Serial MRI Scans During Radiation Therapy (RELAY)

• ClinicalTrials.gov Identifier: NCT04188535
• Recruitment Status: Recruiting
• First Posted: December 6, 2019
• Last Update Posted: April 27, 2020
• Sponsor: Dana-Farber Cancer Institute
• Information provided by (Responsible Party): Lisa Singer, MD PhD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: December 4, 2019
• First Posted Date: December 6, 2019
• Last Update Posted Date: April 27, 2020
• Actual Study Start Date: January 15, 2020
• Estimated Primary Completion Date: July 31, 2025 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 23, 2020)

• 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
• 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

Original Primary Outcome Measures (submitted: December 4, 2019)

• Feasibility-Enrollment [ Time Frame: 1 year ]
  90% lower confidence limit (LCL) on the true feasibility rate feasibility is defined as successfully enrolling patients
• Feasibility -MR Data [ Time Frame: 1 year ]
  90% lower confidence limit (LCL) on the true feasibility rate successfully acquiring MR data at the specified timepoint in a patient's care plan
• Feasibility-Radiation [ Time Frame: 1 year ]
  90% lower confidence limit (LCL) on the true feasibility rate identify the radiation target on the MR data

Current Secondary Outcome Measures (submitted: April 23, 2020)

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

Original Secondary Outcome Measures (submitted: December 4, 2019)

Time to Event [ Time Frame: 1 year ]

evaluated using Kaplan Meier curve estimates

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 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

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 Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Sequential Assignment; Masking: None (Open Label); Primary Purpose: Other

Condition

• Glioblastoma
• Esophageal Cancer
• Radiotherapy
• Magnetic Resonance Imaging
• MRI

Intervention

Diagnostic Test: MRI IMAGING

Imaging with MRI will be performed as per disease site standards.

Study Arms

• 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.
  Intervention: Diagnostic Test: MRI IMAGING
• 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.
  Intervention: Diagnostic Test: MRI IMAGING
• 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.
  Intervention: Diagnostic Test: MRI IMAGING

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: December 4, 2019): 86
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 31, 2025
• Estimated Primary Completion Date: July 31, 2025 (Final data collection date for primary outcome measure)

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Lisa Singer, MD,PhD; 617-732-5734; lsinger1@bwh.harvard.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04188535
• Other Study ID Numbers: 19-573
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• 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

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
• Supporting Materials: Statistical Analysis Plan (SAP)
• Supporting Materials: 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

• Responsible Party: Lisa Singer, MD PhD, Dana-Farber Cancer Institute
• Study Sponsor: Dana-Farber Cancer Institute
• Collaborators: Not Provided

Investigators

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

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: April 2020