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

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

Study Overview

• Status: Recruiting
• Conditions: MRI; Glioblastoma; Esophageal Cancer; Prostate Cancer; Vulvar Cancer; Magnetic Resonance Imaging; Radiotherapy; Pediatric Glioblastoma Multiforme
• Intervention / Treatment: Diagnostic test: MRI IMAGING

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 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

• Study Type: Interventional
• Enrollment (Estimated): 139
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jonathan Leeman, MD; Phone Number: (617) 732-6452; Email: JONATHANE_LEEMAN@DFCI.HARVARD.EDU

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana Farber Cancer Institute
      • Principal Investigator: Jonathan Leeman, MD
      • Contact: Jonathan Leeman, MD; Phone Number: 617-732-6452; Email: JONATHANE_LEEMAN@DFCI.HARVARD.EDU
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Brigham and Women Hospital
      • Contact: Jonathan Leeman, MD; Email: JONATHANE_LEEMAN@DFCI.HARVARD.EDU
      • Principal Investigator: Jonathan Leeman, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Disease-specific exclusion criteria will be specified in a subprotocol.
• 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

7

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Esophageal Cohort; 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.	Diagnostic test: MRI IMAGING; Imaging with MRI will be performed as per disease site standards.
Experimental: Glioblastoma Cohort; 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.	Diagnostic test: MRI IMAGING; Imaging with MRI will be performed as per disease site standards.
Experimental: Glioblastoma Expansion Cohort Serial MR Imaging Registry; 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.	Diagnostic test: MRI IMAGING; Imaging with MRI will be performed as per disease site standards.
Experimental: Prostate Cancer Cohort; 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	Diagnostic test: MRI IMAGING; Imaging with MRI will be performed as per disease site standards.
Experimental: Prostate Cancer Expansion Cohort Serial MR Imaging Registry; 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	Diagnostic test: MRI IMAGING; Imaging with MRI will be performed as per disease site standards.
Experimental: Vulvar Cancer Cohort; 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.	Diagnostic test: MRI IMAGING; Imaging with MRI will be performed as per disease site standards.
Experimental: Pediatric Glioma Cohort; 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.	Diagnostic test: MRI IMAGING; Imaging with MRI will be performed as per disease site standards.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dosimetric change	For subprotocols studying the adaptive treatment, the secondary objective is dosimetric change in the in silico adaptive radiation therapy plans, without delivering adaptive plans in Phase I.	1 year

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Jonathan Leeman, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2020
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): July 31, 2025

Study Registration Dates

• First Submitted: December 4, 2019
• First Submitted That Met QC Criteria: December 4, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): August 21, 2023
• Last Update Submitted That Met QC Criteria: August 17, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: MRI; Prostate Cancer; Magnetic Resonance Imaging; Radiotherapy; Glioblastoma; Esophageal Cancer; Vulvar Cancer; Pediatric Glioblastoma Multiforme
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Genital Neoplasms, Female; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Genital Neoplasms, Male; Prostatic Diseases; Head and Neck Neoplasms; Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Esophageal Diseases; Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Genital Diseases, Female; Prostatic Neoplasms; Glioblastoma; Vulvar Neoplasms; Esophageal Neoplasms
• Other Study ID Numbers: 19-573

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication.
• IPD Sharing Access Criteria: DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes