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

Minimally invasive per-catheter patent ductus arteriosus occlusion in dogs using a prototype duct occluder

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. PMID: 18289299

Study Outcomes
  • Successful placement of the Amplatz Canine Duct Occluder was acheived in all 18 dogs
  • Complete occlusion was confirmed in 17/18 dogs during the procedure, at 1 day and 3 months post-procedure
  • 12/13 dogs had complete occlusion 12 months or more post-procedure<--break->

 

Patent ductus arteriosus occlusion in small dogs utilizing a low profile Amplatz® canine duct occluder prototype

The goal of this study was to develop procedures and assess the safety, utility and effectiveness of a low profile Amplatz canine duct occluder (ACDO) prototype for dogs considered too small for currently available danine duct occluders. PMID: 26363940

Study Outcomes
  • 21 dogs received successful ductal occlusion wtih no perioperative complications or device embolization
  • Of the dogs (17/21) that returned for long term follow up, all had complete ductal occlusion on echocardiography
  • The low profile ACDO is a safe and effective method of PDA occlusion in the small dog

 

Dermatology

Dermatology

Canine skin microbiome studies

The primary aims for this study were to evaluate whether or not there is a core bacterial community living on the skin of healthy domestic dogs from Minnesota and if body site, dog cohabitation and seasonality have an impact on this community. PMID: 28289569

Study Outcomes
  • The canine skin bacterial community is highly diverse and highly variable
  • No significant differences seen in overall bacterial community structure between the three skin sites
  • Significant differences when samples grouped by timepoint
  • Dogs which live together have significantly more similar bacterial communities than dogs not living together

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

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. PMID: 24581322

Study Outcomes
  • Significant differences seen at all study timepoints (days 1, 2, 7, 14, 28)
  • Apoquel® is now available as a prescription medication for dogs

Long-term compassionate use of oclacitinib in dogs with atopic and allergic skin disease: safety, efficacy and quality of life

This study assessed long-term safety, efficacy and quality of life of oclacitinib-treated dogs enrolled in a compassionate use protocol. Dogs had previously received oclacitinib in a clinical trial. PMID: 25688708

Study Outcomes
  • Dogs showed >=50% reduction in pruritis in 64% of cases, and same reduction in dermatitis in 66% of cases
  • Owners saw a positive quality of life in >90% of dogs
  • Hematology and clinical chemistry remained in normal ranges; side effects included urinary tract infection/cycstitis, vomiting, otitis, pyoderma and diarrhea
  • Study concluded that oclacitinib was safe and efficacious for long-term use and improved the quality of life for dogs in this study

A blinded, randomized, placebo-controlled, dose determination trial of lokivetmab (ZTS-00103289), a caninized, anti-canine IL-31 monoclonal antibody in client owned dogs with atopic dermatitis

The goal of this study was to compare three doses and describe the dose response of lokivetmab in dogs with atopic dermatitis (AD). Dogs were assessed for pruritus by owners and the Canine AD Extent and Severity Index (CADESI-03) tool was used by clinicians. PMID: 27647513

Study Outcomes
  • Lokivetmab at 0.5 and 2.0 mg/kg reduced pruritus compared to placebo for at least one month
  • Further studies were needed to better understand variability among dogs in a broader population of dogs with AD

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

The purpose of this study was to investigate the efficacy of imiquimod 5% cream in the treatment of equine aural plaques. PMID: 20500494

Study Outcomes
  • Complete resolution of lesions was noted in all horses immediately post-treatment and long-term resolution was 88%
  • All horses were followed for 12-22 months and only two horses had a recurrence of lesions in that time
  • Topical application of imiquimod 5% cream is an efficacious treatment for aural plaque in horses

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

The purpose of this study was to evaluate imiquimod 5% cream, an immune response modifier with potent antiviral and antitumor activity, as a topical treatment of equine sarcoids. PMID: 16827669

Study Outcomes
  • Results showed 12/15 lesions reduced in size by >75%, and 9 resolved completely
  • Results suggest that topical imiquimod is a therapeutic option for the treatment of equine sarcoids

Instructional links

Aldara Frequently asked questions for Owners

Veterinarian Instructions for use of Aldara®(imiquimod)

Neurology

Neurology

Intravenous Topiramate: Pharmacokinetics in Dogs with Naturally Occurring Epilepsy

The goals of this study were to characterize the pharmacokinetics of intravenous dose of topiramate in dogs with naturally occurring epilepsy. PMID: 27995128

Study Outcomes
  • IV topiramate has a relatively rapid onset of action
  • Dogs on phenobarbital maintenance therapy required a higher dose to reach target concentration
  • Topiramate is a good candidate for further evaluation for seizure emergencies in dogs and people

Canine status epilepticus treated with fosphenytoin: A proof of principle study

Epilepsy and canine status epilepticus occur naturally in dogs with similar prevalence, presentation and percentage of refractory cases as human epilepsy. The goal of this study was to determine if canine status epilepticus treated with fosphenytoin (FOS) results in a similar responder rate as for people. PMID: 25953073

Study Outcomes
  • FOS is tolerated and effective in canine status epilepticus at plasma phenytoin levels which are clinically relevant for human status epilepticus
  • Naturally occurring canine status epilepticus can be used as a translational plaform for future studies of novel compounds for status epilepticus

 Canine Epilepsy Network

Visit the Canine Epilepsy Network website.

Oncology

Oncology

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 has potential for use in the treatment of human cancer patients (MCT). PMID: 28193671
      • eBAT did 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
      • See poster presented at American Association of Cancer Research

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. PMID: 28357033

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

 

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. PMID: 28335614

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: 24637659

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

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

Long-term outcome of an intra-articular allograft technique for treatment of spontaneous cranial cruciate ligament rupture in the dog

The goal of this study was to determine the 12-month outcome in dogs with spontaneous cranial cruciate ligament (CCL) rupture with an intra-articular decelluarized allograft. Dogs were evaluated with an owner questionnaire, radiographs, and force platform gait analysis before and 2, 6, and 12 months after surgery. PMID: 28370152

Study Outcomes
  • Intra-articular repair using a decellularized allograft can provide functional clinical outcomes in dogs with CCL disease as evidenced by owners reporting improvement in level of pain and mobility especially over the first 6 months and peak vertical force and vertical impulse improved across all time points
  • Ground reaction force asymmetry index for peak vertical force and vertical impulse results varied
  • Osteoarthritis scoring did not change over the 12-month period and some femoral-tibial translation was detected on standing horizontal beam radiographs
  • A better understanding of long-term engraftment after this procedure is needed

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

The goal of this study was to compare the analgesic efficacy of perioperative firocoxib and tramadol adminstration in dogs undergoing tibial plateau leveling osteotomy (TPLO). Firocoxib and tramadol were examined alone and in combination. PMID: 23822079

Study Outcomes
  • 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

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

The goal of this study was to determine short- and long-term rates of successful outcomes of surgical and nonsurgical treatments for overweight dogs with cranial cruciate ligament rupture (CCLR). A successful outcome was defined as an affected limb net ground reaction force > 85% of the value for healthy dogs and a ≥ 10% improvement in values of questionnaire variables. PMID: 23634680

Study Outcomes
  • Overweight dogs with CCLR treated via surgical and nonsurgical methods had better outcomes than dogs treated via nonsurgical methods alone
  • Surgical treatment group dogs had a higher probability of a successful outcome vs nonsurgical treatment group dogs
  • Almost two-thirds of the dogs in the nonsurgical treatment group had a successful outcome at one year