Radiology Clinical Trials
The following is a partial self-reported listing of research projects headed by our radiology faculty. Involvement by trainees is desired and actively promoted. Some of the listed projects are active and on-going, while others are in their preliminary phase to opening at UCH. There is also a list of previous studies that our faculty have been involved with in the past. Please feel free to contact our research coordinator with any questions regarding these projects.
20-2933 - Instylla HES™ Hypervascular Tumor Pivotal Study Sponsor Protocol No. INY-P-20-001, Rev E WIRB Protocol No. 20202475
PI: Gordon McLennan, MD
Description: The purpose of this study is to evaluate the ability of Instylla HES to effectively embolize targeted arterial segments of hypervascular tumors along with standard of care (SOC) transarterial embolization/conventional transarterial chemoembolization. These evaluations will result in an assessment of the acceptable risk of device and procedure-related serious adverse events for the Instylla HES.
For more information, please visit https://clinicaltrials.gov/ct2/show/NCT04523350
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20-0522 - ClotTriever Outcomes (CLOUT) Registry Sponsor Protocol No. 18-001 WIRB Protocol No. 20181579
PI: Johnathan Lindquist, MD
Description: The purpose of CLOUT is to collect a registry and evaluate patient outcomes after the treatment of acute and non-acute lower extremity deep venous thrombosis (DVT). Using the ClotTriever Thrombectomy System, patients will be treated, and their outcome will be documented in a registry to help advance the efficiency of lower extremity clot removal.
For more information, please https://www.inarimedical.com/clout/
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20-2593 - The Biological Allograft Chain Tissue Implant & Associated Manual Surgical Instrumentation: A Prospective, Post-Market Study Sponsor Protocol No. SP-18-001 WIRB Protocol No. 20181956
PI: Corey Ho, MD
Description: The purpose of Lenoss is to evaluate the efficiency of the Biological Allograft Chain tissue. Through the evaluation of fracture stability, assessed through patient reports of pain over time, the Biological Allograft Chain tissue product will be tested for bone void filling applications. Pain will be assessed using the Visual Analog Scale (VAS) – Back Pain.
For more information, please https://clinicaltrials.gov/ct2/show/NCT04064710
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20-1867 - Study to assess the improvement in detection accuracy for lung nodules when aiding radiological exams with computer vision technology
PI: Daniel Vargas, MD
Description: The purpose of this study is to test the VisiRad XR software’s effectiveness with aiding radiologist in lung nodule detection accuracy. The participants will be radiologists that are randomly assigned to one of two arms. Those in the aided arm will look at chest radiographs using the VisiRad XR software, whereas those in the unaided will not. The two arms will be used to compare the accuracy of interpreting radiologist as they read these chest radiographs.
For more information, please visit https://imidex.com/solutions/
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18-1660 - VISION: AN INTERNATIONAL, PROSPECTIVE, OPEN-LABEL, MULTICENTER, RANDOMIZED PHASE 3 STUDY OF 177LU-PSMA-617 IN THE TREATMENT OF PATIENTS WITH PROGRESSIVE PSMA-POSITIVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC)
PI: Bennet Chin, MD
Description: The purpose of VISION is to test the effectiveness of 177Lu-PSMA-617 on patients with progressive PSMA-positive mCRPC. This will be done by comparing the (OS) overall survival in patients with progressive PSMA-positive mCRPC who receive 177Lu-PSMA-617 and best supportive/best standard of care, versus those who just receive best supportive/best standard of care. Patients will be randomly assigned to either arm of the study to understand the utility of 177Lu-PSMA-617.
For more information, please visit https://clinicaltrials.gov/ct2/show/NCT03511664
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20-2502 - Computer-Aided Management of Unruptured Intracranial Aneurysms
PI: Vincent Timpone, MD
The purpose of this study is to analyze retrospective patient data to determine the sensitivity and specificity of the Surgical Preview software. The retrospective data will be processed by the SurgicalPreview software to measure its effectiveness in detecting unruptured intracranial saccular aneurysms in the Circle of Willis (COW) and Posterior circulation (PICA/SCA).
For more information, please visit https://www.rapidai.com/rapid-aneurysm
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18-1505 - Review of IVC Filter Practice Patterns
PI: Johnathan Lindquist, MD
The purpose of this study is to retrospectively evaluate clinical outcomes, practice patterns, and risk factors specific to different patients. This study looks at both inpatients and outpatients who have had IVC filters placed or retrieved. The main interest is to compare the filters and filter retrieval devices and their outcomes within UCH. Over 25 years of retrospective data will be evaluated and used to document adjunctive/advanced retrieval techniques, implanting factors on filter duration, and filter placement/retrieval complications.
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18-0392 - Tomosynthesis Mammographic Imaging Screening Trial (TMIST)
PI: Dulcy Wolverton, MD
The purpose of TMIST is to determine whether tomosynthesis (TM) can or should replace digital mammography (DM) to screen for breast cancer. Healthy female patients are randomly assigned to either the 2D screening (DM) arm or the 3D screening (TM) arm over the course of 5 years, with an additional 3 years of follow up, to determine the effectiveness of the technology. If it is determined that tomosynthesis is more effective in finding important breast cancers, i.e., those that are more likely to advance and kill women, then those in the (TM) arm will see a decrease in these cancers compared to the (DM) arm. This study will look at the utility of the different screening tools as well as the advantages and disadvantages of each screening method.
For more information about this trial, please visit https://ecog-acrin.org/tmist
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If you are a patient interested in finding out more about any of these studies, please contact our Radiology Clinical Research Coordinator.
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If you are a patient interested in finding out more about any of these studies, please contact our Radiology Clinical Research Coordinator.
16-0812: Radiation-Emitting SIR-Spheres in Non-resectable (RESIN) Liver Tumor Patient Registry
PI: Robert Ryu, MD
The purpose of the RESiN registry is to collect information about patients who have primary and secondary liver cancer receiving SIR-Spheres as part of their overall oncologic management. SIR-Spheres is a medical device containing Yttrium-90 (Y-90), a radioactive material that has been used to shrink liver tumors. The RESiN registry will collect information including: patient demographics (sex, age, race/ethnicity); previous, concurrent and follow-up oncologic treatments; details of Y-90 treatment; and outcomes and complications.
The information generated will help doctors better understand treatment patterns involving Y-90 therapy and gain insight in the long-term outcomes for patients. It will also guide future research for using Y-90 therapy, especially for those conditions where data are currently limited.
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15-0743: Prospective Study of Magnetic Resonance Imaging (MRI) and Multiparameter Gene Expression Assay in Ductal Carcinoma In Situ (DCIS)
PI: Wei Shin Wang, MD
The purpose of this study is to evaluate advanced imaging to more accurately identify the anatomic extent of the disease with molecular characteristics of Ductal carcinoma in situ (DCIS) and to more accurately characterize the biology of the disease rather than just the symptoms and pathology of the disease. Ductal carcinoma in situ (DCIS) is a non-invasive cancer where abnormal cells have been found in the lining of the breast milk duct. The atypical cells have not spread outside of the ducts into the surrounding breast tissue. This integrated anatomical and biological characterization from the Magnetic Imaging Resonance (MRI) of DCIS lesions is expected to better stratify the need for therapeutic interventions, while maintaining excellent clinical outcomes, facilitating more informed shared decision making, and preserving quality of life.
For more information about this trial, please visit http://ecog-acrin.org/clinical-trials/e4112-educational-materials or www.clinicaltrials.gov NCT number: NCT02352883
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14-2053: Clinical Validation of a Predictive Model for the Presence of Cervical Lymph Node Metastasis in Papillary Thyroid Cancer
The purpose of this study is to compare the accuracy of two methods of lymph node evaluation using ultrasound in patients who have papillary thyroid cancer (PTC): research method vs. standard method. The standard method is what is usually performed as standard of care where the radiologist evaluates the ultrasound images of the lymph nodes overall and decides whether each node seen should or should not be biopsied. In the research method, a radiologist evaluates the ultrasound images of the lymph nodes and uses a small, specific checklist of ultrasound appearance to determine whether each node should or should not be biopsied. Information from both of these evaluation methods is recorded to determine which method more accurately identifies the cancer in the lymph node.
For more information about this trial, please visit http://www.mdlinx.com/oncology/clinical-trials/clinical-trial-detail.cfm?nct_id=NCT02442661 or www.clinicaltrials.gov NCT number: NCT02442661
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10-1335: ACRIN 6690: A Prospective, Multicenter Comparison of Multiphase Contrast-Enhanced CT and Multiphase Contrast- Enhanced MRI for Diagnosis of Hepatocellular Carcinoma and Liver Transplant Allocation
The purpose of this study is to determine and compare the accuracy of computed tomography (CT) scans and magnetic resonance imaging (MRI) in diagnosing liver cancer. The most effective way to treat patients with liver cancer and other liver disease may be liver transplantation. With improved imaging methods, the study doctors believe they can improve current methods of listing patients with advanced liver disease on the waitlist for liver transplant. To discover which imaging method gives a clearer picture of liver disease, the images from both the CT and MRI scans will be compared to the actual liver after it is removed during transplant surgery and examined.
For more information about this trial, please visit www.clinicaltrials.gov NCT number: NCT01082224
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15-1608: Registry of Angiovac Procedures In Detail Outcomes Database
PI: Paul Rochon, MD 
15-0537: Predicting the Safety and Effectiveness of Inferior Vena Cava Filters
The purpose of the RAPID registry is to collect information on the Angiovac procedure and Angiovac device. The Angiovac device is used to remove blood clots that form within the vascular system. All patients enrolled in this study will have the Angiovac device placed as part of their standard of care. The data generated by the registry database, used in conjunction with other prospective studies, will evaluate the use, safety, and efficacy of Angiovac for DVT (deep vein thrombosis), PE (pulmonary embolism) and right heart pathology, and will assess the potential advantages and disadvantages of the procedure.
For more information about this trial, please visit http://investors.angiodynamics.com/releasedetail.cfm?releaseid=926187
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15-0537: Predicting the Safety and Effectiveness of Inferior Vena Cava FiltersPI: Paul Rochon, MD
PRESERVE is a large, multi-center clinical trial that aims to prospectively evaluate the safety and efficacy of inferior vena cava (IVC) filters. IVC filters are small metal devices that are placed in the IVC to stop large blood clots from traveling to the lungs. The purpose of this study is to get information about why these filters are used, when they are removed, and to collect health information about patients who have these filters placed. Patients who are enrolled in this study will have an IVC filter placed and will be followed for up to 2 years or 1 month following IVC filter removal, whichever comes first.
For more information about this trial, please visit www.preservetrial.com or www.clinicaltrials.gov NCT number: NCT02381509