Serial MRI Scans During Radiation Therapy (RELAY)

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ClinicalTrials.gov Identifier: NCT04188535

Recruitment Status : Recruiting

First Posted : December 6, 2019

Last Update Posted : August 21, 2023

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View this study on the modernized ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Jonathan Leeman, MD, Dana-Farber Cancer Institute

Study Description

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

Condition or disease	Intervention/treatment	Phase
Glioblastoma Esophageal Cancer Radiotherapy Magnetic Resonance Imaging MRI Prostate Cancer Vulvar Cancer Pediatric Glioblastoma Multiforme	Diagnostic Test: MRI IMAGING	Not Applicable

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 Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	139 participants
Allocation:	Non-Randomized
Intervention Model:	Sequential Assignment
Masking:	None (Open Label)
Primary Purpose:	Other
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
Actual Study Start Date :	January 15, 2020
Estimated Primary Completion Date :	July 31, 2025
Estimated Study Completion Date :	July 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Prostate cancer

MedlinePlus related topics: Diagnostic Imaging MRI Scans

Genetic and Rare Diseases Information Center resources: Glioblastoma Esophageal Cancer Vulvar Cancer Glioma Neuroepithelioma

U.S. FDA Resources

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy [ Time Frame: 1 year ]
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.
Ability to measure disease control (for imaging registry expansion cohort) [ Time Frame: 2 years ]
Validating a previously developed predictive model to identify the most likely area of recurrence using MRI-based features.

Secondary Outcome Measures :

Dosimetric change [ Time Frame: 1 year ]
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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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).

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04188535

Contacts

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Contact: Jonathan Leeman, MD	(617) 732-6452	JONATHANE_LEEMAN@DFCI.HARVARD.EDU

Locations

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

Sponsors and Collaborators

Dana-Farber Cancer Institute

Investigators

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

More Information

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Responsible Party:	Jonathan Leeman, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT04188535
Other Study ID Numbers:	19-573
First Posted:	December 6, 2019 Key Record Dates
Last Update Posted:	August 21, 2023
Last Verified:	August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	Yes
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.
Supporting Materials:	Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (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

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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

Keywords provided by Jonathan Leeman, MD, Dana-Farber Cancer Institute:


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

Additional relevant MeSH terms:

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Prostatic Neoplasms Glioblastoma Esophageal Neoplasms Vulvar Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Genital Diseases Urogenital Diseases Prostatic Diseases Male Urogenital Diseases Astrocytoma Glioma	Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Gastrointestinal Neoplasms Digestive System Neoplasms Head and Neck Neoplasms Digestive System Diseases Esophageal Diseases Gastrointestinal Diseases Genital Neoplasms, Female Vulvar Diseases Genital Diseases, Female

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