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,
      glioblastoma, prostate cancer, vulvar cancer or pediatric glioma.

      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,
      glioblastoma, prostate cancer, vulvar cancer or pediatric glioma.

      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
      treatment.

      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
      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

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

        -  A total of 166 participants will be enrolled in this trial

        -  Phase 1

             -  20 participants in Esophageal Cohort

             -  20 Participants in Glioblastoma Cohort

             -  10 Participants in Prostate Cancer Cohort

             -  10 Participants in Vulvar Cancer Cohort

             -  10 Participants in Pediatric Glioma Cohort

        -  Expansion Cohort

             -  46 Participants in the Glioblastoma Expansion Cohort

             -  50 Participants in the Prostate Cancer Expansion Cohort
    


Study Type

Interventional


Primary Outcome

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

Secondary Outcome

 Dosimetric Change

Condition

Glioblastoma

Intervention

MRI IMAGING

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.

Publications

* 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

166

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.

               -  Patients with localized prostate caner who are planned to receive androgen
                  deprivation therapy and definitive radiation therapy.

               -  Patients with Biopsy-proven locally advanced vulvar cancer for which definitive
                  radiotherapy is planned

               -  Patients who are age 18 or under (or 18-30 if physician determines that biology
                  is consistent with pediatric high grade glioma) 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.

        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)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Jonathan Leeman, MD, (617) 732-6452, [email protected]

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT04188535

Organization ID

19-573


Responsible Party

Principal Investigator

Study Sponsor

Dana-Farber Cancer Institute


Study Sponsor

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


Verification Date

August 2021