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.
15-1296: A Phase III Clinical Trial Evaluating TheraSphere® in Patient with Metastatic Colorectal Carcinoma of the Liver who have Failed First Line Chemotherapy
PI: Thor Johnson, MD PhD
The purpose of the EPOCH study is to see if adding TheraSphere early in second-line chemotherapy is a better treatment than second-line chemotherapy alone for patients who have colorectal cancer that has spread to the liver. TheraSphere is a medical device containing yttrium-90 (Y-90), a radioactive material that has been used to shrink liver tumors. It is delivered into the tumor through a catheter placed into the hepatic artery, which is the main blood supply to the tumor in the liver. The goal with TheraSphere is to provide a large dose of radiation directly to the tumor while preventing toxicity to other parts of the body or to healthy liver tissue. Patients in this study will be randomized to receive either standard-of-care chemotherapy or TheraSphere plus standard-of-care chemotherapy. Patients will return to clinic every 8 weeks for follow-up evaluations.
PI: 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.
15-0438: Accelerated Thrombolysis for Post-Thrombotic Sydrome Using the EKOS System
PI: Thor Johnson, MD PhD
The ACCESS PTS study aims to treat patients who have had a DVT (Deep Vein Thrombosis - a blood clot in the leg) for at least 6 months who are experiencing painful post-thrombotic syndrome (PTS) symptoms due to the lack of blood flow in the leg. Some of these symptoms include swelling, itching, numbness, heaviness, pain, ulcers and redness.
This study uses a commercially-available device called the EkoSonic Endovascular system in combination with thrombolytic drugs to break up the clot and restore blood flow. After the procedure, patients will return to the clinic at 1 month, 3 months, 6 months and 12 months to evaluate the effectiveness of the treatment. During these appointments, ultrasound images will be taken of the legs and questionnaires will be given to assess PTS symptoms and quality of life.
12-0300: Evaluation of Thyroid Stunning from a Diagnostic Dose of I-123
This study uses a test-retest model to evaluate if I-123 causes stunning of thyroid tissue in patients with differentiated thyroid cancer. Thyroid stunning is a temporary decrease in the function of thyroid cells after small doses of radioiodine, a radioactive drug that is commonly used to treat thyroid cancer. There are two important types of radioiodine: I-123 which is a form of radioiodine that is used to image the thyroid gland, and I-131 which is a form of radioiodine that is used to treat thyroid cancer.
In patients who have thyroid cancer that has metastasized (spread to other sites in the body), some researchers believe it is best to give the maximum safe dose of radioiodine in order to have the best chance of treating the cancer. The maximum safe dose is determined by doing a dosimetry study. Currently, it is not known whether the small amount of radioiodine used in the dosimetry study stuns the cancer cells, making the thyroid cancer treatment less effective.
Patients enrolled in this study will not have metastatic thyroid cancer; therefore, thyroid stunning will not be a medical problem for these patients. However, it is hoped that this study will produce important information by proving that I-123 does not cause thyroid stunning and does not make thyroid cancer treatment less effective.
For more information about this trial, please visit www.clinicaltrials.gov NCT number: NCT02278198
16-1313: SPEED 1 Trial: Bridge to Orthotopic Liver Transplantation (OLT) - (Surefire Precision vs Endhole Embolization with DEBTACE)
PI: Thor Johnson, MD, PhD
The purpose of this study is to evaluate the outcomes of patients with hepatocellular carcinoma (HCC) who undergo transarterial chemoembolization with doxorubicin-eluting beads (DEB-TACE) with the Surefire Precision Infusion System. DEB-TACE is a procedure that uses microscopic beads containing anticancer drugs that are administered directly into the tumor and the blood supply to the tumor. When patients have too much cancer in their liver, they are unable to receive a liver transplant. One way patients can become more likely to receive a transplant is if some of their cancer is treated with DEB-TACE. The goal of this study is to increase the patient’s chances to be selected for a liver transplant. Also, this study aims to learn more about how cancer in the liver responds in patients who receive DEB-TACE with the Surefire Precision Infusion System.
16-1074: Early feeding following percutaneous gastrostomy tube placement
PI: Thor Johnson, MD PhD
This study plans to learn more about the safety of early feeding following placement of a feeding tube. Doctors in other specialties feed patients 4 hours after patients receive a feeding tube. However, Interventional Radiologists typically wait to feed patients for 24 hours following feeding tube placement. Patients in this study will have a feeding tube placed as a part of the standard treatment and randomly selected to be fed 4 hours (early) or 24 hours (standard) after the feeding tube is placed. The goal is to demonstrate that feeding after 4 hours does not increase complications and can actually reduce the burden to patients who receive a feeding tube.
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.
If you are a patient interested in finding out more about any of these studies, please contact our Radiology Clinical Research Coordinator.
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
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
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