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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 : April 27, 2020
Sponsor:
Information provided by (Responsible Party):
Lisa Singer, MD PhD, Dana-Farber Cancer Institute

Study Description
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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 glioblastoma.

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 glioblastoma

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 Diagnostic Test: MRI IMAGING Not Applicable

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 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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 86 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


Arms and Interventions
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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.


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. Ability to measure disease control (for imaging expansion cohort) [ Time Frame: 2 years ]
    Validating a previously developed predictive model to identify most likely area of recurrence using MRI-based features


Secondary Outcome Measures :
  1. 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
  • 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)
Contacts and Locations
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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: Lisa Singer, MD,PhD 617-732-5734 lsinger1@bwh.harvard.edu

Locations
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United States, Massachusetts
Brigham and Women Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lisa Singer, MD, PhD    617-732-5734      
Principal Investigator: Lisa Singer, MD, PhD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02215
Contact: Lisa Singer, MD, PHD    617-732-5734      
Principal Investigator: Lisa Singer, MD, PhD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Lisa Singer, MD, PhD Dana-Farber Cancer Institute
More Information
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Responsible Party: Lisa Singer, MD PhD, 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: April 27, 2020
Last Verified: April 2020
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 Lisa Singer, MD PhD, Dana-Farber Cancer Institute:
Glioblastoma
Esophageal Cancer
Radiotherapy
Magnetic Resonance Imaging
MRI
Additional relevant MeSH terms:
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Glioblastoma
Esophageal Neoplasms
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
 Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases