Ignite Creation Date:
2025-12-24 @ 10:21 PM
Ignite Modification Date:
2025-12-24 @ 10:21 PM
Study NCT ID:
NCT04188535
Status:
RECRUITING
Last Update Posted:
2025-08-26
First Post:
2019-12-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Serial MRI Scans During Radiation Therapy
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
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
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RELAY
Brief 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
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
Detailed 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 149 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
* 10 participants in the sarcoma cohort
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 149 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
* 10 participants in the sarcoma cohort
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: