Sponsored Clinical Research Program
The UMass Chan Medical School’s Department of Radiology includes a successful and growing Sponsored Clinical Research Program. With support from a number of international industry sponsors, the Department maintains a diverse portfolio of clinical trials on research areas that are specific to the interests of participating UMass investigators. These trials are applicable to the UMass area’s patient population as well as generalizable to a wider population, with many promising improved standards of care in radiology, development of novel diagnostic tests, or expanding our knowledge of disease etiology and progression as well as imaging modalities. If you are interested in learning more about any of the below studies, please contact Sara Schiller, Research Program Manager, at sara.schiller1@umassmed.edu.
DEEP-Lung-IV: Deep Learning Enabled Exploration of Predictive Signatures in Patients with Stage IV Non-Small Cell Lung Cancer
Sponsor: SOPHiA Genetics, France
Principal Investigator: Alexander Bankier, MD, PhD
The DEEP-Lung-IV is a multicenter retrospective and prospective observational study of patients with stage IV (late stage) non-small cell lung cancer. In this study, multiple sources of data, including patient medical history, biological information, genomics, and radiomics, are aggregated to allow for analysis of how patients respond to lung cancer treatment and their ultimate prognosis. In tandem with this research, SOPHiA Genetics is developing a multimodal research application where investigators may utilize de-identified data gathered in the DEEP-Lung-IV study for their own hypothesis generation and exploratory research proposals.
NOBLE: Nose Brushings for Lung Cancer Assessment in Epithelium
Sponsor: Veracyte, California
Principal Investigator: Alexander Bankier, MD, PhD
NOBLE is a prospective study focused on the development and evaluation of a novel biomarker test to aid in the risk assessment of lung nodules detected during lung cancer screening scans. The genomic test utilizes a blood sample and brushings from the nasal linings (like a COVID test), which are then compared to the final diagnosis of nodules found during routine imaging. In the future, this test may help to diagnose lung cancer earlier and provide improved information on a patient’s level of risk for developing lung cancer.
BOSTON II: Diagnostic Performance of Small RNA Blood Test in Patients Undergoing Follow-Up Imaging After Positive CT Screening of the Lung
Sponsor: Hummingbird, Germany
Principal Investigator: Alexander Bankier, MD, PhD
BOSTON-II is a prospective observational study of a non-invasive blood test that relies on RNA signatures to aid in the diagnosis of lung cancer. This study includes patients who have had a positive lung cancer screening scan as part of their routine care.
AC1804: Collection of Malignant Pleural Effusion and Ascites Fluids from Cancer Patients for Ex Vivo Drug Response Profiling
Sponsor: Exscientia, Austria/UK
Principal Investigator: Alexander Bankier, MD, PhD
AC1804 is a pilot study where leftover pleural effusion or ascites samples will be collected from patients diagnosed with various types of cancer. These samples will then be used to measure how both healthy and cancerous cells within the sample respond to multiple drugs that are either in clinical use or under development. Samples will also undergo genomic analysis to aid in the development of future targeted treatments for cancer.
ODYSSEY: Long-term Impact of GBCAs on Motor and Cognitive Function Following Repeated Contrast-Enhanced MRI
Sponsor: Bayer, Bracco, Guerbet
Principal Investigator: B. Nicolas Bloch, MD
In this post-marketing clinical study, patients who receive annual contrast-enhanced MRI for their standard clinical care (i.e., breast cancer screening MRIs) undergo motor and cognitive testing each year for five years to assess long-term health impacts of repeat contrast agent administration.
Contrast Enhanced Breast MRI: Comparison of Two Macrocyclic Gadolinium-Based Contrast Agents: Dotarem and Gadavist. A Prospective Study
Sponsor: Guerbet
Principal Investigator: B. Nicolas Bloch, MD
This study compares two FDA-approved, commonly used contrast agents utilized in MR imaging, Dotarem and Gadavist, to assess the quality of images produced. Women for whom a standard of care breast MRI is ordered are randomized to receive one of the two contrast agents. Study doctors who are blinded to the type of contrast agent received review their MR images to determine if one agent produces better quality images than the other.
MIRAI-MRI: Comparing Screening MRI for Patients at High Risk of Breast Cancer Identified by Mirai and Tyrer-Cuzick
Sponsor: Breast Cancer Research Foundation
Principal Investigator: Mohammed Salman Shazeeb, PhD
In this study, we are utilizing a newly developed artificial intelligence software tool, called Mirai, to help determine if some women at high risk of breast cancer require additional imaging to detect breast cancer earlier, and to learn what percentage of these women go on to develop a breast cancer in the future. This will help to determine if Mirai is better than the currently used tools for predicting risk of cancer.