Serial MRI Scans During Radiation Therapy — RELAY  

Prostate Cancer Clinical Trial

Official title: RELAY: Repeated Magnetic Resonance Imaging Examinations to Analyze and Assess Your Cancer: A Prospective Study on the Use of Serial Magnetic Resonance Imaging in the Assessment of Changes During Treatment With Radiation Therapy

Status Recruiting

Clinical Trial Summary

This is a phase 1 study to determine the feasibility and utility of using serial magnetic resonance imaging (MRI) to assess treatment response during and after radiation therapy (standard of care cancer treatment) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma.

The research study procedures include three MRI scans (one before, one during, and one after standard of care cancer radiation therapy) for participants with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric glioma.

The research study procedures include:

• Screening for eligibility

• Three MRI scans

Clinical Trial Description

This is a phase 1, non-randomized, open-label study evaluating feasibility of serial MRI, with an option for an expansion cohort. The optional expansion cohort is a prospective imaging registry evaluating imaging biomarkers as predictors of disease control with standard of care treatment.

This research study is a feasibility study, meaning that it is the first time that investigators at this institution are examining the process of getting multiple MRIs during radiation treatment.

The U.S. Food and Drug Administration (FDA) has cleared this MRI scanner for use.

Participants who fulfill eligibility criteria will be entered into the trial.

The research study procedures include screening for eligibility, and three MRI scans. MRI imaging will be performed as per disease site standards.

A total of 139 participants will be enrolled in this trial:

• 13 participants in the esophageal cancer cohort

• 10 participants in the initial glioblastoma cohort and 36 participants in the image registry expansion cohort

• 10 participants in the prostate cancer cohort and 50 participants in the image registry expansion cohort

• 10 participants in the vulvar cancer cohort

• 10 participants in the pediatric glioma cohort ;

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Glioblastoma
• Magnetic Resonance Imaging
• MRI
• Pediatric Glioblastoma Multiforme
• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy
• Vulvar Cancer
• Vulvar Neoplasms

• NCT number: NCT04188535
• Study type: Interventional
• Source: Dana-Farber Cancer Institute
• Contact: Jonathan Leeman, MD
• Phone: (617) 732-6452
• Email: JONATHANE_LEEMAN@DFCI.HARVARD.EDU
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2020
• Completion date: July 31, 2025