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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

Tracking Information
First Submitted Date  ICMJE December 4, 2019
First Posted Date  ICMJE December 6, 2019
Last Update Posted Date April 27, 2020
Actual Study Start Date  ICMJE January 15, 2020
Estimated Primary Completion Date July 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (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
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Serial MRI Scans During Radiation Therapy
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE
  • Glioblastoma
  • Esophageal Cancer
  • Radiotherapy
  • Magnetic Resonance Imaging
  • MRI
Intervention  ICMJE Diagnostic Test: MRI IMAGING
Imaging with MRI will be performed as per disease site standards.
Study Arms  ICMJE
  • 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

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 4, 2019)
86
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 31, 2025
Estimated Primary Completion Date July 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Lisa Singer, MD,PhD 617-732-5734 lsinger1@bwh.harvard.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04188535
Other Study ID Numbers  ICMJE 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  ICMJE
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  ICMJE Dana-Farber Cancer Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Lisa Singer, MD, PhD Dana-Farber Cancer Institute
PRS Account Dana-Farber Cancer Institute
Verification Date April 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP