Research Consensus Panels
Identifying and Prioritizing Areas for Future Research Trial Development
The Clinical Research Trials Division sponsors Research Consensus Panel (RCP) meetings each year based on topics determined by leadership as the current vital areas of research needs. Those SIR members who wish to lead an RCP respond to a request for applications for the Lead Investigator for a specific RCP topic. The Lead Investigator coordinates a panel of multi-disciplinary subject matter experts in the topic's field of IR medicine. The RCP meeting is a one day meeting where the panelists present on their subtopics and discuss the gaps and future research needs. Audience participants consisting of representatives from industry and federal agencies may contribute to the research discussion. The panel determines two to three top clinical research priority topics that could be developed into a clinical research trial. RCP panelists are then eligible to apply for the Funding Source Development grant which provides seed money for the protocol and or application development of one of the top RCP clinical research priority topics so that they can apply to industry and/or a federal agency for funding for the clinical research trial.
Since 2002, RCP topics have been:
- Interventional Oncology-September 2002 (J Vasc Interv Radiol. 2004 Jan;15(1 Pt 1):7-12.)
- Venous Interventions-October 2004 (J Vasc Interv Radiol. 2005 Dec;16(12):1575-9.; J Vasc Interv Radiol. 2005 Dec;16(12):1567-73.)
- Uterine Artey Embolization (UAE)-March 2005 (J Vasc Interv Radiol. 2006 Dec;17(12):1871-9.)
- Skeletal Interventions-September 2005 (J Vasc Interv Radiol. 2008 May;19(5):631-8.)
- Lung Oncology-April 2006
- Liver Oncology-March 2006
- Cardiovascular Imaging-October 2006
- Inferior Vena Cava (IVC)-June 2007 (J Vasc Interv Radiol. 2009 Jun;20(6):697-707.)
- Peripheral Arterial Disease-April 2008 (pending submission)
- Renal Ablation (Oncology)- April 2010 ((J Vasc Interv Radiol. 2010 Dec; 21: 1807-1816)
- Interventional Endovascular Management of Chronic Cerebrospinal Venous Insufficiency in Patients with Multiple Sclerosis- October 2010 ((J Vasc Interv Radiol. 2011 May;22: 587-593)
- Optimizing Radiation Use During Fluoroscopic Procedures-October 2010 (J Vasc Interv Radiol. 2011 April; 22 (4): 425-429)
- Management of Metastatic Colorectal Cancer- October 2011; Journal of Vasc. and Interv. Radiol Vol. 23, Issue 2, Pages 153-163
- Management of Critical Limb Ischemia, May 2012, Journal of Vasc. Interventional Radiology 2013, April; 24: 451-458.
- Prostatic Artery Embolization for Treatment of Benign Prostatic Hyperplasia (BPH), March 2013
- Minimally-Invasive Sympathetic Denervation: Expanding Applications Indications and Techniques, October 2013
- The Development of IR Performance Measures, June 2014
- Critical Issues in Chronic Central Venous Access and Pathways for Investigation RCP, October 2014
The Development of IR Performance Measures
Critical Issues in Chronic Central Venous Access and Pathways for Investigation RCP
Minimally-Invasive Sympathetic Denervation: Expanding Applications Indications and Techniques
On Oct. 21, 2013 the SIR Foundation sponsored their fall research consensus panel meeting (RCP). The RCP topic was "Minimally-invasive Sympathetic Denervation: Expanding Applications Indications and Techniques." John F. Angle, M.D., FSIR, division of interventional radiology, University of Virginia Health System was the lead investigator and Kamran Ahrar, M.D., FSIR, SIR Foundation Clinical Research Trials Division Chair, moderated the discussion. The multidisciplinary panel was comprised of physiologists, cardiologists, IRs, and a nephrologist, and audience attendance included representatives from industry and government agencies.
An important research priority for clinical study of sympathetic renal denervation was defined by the research consensus panel. The clinical applications of renal denervation (RDN) have progressed rapidly without a thorough understanding of the mechanism of action or a reliable way to assess the changes in efferent sympathetic signaling in the kidney. This physiologic understanding will be important in determining who will benefit from this procedure and how durable the results of the procedure are. The panel's consensus for a future study was determined as, "MRI measurement of renal perfusion and vascular resistance before and after renal sympathetic denervation." The study hypothesis will be that the change in renovascular resistance is a major predictor of response to renal denervation in controlling hypertension (HTN). The primary specific aim will be to determine if MRI can provide a measure of renovascular resistance before RDN that can predict successful outcomes in patients with HTN. Secondary specific aims will be: to validate the MRI resistance and perfusion measurements, image the brain for changes in afferent signaling from the kidney, and correlate the frequency of arrhythmias with changes in renal resistance.
The panel also determined that pre-clinical studies of denervation in the liver, pancreas and bowel should be an important initiative for interventional radiology research given our background in visceral angiography, celiac plexus ablation and the clinical diagnosis and management of gastrointestinal neuro-vascular diseases.
Prostatic Artery Embolization for Treatment of Benign Prostatic Hyperplasia (BPH)
The multidisciplinary research consensus panel was comprised of experts on the topic of Prostatic Artery Embolization for Treatment of Benign Prostatic Hyperplasia (BPH), and the lead investigator was Jafar Golzarian, M.D., Professor of Radiology and Surgery, Director, Division of Interventional, Radiology & Vascular Imaging, Malcolm B. Hanson Chair in Radiology, University of Minnesota. Dr. Kamran Ahrar, SIR Foundation Clinical Research Trials Division Chair moderated the panel. Panelists included, IRs, radiologists and urologists from the U.S., Brazil and Portugal. Dr. Kamran Ahrar (IR)- Moderator; Dr. Jafar Golzarian (IR)- Lead Investigator; Dr. J Kellogg Parsons (Urologist), Dr. Kevin McVary (Urologist), Dr. Tiago Bilhim (IR), Dr. Jafar Golzarian (IR), Dr, Joao-Martins Pisco (IR), Dr. Francisco Cesar Carnevale (IR), Dr Alberto A Antunes (Urologist), Dr. James Spies (IR), Dr. Neil Wasserman (Radiologist), Dr. B. Konety (Urologist), Dr. David N. Siegel (IR).
The top research priority topic for further study was determined by consensus of the panel to be: Title: A prospective randomized multicenter clinical research study to determine safety and effectiveness of PAE, with the primary objectives as: 1. To evaluate the safety and feasibility of PAE for BPH in the first phase of the study, 2. To evaluate the effectiveness of PAE versus a sham procedure using IPSS score as the primary endpoint. The study's secondary objective is to evaluate QOL.
Management of Critical Limb Ischemia
This research consensus panel's lead investigator was Sanjay Misra, MD, FSIR, Associate Professor of Radiology, Surgery, and Cardiology, Mayo Clinic, College of Medicine, and the moderator was SIR Foundation's Vice Chair, Stephen Kee, MD, FSIR. The panel was comprised of interdisciplinary subject matter experts representing IR, Vascular, Cardiology and Interventional Cardiology, and Internal Medicine. Panelists included: Dr. Michael Conte (Vascular Medicine), Dr. Patrick Geraghty (Vascular Medicine), Dr. William Hiatt (Internal Medicine), Dr. Alan Hirsch (Cardiologist), Dr. Michael Ritt Jaff, DO (Vascular Medicine), Dr. Robert Lookstein (IR), Dr. Manesh Patel (Cardiologist, IC), Dr. Ken Rosenfield (Vascular Medicine), Dr. John Runback (IR), Dr. Christopher White (Cardiologist, IC). Audience participants from government agencies and corporate entities with an interest in this topic attended. The panel presented on the current research for critical limb ischemia, and began discussing the protocol development for an endovascular trial on CLI.
Management of Metastatic Colorectal Cancer
The panel was moderated by Stephen Kee, MD, FSIR, (IR), Chair of the SIRF Clinical Research Trials Division. Bertrand Janne d'Othee, MD, MPH, FSIR,(IR) was the RCP lead investigator. Panelists included Alan Venook, MD, (medical oncologist); Nader Hanna, MD, FACS , FICS, (surgical oncologist); Jean-Nicolas Vauthey, MD, (surgical oncologist); Constantinos T. Sofocleous, MD, PhD, FSIR, (IR) (Dr. Sophocleous also presented on behalf of Nancy E. Kemeny, MD,( medical oncologist); Steven Cohen, MD, (medical oncologist); Michael C. Soulen, MD, FSIR, (IR); J.F. (Jeff) Geschwind, MD, FSIR, (IR); Matthew S. Johnson, MD, FSIR, (IR); Robert J. Lewandowski, MD, (IR); Andrew Kennedy, MD, FACRO, (radiation oncologist); Ravi Murthy, MD, (IR).
The panel's final consensus on the top clinical research priorities were: 1. Studies to evaluate the benefit of combining new imaging criteria with FNA +/- biopsy AND establish new or modified disease status criteria (EASL/RECIST)). 2. studies enrolling selected subsets of patients (eg, KRAS mutants) to SIRT, RFA or both.
- Renal Ablation (IO)
Renal Ablation (Oncology) Protocol Development
On Monday, April 26, 2010 the Renal Ablation Research Consensus Panel meeting convened in Northern Virginia. SIR Foundation Clinical Research Trials Division Chair, Dr. Stephen Kee served as moderator. The RCP Lead Investigator was SIR member Christos Georgiades, M.D., Ph.D., Associate Professor of Radiology & Surgery, Clinical Director, Vascular & Interventional Radiology, Johns Hopkins Hospital. He had organized a multidisciplinary panel of subject matter experts in the field of renal ablation. They presented on topics of renal ablation oncology and then discussed and determined top clinical and registry research priority topics that need further research. The clinical topics are: 1. A randomized trial looking at small tumors, < 4cm in size, surveillance versus ablation (age cut-off), 2. A prospective trial on safety and effectiveness of ablation at 5 years in biopsy proven cancer, and 3. Use QOL measures to determine procedural benefit for ablation versus surveillance versus surgery. Panelists are encouraged to apply for the Foundation's Funding Source Development Grant which provides seed money for an investigator to draft a clinical research trial protocol and/or application on one of the top RCP clinical research priority topics to submit to a federal and/or industry sponsor for funding.
Research priorities that are well suited to registry based data collection were also discussed. Priority areas identified by the panel include:: 1. A limited registry looking at specific narrow questions, tumors < 4cm, ablation only, 2. Use a registry to collect data for PQRI reasons, get survival data also, 3. A registry to determine best practice for follow-up imaging, post-procedure biopsy, and 4. A registry to determine which patients need to be treated, risk factors versus outcomes.
The panelists who participated in the Renal Ablation RCP: Kamran Ahrar, MD (IR), Thomas D. Atwell, MD (IR), Jeffrey Caddedu, MD (Urology), Jeremy C. Durack, M.D., M.S. (IR), Constantine E. Frangakis, PhD (Biostatistics), Debra A. Gervais, MD, (IR), Hans-Joerg Hammers, MD, PhD (Medical Oncology), Raymond Leveillee, MD, FRCS-G (Urology), Peter J. Littrup, M.D (IR), Maxwell Meng, MD (Urology), Steve Raman, MD (IR), Ronald Rodriguez, M.D., Ph.D. (Urology), and Ronald J. Zagoria, MD, FACR-G (IR).
Interventional Endovascular Management of Chronic Cerebrospinal Venous Insufficiency in Patients with Multiple Sclerosis
The Interventional Endovascular Management of CCSVI in Patients with MS
Research Consensus Panel was convened on October 18, 2010 in Herndon,
Va. moderated by Dr. Gordon McLennan, and the co-lead investigators
were interventional radiologists and SIR members Dr. Ziv Haskal and Dr.
Gary Siskin. Panelists were from the following disciplines: IR,
neurology, cardiovascular thoracic surgery, research science and
The following presentations were delivered:
Multiple Sclerosis Overview: Classification, Clinical Presentation, Treatment Strategies, Walter Royal, MD
Venous Disease and Multiple Sclerosis, Michael Dake, MD
The Role of Doppler Ultrasound in the Diagnosis of CCSVI, Sandy McDonald, MD
The Role of Magnetic Resonance Venography in the Diagnosis of CCSVI, Mark Haacke, PhD
Venous Angioplasty for CCSVI: Technique and Image Interpretation, Ziv Haskal, MD,
CCSVI Literature Review,Gary Siskin, MD
The complete panel included: R. Torrance Andrews, MD, FSIR, (IR); Michael D. Dake, MD, (IR); E. Mark Haacke, PhD, (Physicist); Ziv J. Haskal, MD, FSIR, FAHA, FACR, FCIRSE; David Hubbard, MD, (Neurologist); Gordon McLennan, MD, FSIR, SIR Foundation Chair; Sandy McDonald, MD, (Cardiovascular Thoracic Surgeon); Walter Royal, III, MD, (Neurologist); Heidi A. Sauder, Ph.D. (Researcher); Salvatore Sclafani, MD, FSIR, (IR); Gary P. Siskin, MD, FSIR; Suresh Vedantham MD, FSIR (IR).
Audience included representatives from five industries: Abbott, Boston Scientific, CR Bard, Cook, WL Gore. NIH representatives were from NINDS and the Magnuson Clinical Center.
Optimizing Radiation Use During Fluoroscopic Procedures
The Optimizing Radiation Use During Fluoroscopic Procedures Research
Consensus Panel convened on October 25, 2010 in Herndon, Va. moderated
by Dr. Stephen Kee, and the lead investigator was IR and SIR member,
Dr. James Duncan. Dr. Duncan coordinated a panel consisting of
multi-disciplines, IR, imaging, and registry expertise.
The following presentations were delivered:
Improving healthcare - Radiation use as a priority, Gary Becker, MD
Improving CT - Image Wisely, Jim Brink
Children as a Priority - Image Gently, Dorothy Bulas, MD
Data Driven Improvement - ACR Registries, Mythreyi Chatfield, PhD
Improving tools for healthcare- Role of FDA, Simon Choi, PhD;
Improving healthcare processes - Role of AHRQ, Jeff Brady, MD, MPH
Data and system-based approaches to optimizing performance during fluoroscopic procedures, Joey Steele, MD
Collecting and analyzing data on radiation use during fluoroscopic procedures, Don Miller, MD
DICOM-SR- New format for reporting radiation use during fluoroscopic procedures, Steve Balter, MD (IR
Summary of current state, Jim Duncan, MD, PhD (IR).
The complete panel included: Stephen Balter, MD, PhD, (IR); Gary J. Becker, MD, (IR); Mythreyi Bhargavan Chatfield, PhD, (ACR); Jeff Brady, MD, MPH, (AHRQ); James A. Brink, MD. F.A.C.R., (IR, "Image Wisely"); Dorothy I. Bulas MD, (Diagnostic Imaging and Radiology, "Image Gently"); Simon T. Choi, PhD, MPH, (FDA); James R. Duncan, MD, PhD, FSIR; Stephen Kee, MD, FSIR; Donald L. Miller, MD, FSIR FACR (IR); Joseph R. Steele, MD, (IR); Bairbre L. Connolly, MD, (IR); Robert Dixon, MD (IR); Joel Gray, PhD, (Physicist); Donald W. Robinson, LTC, MC FS DMO, (DOD); Mark Sands, MD. (IR); Mandie Street, RT,(R)(MR); David A. Schauer, ScD, CHP (NCRP), Raymond Thornton, MD (IR), Robert A. Wise, MD, (The Joint Commission).
PAD Protocol Development
Peripheral arterial disease (PAD) expert panelists convened Sept. 4 in Herndon, Va., to map out the protocol of a high-level consortium outcomes study to evaluate SFA disease outcomes. The protocol topic was determined by research priorities and the recommendations from the April 2008 PAD Research Consensus Panel meeting, where panelists presented on different areas of PAD research, discussed areas that were in need of further investigation, and prioritized and scored the suggested clinical topics. Using a modified NIH scoring system, the outcomes study received the highest number of votes, followed by an imaging plaque trial. The goals of the meeting were to discuss the basis for a longitudinal study of interventions and to establish the general constructs of the study. Additionally, the expert panelists reviewed data collection design, including electronic data capture elements, and created parameters for population size and data analysis. Panelists also discussed strategies on governance, publications and funding policies.
The PAD outcomes study will represent a broad, multiyear survey of the current and future practice of endovascular therapy for SFA disease and the factors influencing current trends. Additionally, the study will serve to provide long-term data in the PAD population undergoing various interventions. The primary goal of the outcomes study is to conduct a prospective, multicenter, observational study to characterize factors influencing acute and long-term outcomes in endovascular intervention for stenotic/occlusive atherosclerotic disease in the superficial femoral and popliteal artery for all currently employed and potential future devices. During the next steps of the outcomes study development, panelists will finalize the study design and protocol.