Serial MRI Scans During Radiation Therapy
RELAY
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
1 other identifier
interventional
149
1 country
2
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2020
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 4, 2019
CompletedFirst Posted
Study publicly available on registry
December 6, 2019
CompletedStudy Start
First participant enrolled
January 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2030
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 31, 2030
August 26, 2025
August 1, 2025
10.5 years
December 4, 2019
August 20, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy
90% lower confidence limit (LCL) on the true feasibility rate. Feasibility is defined as successfully enrolling patients, acquiring MRI data at all timepoints, identifying the target on MRI data obtained at all timepoints, and processing MRI data at all timepoints to yield pre-specified MRI-derived measurements.
1 year
Ability to measure disease control (for imaging registry expansion cohort)
Validating a previously developed predictive model to identify the most likely area of recurrence using MRI-based features.
2 years
Secondary Outcomes (1)
Dosimetric change
1 year
Study Arms (8)
Esophageal Cohort
EXPERIMENTALThe 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.
Glioblastoma Cohort
EXPERIMENTALThe 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.
Glioblastoma Expansion Cohort Serial MR Imaging Registry
EXPERIMENTALThe 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.
Prostate Cancer Cohort
EXPERIMENTALThe 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
Prostate Cancer Expansion Cohort Serial MR Imaging Registry
EXPERIMENTALThe 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
Vulvar Cancer Cohort
EXPERIMENTALThe 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.
Pediatric Glioma Cohort
EXPERIMENTALThe 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.
Sarcoma Cohort
EXPERIMENTALThe 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.
Interventions
Imaging with MRI will be performed as per disease site standards.
Eligibility Criteria
You may qualify if:
- Participants must have a confirmed malignancy requiring radiation therapy.
- Age: 18 years or older except where otherwise specified in subprotocol.
- ECOG performance status ≤2 (Karnofsky ≥60%)
- Ability to understand and the willingness to sign a written informed consent document.
- Any further criteria listed in the specific disease site subprotocol.
- (Esophageal cohort) Patients must be considered appropriate candidates for neoadjuvant chemoradiation therapy followed by esophagectomy. Patients must have an endoscopic ultrasound done or scheduled to be done at the baseline visit.
- (Glioblastoma cohort) Patients with a histologically confirmed newly diagnosed intracranial glioblastoma or gliosarcoma who will be undergoing radiation therapy as part of clinical care.
- (Prostate cohort) Patients with localized prostate cancer who are planning to receive androgen deprivation therapy and definitive radiation therapy.
- (Vulvar cohort) Patients with biopsy-proven locally advanced vulvar cancer for which definitive radiotherapy is planned.
- (Pediatric glioma cohort) Patients age 18 or under (patients 18-30 years old are also eligible if the physician determines that based on genetics, the tumor biology is consistent with pediatric high grade glioma). Patients with a histologically confirmed newly diagnosed high-grade glioma (WHO grade III or IV) who will be undergoing radiation therapy as part of clinical care. Patients with DIPG are only eligible if biopsy-confirmed high grade DIPG is present. Ability to understand and/or willingness of their parent or legally authorized representative to sign a written informed consent document.
You may not qualify if:
- For MRI involving contrast, history of allergic reactions attributed to gadolinium-based IV contrast. If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility.
- Inability to undergo magnetic resonance imaging (MRI).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Brigham and Women Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jonathan Leeman, MD
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
December 4, 2019
First Posted
December 6, 2019
Study Start
January 15, 2020
Primary Completion (Estimated)
July 31, 2030
Study Completion (Estimated)
July 31, 2030
Last Updated
August 26, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication.
- Access Criteria
- DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.