Serial MRI Scans During Radiation Therapy

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Brief Title

Serial MRI Scans During Radiation Therapy

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

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 or

      The research study procedures include three MRI scans (one pre treatment, during and post
      standard care cancer radiation therapy) for participants with advanced esophageal cancer or

      The research study procedures include:

        -  Screening for eligibility

        -  Three MRI scans

Detailed Description

      This 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

      This research study is a feasibility study, which means it is the first-time investigators at
      this institution are examining the process of getting multiple MRIs during radiation

      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

        -  Three MRI scans (Imaging with MRI will be performed as per disease site standards.)

        -  A total of 86 participants will be enrolled in this trial

        -  Phase 1

             -  20 participants in Esophageal Cohort

             -  20 Participants in Glioblastoma Cohort

        -  Expansion Cohort --- 46 Participants in the Glioblastoma Expansion Cohort

Study Type


Primary Outcome

Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy

Secondary Outcome

 Dosimetric Change





Study Arms / Comparison Groups

 Esophageal Cohort
Description:  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.


* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Diagnostic Test

Estimated Enrollment


Start Date

January 15, 2020

Completion Date

July 31, 2025

Primary Completion Date

July 31, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must have a confirmed malignancy requiring radiation therapy.

          -  Age: 18 years or older

          -  ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)

          -  Ability to understand and the willingness to sign a written informed consent document.

          -  Any further criteria listed in the specific disease site sub protocol

               -  Patients must be considered appropriate candidates for neoadjuvant chemoradiation
                  therapy followed by esophagectomy

               -  Patients with a histologically confirmed newly diagnosed intracranial
                  glioblastoma or gliosarcoma who will be undergoing radiation therapy as part of
                  clinical care.

        Exclusion Criteria

          -  Disease-specific exclusion criteria will be specified in a sub protocol.

          -  For MRI involving contrast, history of allergic reactions attributed to gadolinium
             based IV contrast.

             -- Note: If patient will not receive contrast, this is not applicable and kidney
             function will not affect eligibility

          -  Unable to undergo magnetic resonance imaging (MRI)




18 Years - N/A

Accepts Healthy Volunteers



Lisa Singer, MD, PhD, 617-732-5734, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations



Organization ID


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute

Study Sponsor

Lisa Singer, MD, PhD, Principal Investigator, Dana-Farber Cancer Institute

Verification Date

March 2021