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MRI Scans During Radiation Therapy for Cancer (RELAY Trial)

N/A
Recruiting
Led By Jonathan Leeman, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
Participants must have a confirmed malignancy requiring radiation therapy.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

RELAY Trial Summary

This trial is to study if using MRIs to track response to radiation therapy is feasible and useful for patients with certain types of cancer.

Who is the study for?
This trial is for adults with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer or pediatric high-grade glioma who need radiation therapy. They must be in a condition to understand and sign consent. Exclusions include allergies to MRI contrast (unless not using contrast) and inability to undergo MRI.Check my eligibility
What is being tested?
The study tests the use of serial MRIs—before, during, and after standard radiation therapy—to monitor treatment response in patients with certain advanced cancers. It's a phase 1 trial focused on feasibility and utility of this imaging technique during treatment.See study design
What are the potential side effects?
There are generally no side effects associated directly with undergoing an MRI scan itself; however, if contrast is used there's a small risk of allergic reaction for those sensitive to gadolinium-based contrasts.

RELAY Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My cancer needs radiation treatment.
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I have localized prostate cancer and will get hormone therapy and radiation.
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I have a new diagnosis of glioblastoma or gliosarcoma and will be receiving radiation therapy.
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I have advanced vulvar cancer and will undergo definitive radiotherapy.
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I am 18 years old or older.
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I am a suitable candidate for chemotherapy and radiation before esophagus surgery.

RELAY Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Ability to measure disease control (for imaging registry expansion cohort)
Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy
Secondary outcome measures
Dosimetric change

RELAY Trial Design

7Treatment groups
Experimental Treatment
Group I: Vulvar Cancer CohortExperimental Treatment1 Intervention
The research study procedures include: Screening for eligibility Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.
Group II: Prostate Cancer Expansion Cohort Serial MR Imaging RegistryExperimental Treatment1 Intervention
The research study procedures include: Screening for eligibility Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards. Genomic testing of biopsy sample
Group III: Prostate Cancer CohortExperimental Treatment1 Intervention
The research study procedures include: Screening for eligibility Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards. Genomic testing of biopsy sample
Group IV: Pediatric Glioma CohortExperimental Treatment1 Intervention
The research study procedures include: Screening for eligibility Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.
Group V: Glioblastoma Expansion Cohort Serial MR Imaging RegistryExperimental Treatment1 Intervention
The research study procedures include: Screening for eligibility Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.
Group VI: Glioblastoma CohortExperimental Treatment1 Intervention
The research study procedures include: Screening for eligibility Three MRI scans prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.
Group VII: Esophageal CohortExperimental Treatment1 Intervention
The research study procedures include: Screening for eligibility Three MRI scans (prior to start of standard cancer treatment, in the middle, and at the end of radiation treatment). Imaging with MRI will be performed as per disease site standards.

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,809 Total Patients Enrolled
Jonathan Leeman, MDPrincipal Investigator - Dana-Farber Cancer Institute
Dana-Farber Cancer Institute
3 Previous Clinical Trials
629 Total Patients Enrolled

Media Library

MRI IMAGING Clinical Trial Eligibility Overview. Trial Name: NCT04188535 — N/A
Radiotherapy Research Study Groups: Esophageal Cohort, Glioblastoma Expansion Cohort Serial MR Imaging Registry, Vulvar Cancer Cohort, Glioblastoma Cohort, Pediatric Glioma Cohort, Prostate Cancer Cohort, Prostate Cancer Expansion Cohort Serial MR Imaging Registry
Radiotherapy Clinical Trial 2023: MRI IMAGING Highlights & Side Effects. Trial Name: NCT04188535 — N/A
MRI IMAGING 2023 Treatment Timeline for Medical Study. Trial Name: NCT04188535 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants have been accepted for inclusion in this trial?

"Affirmative. The information on clinicaltrials.gov verifies that this scientific investigation is actively seeking patients. This study was initiated on January 15th, 2020 and its parameters were last updated August 8th 2022. In total, 166 participants need to be enrolled at 2 distinct sites of research."

Answered by AI

Is the enrollment process for this clinical experiment still open?

"Affirmative. Clinicaltrials.gov verifies that this medical study, which was originally posted on January 15th 2020, is actively recruiting participants. 166 patients are needed to be recruited from two distinct healthcare facilities."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Serial MRI Scans During Radiation Therapy
Jonathan Leeman, MD 2020. "Serial MRI Scans During Radiation Therapy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04188535.
All > Esophagus Cancer > Glioblastoma Multiforme
~32 spots leftby Jul 2025
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