The goals of these clinical trials were to identify a biologically active dose of a bispecific ligand targeted toxin (eBAT) and to determine its potential efficacy in dogs with hemangiosarcoma of the spleen eBAT was safe and well tolerated.

Study Outcomes
  • eBAT did not have any of the side effects that are associated with other therapies that attack the same targets
  • Addition of eBAT to the standard of care improved overall survival and increased the proportion of long term survivors
  • eBAT has potential for use in the treatment of human cancer patients Manuscript in press (MCT)

A New Chemotherapy Agent for Dogs with Lymphoma

The goal of this clinical trial was to identify a safe dose of a new chemotherapy agent for dogs with lymphoma. PMID: 22404399

Study Outcomes
  • The therapy was generally well tolerated
  • The therapy showed preliminary antitumor activity in dogs with lymphoma

Targeting CK2 using nanocapsules in feline oral squamous cell carcinoma

The goal of this clinical trial was to identify a safe dose and to determine efficacy of anti-tumor gene therapy delivered using targeted nanocapsules for cats with tumors of the oral cavity.

Study Outcomes
  • The therapy was generally well tolerated
  • The therapy showed preliminary antitumor activity in cats with tumors of the oral cavity

Targeting PI3K in canine lymphoma

The goal of this multi-institutional clinical trial was to determine the effectiveness and safety of a novel targeted drug in dogs with lymphoma

Study Outcomes
  • The trial is no longer enrolling; the results are being analyzed

Long Term Oral Therapy for Osteosarcoma in Dogs

The goal of this multi-institutional clinical trial was to determine if a new multidrug combination would improve survival outcomes for dogs with bone cancer. PMID: 25923466

Study Outcomes
  • Dogs that received additional drug therapy had more side effects than dogs that received only the standard of care
  • The addition of Palladia to treat dogs with bone cancer did not lead to meaningful improvements in survival

Testing to Tailor Tumor Treatment

The primary goal of this multicenter clinical trial was to determine if personalized medicine was feasible in dogs with cancer. In personalized medicine, a variety of tests are performed to determine the specific molecular abnormalities in an individual’s tumor. Knowledge of these abnormalities allows treatment to be tailored to that specific individual. PMID: 2463765

Study Outcomes
  • A consortium of veterinary clinics and laboratories across the country produced personalized medicine reports in less than one week
  • Reports match the specific molecular abnormalities in a tumor to potential therapeutic options
  • In this study, dogs with the same cancer type had different molecular abnormalities, suggesting the need for tailored treatments

Immunotherapy for Lymphoma in Dogs Using Artificial “Immune Cells”

The goals of this clinical trial were to determine the safety, efficacy, and immune response associated with a new immunotherapy treatment in dogs with lymphoma after standard chemotherapy. PMID:21569195

Study Outcomes
  • The treatment was safe
  • Half of treated dogs developed a positive immune response upon receiving the therapy 

Novel Therapeutic Agent for the Treatment of Solid Tumors in Dogs

The goals of this trial were to determine the safety and efficacy of intravenous treatment with a modified bacterium in dogs with solid tumors.

Study Outcomes
  • The treatment was generally well tolerated
  • Significant tumor regression was seen in some dogs

Genetics of Cancer in Companion Animals

The goals of these basic research studies are to understand what causes cancer and what drives its behaviors.

Study Outcomes
  • We have identified genetic markers that are associated with cancer risk in various dog breeds
  • We have developed tests that help us predict the behavior, and thus the likely progression of lymphoma and bone tumors
  • We have improved our understanding of the cells that give rise to hemangiosarcoma and are working to develop tests for early detection
  • We have identified targets for therapy in various cancers
  • We have refined our understanding of how the immune system can be used to fight cancer
  • We are developing new approaches to use vaccines to prevent cancer

Targeted Inhibitors of Aurora Kinases

The goal of this basic research study was to determine if inhibitors of proteins that control cell division, called Aurora kinases, might be highly effective to treat bone cancer. PMID: 23410058

Study Outcomes
  • We found that canine bone cancer cells are very resistant to Aurora kinase inhibitors
  • We concluded that these compounds are unlikely to be useful as single agents to treat bone cancer

Studies of Th17 Cells in Dogs

The goal of this basic research study was to determine if the basic mechanisms of immune responses in dogs resemble those of humans and mice. DOI: 10.3390/vetsci2020043

Study Outcomes
  • We showed that the mechanisms that control generation of inflammatory (T helper type-17) and immunosuppressive (T regulatory) responses in dogs were very similar to those that control comparable human and mouse immune responses 

Immunotherapy for Canine Cancer

The goal of this basic research study was to initiate development of immunotherapy approaches for dog cancer. PMID: 27856424

Study Outcomes
  • We showed that the combination of two immunological treatments is safe in laboratory models of canine lymphoma
  • This combination showed extremely promising results in pre-clinical laboratory studies 

Characterization of Canine NK cells

The goal of this basic research study was to develop methods to isolate and characterize canine natural killer cells. PMID: 23876304

Study Outcomes
  • We developed methods to efficiently isolate canine natural killer cells
  • We showed that the biological traits of these cells in dogs are similar to those of humans and mice 

MicroRNAs in Canine Osteosarcoma

The goal of this basic research study was to identify microRNAs that are potential biomarkers to predict the propensity of canine bone tumors to metastasize.

Study Outcomes
  • We identified a microRNA molecule that seems to be preferentially expressed by bone tumors that have a propensity to metastasize early in the course of disease

Small Animal Medicine

Small Animal Medicine

A multi-institutional study evaluation the diagnostic utility of the spec cPLTM and SNAP®CPLTM in clinical acute pancreatitis in 84 dogs.

Principal Investigator (this site): Jane Armstrong DVM, MS, MBA, DACVIM
This multi-site study examined the diagnostic usefulness (sensitivity and specificity) of the pancreatic lipase blood test and found that these tests have a higher sensitivity than serum amylase or lipase activity in diagnosing clinical acute pancreatitis in dogs.

Publication: McCord K, Morley PS, Armstrong J, Simpson K, Rishniw M, Forman MA, Biller D, Parnell N, Arnell K, Hill S, Avgeris S, Gittelman H, Moore M, Hitt M, Oswald G, Marks S, Burney D, Twedt D. A multi-institutional study evaluation the diagnostic utility of the spec cPLTM and SNAP®CPLTM in clinical acute pancreatitis in 84 dogs. J Vet Intern Med. 2012 Jul-Aug;26(4):888-96.

Treatment of Immune-Mediated Hemolytic Anemia with Individually Adjusted Heparin Dosing in Dogs

Investigators: Sarah Helmond, DVM, David Polzin, DVM, PhD, DACVIM, Jane Armstrong, DVM, MS, MBA, DACVIM

Drs. Sarah Helmond and Maureen Finke (former residents in Internal Medicine) along with Dr. David Polzin, Dr. Jane Armstrong, and Dr. Stephanie Smith (University of Illinois) completed a prospective clinical trial comparing treating dogs with IMHA with individually adjusted doses of heparin to standard of care, fixed low heparin dosing.  Plasma levels were measured using an anti-XA factor assay at Fairview Labs.  The study of 15 dogs found a greater survival rate in the adjusted heparin dosing group than in the group with standard care.

Publication: Helmond SE, Polzin DJ, Armstrong PJ, Finke M, Smith SA.Treatment of Immune-Mediated Hemolytic Anemia with Individually Adjusted Heparin Dosing in Dogs. J Vet Intern Med. 2010 April 6.

Small Animal Surgery

Small Animal Surgery

Comparison of the analgesic efficacy of perioperative firocoxib and tramadol adminstration in dogs undergoing tibial plateau leveling osteotomy

Principal Investigator: Michael Conzemius, DVM, PhD, DACVS

A 30 dog randomized, blinded prospective clinical trial to evaluate the effects of perioperative oral administration of tramadol, firocoxib, and a tramadol-firocoxib combination on signs of pain and limb function after TPLO in dogs. Signs of pain on the short-form Glasgow composite measure pain scale, serum cortisol and limb function on pressure platform gait analysis were measured before and for 3 days after surgery. 

Conclusions and clinical relevance: Dogs that received firocoxib orally, alone or in combination with tramadol, had lower pain scores, lower rescue opiate administration, and greater limb function than dogs that received only tramadol. When used alone, oral administration of tramadol may not provide sufficient analgesic efficacy to treat dogs with pain after orthopedic surgical procedures.

Publication: Davila D, Keeshen TP, Evans RB, Conzemius MG. Comparison of the analgesic efficacy of perioperative firocoxib and tramadol administration in dogs undergoing tibial plateau leveling osteotomyJ Am Vet Med Assoc. 2013 Jul 15;243(2):225-31.

Short-term and long-term outcomes for overweight dogs with cranial cruciate ligament rupture treated surgically or nonsurgically

Principal Investigator: Vicki Wilke, DVM, PhD, DACVS

A prospective, randomized clinical trial of 40 dogs to determine short and long-term rates of successful outcomes of surgical and nonsurgical treatments for overweight dogs with cranial cruciate ligament rupture (CCLR). Dogs received nonsurgical (physical therapy, weight loss and NSAID administration) or surgical (TPLO) treatment groups. Dogs in both groups received the nonsurgical treatments. Dogs were evaluated immediately before and 6, 12, 24 and 52 weeks after initiation of treatments via owner questionnaires, gait analysis, and dual-energy x-ray absorptiometry. 

Results on owner questionnaires indicated dogs in both groups improved in the study, but dogs in the surgical treatment group seemed to have greater improvement. Body fat percentages decreased for dogs in both groups, significantly. Surgical treatment group dogs had a significantly higher peak vertical force for affected limbs vs nonsurgical treatment group dogs at the 24- and 52-week timepoints. Surgical treatment group dogs had a higher probability of a successful outcome vs nonsurgical treatment group dogs.

Conclusions: Overweight dogs with CCLR treated via surgical and nonsurgical methods had better outcomes than dogs treated via nonsurgical methods alone. However, almost two-thirds of the dogs in the nonsurgical treatment group had a successful outcome at the 52-week evaluation time.

Publication: Wucherer KL, Conzemius MG, Evans R, Wilke VL. Short-term and long-term outcomes for overweight dogs with cranial cruciate ligament rupture treated surgically or nonsurgically. J Am Vet Med Assoc. 2013 May 15;242(10):1364-72. doi: 10.2460/javma.242.10.1364. PubMed PMID: 23634680.