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OUR MISSION
The mission of the University of Virginia Core Lab and Clinical Over Read Service (UVA CORS) is to promote advances in cardiovascular medicine and healthcare by providing an organized and unbiased expert analysis of imaging studies used for clinical research trials.
CONTRIBUTIONS TO CARDIOVASCULAR MEDICINE
The University of Virginia Division of Angiography and Interventional Radiology enjoys a long history of leadership in the field of vascular diagnosis and treatment. Since 1978, when Dr. Charles J. Tegtmeyer performed the first percutaneous transluminal renal angioplasty (PTRA) in the United States, he and his Divisional colleagues have been recognized as pioneers, developers, and leaders in the diagnosis and treatment of vascular disease. The Division continues to be actively involved in the clinical advancement of endovascular therapy and has a broad range of experience and expertise in vascular imaging.
UVA CORS SERVICE
The University of Virginia Core Lab and Clinical Over Read Service provides a gamut of services which include:
- trial design and development
- preparation of standard operating manuals
- preparation of Study Manuals for clinical sites
- management and tracking of data in compliance with FDA regulations
- quality assurance and problem resolution
- computerized quantitative analysis
- unbiased, expert analysis of vascular imaging studies
Our goal is to provide a high quality and timely service tailored to meet the needs of both the trial and govermental regulations.
Trial design and development
Trial design and development involves a review of the study protocol, study clinical indication, and a review of the scientific literature to develop documents necessary for study conduct. In collaboration with the Sponsor, UVA CORS develops written Imaging and Interpretation Protocols and case report forms for each study. The Imaging Protocol provides a standard method for acquiring the data for analysis, while the Interpretation Protocol provides a standard method for review of the imaging studies. Lastly, UVA CORS also develops a Manual of Operations for each trial for which it provides core lab services.
Preparation of Study Manual for sites
UVA CORS writes and distributes Study Manuals to the clinical investigative sites. Items in the Study Manual include: Imaging Protocol/s, Study Submission Protocol, Study Management, and Training. Additionally, UVA CORS is involved in protocol compliance and training of sites at Investigators’ meetings.
Data managment and tracking
In addition to storing and retaining all submitted imaging studies in accordance with FDA guidelines, UVA CORS develops and maintains a relational database for each trial with which it is involved. Case management data points and interpretation results are tracked and maintained. Image interpretation data are submitted to the Sponsor in an organized and timely manner. Lastly, we can serve as a data coordinating center, preparing quantitative and qualitative reports as well as statistical analysis.
Quality Assurance
UVA CORS has established quality assurance measures in two realms: conduct of clinical trials and insuring a consistent high standard to the UVA CORS services.
Our focus with clinical trials is to proactively encourage compliance with Imaging Protocols at the investigative sites through education and site training. Each imaging study submitted is reviewed for compliance to imaging and submission protocols prior to review by a UVA CORS physician. Non-compliance is communicated through standardized analysis forms. Monitoring of imaging and submission protocol compliance is communicated to the study Sponsor through standardized Quantitative and Qualitative Monitoring Reports.
In addition to regular equipment monitoring, UVA CORS performs on-going evaluation for both intra- and inter-reader variability with imaging interpretation and database accuracy.
UVA CORS CURRENT and FUTURE TRIALS include:
* Medtronic Vascular ® Phase II AneuRx Abdominal Aortic Aneurysm Stent Graft Trial
* Medtronic Vascular ® Phase II Aorto-Uni-Iliac Stent Graft Trial
* Medtronic Vascular® Thoracic Aortic Aneurysm Stent Graft Trial – The VALOR Trial
* NIH sponsored Cardiovascular Outcomes in Renal Atherosclerotic Lesions (CORAL)
FACILITIES
UVA CORS is located on the second floor of the Multistory building of the University of Virginia Health System and offers a state-of-the-art facility utilizing the resources of the University of Virginia Computing Information and Communication system.
UVA CORS PERSONNEL
Medical Director: David J. Spinosa, MD
Associate Professor of Radiology at the University of Virginia School of Medicine, Dr. Spinosa assumed the Directorship of UVA CORS in February, 2001. Along with his divisional colleagues, he has participated in multiple clinical trials. His research interests include arterial revascularization, development of alternative contrast agents for interventional radiology, and the development of computerized quantitative analysis software for arterial vessels. In addition, Dr. Spinosa has authored numerous scientific publications, including journal articles, abstracts, and textbook chapters.
UVA CORS Coordinator: Mary Baldwin, BA
With 10 years of experience in clinical trial coordination, including UVa Consortium coordinator for the NCI sponsored RDOG-V trial, Ms. Baldwin has demonstrated abilities in the administrative and operational requirements of multi-centered, complex clinical trials.
Interpreting Physicians
* Alan H. Matsumoto, MD
Professor of Radiology at the University of Virginia School of Medicine and Director of the Division of Angiography and Interventional Radiology, Dr. Matsumoto served as Director of UVA CORS from its inception in 1997 until 2001. His research interests include renal
vascular disease and treatment of aortic aneurysm disease; his current research studies include PTA and stenting of chronic mesenteric ischemia and PTA and stenting in the treatment of subclavian and brachiocephalic stenosis. Additonally, Dr. Matsumoto serves on
numerous Editorial and Advisory boards and has authored multiple scientific publications including journal articles, abstracts, and textbook chapters.
* John “Fritz” Angle, MD
Associate Professor of Radiology at the University of Virginia School of Medicine, Dr. Angle’s research interests include biliary interventions and venous access. He is currently participating in protocols studying clearing clotted tunneled dialysis catheters and the use of beta radiation as well as a comparative analysis of common techniques for preserving central venous access. In addition, Dr. Angle has has authored several scientific publications including journal articles, abstracts, and textbook chapters.
* Klaus D. Hagspiel, MD
Associate Professor of Radiology at the University of Virginia School of Medicine, Dr. Hagspiel’s research interests include development of non-invasive imaging modalities and use of hyperpolarized gases. His current MRI trials include Investigational MRI/Spectroscopy, MRI Evaluation of Patients with Vascular Malformations and Efficacy of MR Venography. In addition, he is serving as Principal Investigator in a Phase III Multicenter Study studying PAOD with CTA. Dr. Hagspiel has has authored several scientific publications including journal articles, abstracts, and textbook chapters.
* Daniel A. Leung, MD
Assistant Professor of Radiology at the University of Virginia School of Medicine, Dr. Leung’s primary research interest is hepato-biliary interventions; his current protocols in that area include TheraSphere Yttrium-90 Glass Microspheres and Islet Cell Transplantation in Patients with Type I Diabetes. Additionally, he has authored several scientific publications including journal articles, abstracts, and textbook chapters.
Information Technology: Gary D. Hartwell, DSc.
Dr. Hartwell brings over 30 years of experience as a diagnostic physicist to his role as Director of Information Technology for UVA CORS. He has authored numerous publications including journal articles, abstracts, and textbook chapters and is recognized internationally in the field of radiation physics.
Biostatistics: Eric A. Bissonette, MS
Mark R. Conaway, Ph.D.
Members of the University of Virginia Department of Health Evaluation Sciences, Mr. Bissonette and Dr. Conaway provide statistical services to UVA CORS. Their services include support for grant preparation, study design, protocol development, data analysis, randomization and manuscript preparation.
To explore how UVA CORS can meet your Core Lab needs, contact:
Mary Baldwin, BA David J. Spinosa, MD
P.O. Box 800170 P.O. Box 800170
Charlottesville, VA 22908 Charlottesville, VA 22908
Phone: 434.982.2572 Phone: 434.924.9401
E-mail: mb2b@virginia.edu E-mail: djs4m@virginia.edu
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