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Serial MRI Scans During Radiation Therapy (RELAY)

Primary Purpose

Glioblastoma, Esophageal Cancer, Radiotherapy

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MRI IMAGING
Sponsored by
Dana-Farber Cancer Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Glioblastoma focused on measuring Glioblastoma, Esophageal Cancer, Radiotherapy, Magnetic Resonance Imaging, MRI, Prostate Cancer, Vulvar Cancer, Pediatric Glioblastoma Multiforme

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Brigham and Women HospitalRecruiting
  • Dana Farber Cancer InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Esophageal Cohort

Glioblastoma Cohort

Glioblastoma Expansion Cohort Serial MR Imaging Registry

Prostate Cancer Cohort

Prostate Cancer Expansion Cohort Serial MR Imaging Registry

Vulvar Cancer Cohort

Pediatric Glioma Cohort

Arm 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.

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.

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.

The research study procedures include: Screening for eligibility Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards. Genomic testing of biopsy sample

The research study procedures include: Screening for eligibility Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards. Genomic testing of biopsy sample

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.

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.

Outcomes

Primary Outcome Measures

Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy
90% lower confidence limit (LCL) on the true feasibility rate. Feasibility is defined as successfully enrolling patients, acquiring MRI data at all timepoints, identifying the target on MRI data obtained at all timepoints, and processing MRI data at all timepoints to yield pre-specified MRI-derived measurements.
Ability to measure disease control (for imaging registry expansion cohort)
Validating a previously developed predictive model to identify the most likely area of recurrence using MRI-based features.

Secondary Outcome Measures

Dosimetric change
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.

Full Information

First Posted
December 4, 2019
Last Updated
August 17, 2023
Sponsor
Dana-Farber Cancer Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04188535
Brief Title
Serial MRI Scans During Radiation Therapy
Acronym
RELAY
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2020 (Actual)
Primary Completion Date
July 31, 2025 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dana-Farber Cancer Institute

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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 before, one during, and one after standard of 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 is a 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, meaning that it is the first time that 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, and three MRI scans. MRI imaging will be performed as per disease site standards. A total of 139 participants will be enrolled in this trial: 13 participants in the esophageal cancer cohort 10 participants in the initial glioblastoma cohort and 36 participants in the image registry expansion cohort 10 participants in the prostate cancer cohort and 50 participants in the image registry expansion cohort 10 participants in the vulvar cancer cohort 10 participants in the pediatric glioma cohort

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glioblastoma, Esophageal Cancer, Radiotherapy, Magnetic Resonance Imaging, MRI, Prostate Cancer, Vulvar Cancer, Pediatric Glioblastoma Multiforme
Keywords
Glioblastoma, Esophageal Cancer, Radiotherapy, Magnetic Resonance Imaging, MRI, Prostate Cancer, Vulvar Cancer, Pediatric Glioblastoma Multiforme

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
139 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Esophageal Cohort
Arm Type
Experimental
Arm 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.
Arm Title
Glioblastoma Cohort
Arm Type
Experimental
Arm 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.
Arm Title
Glioblastoma Expansion Cohort Serial MR Imaging Registry
Arm Type
Experimental
Arm 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.
Arm Title
Prostate Cancer Cohort
Arm Type
Experimental
Arm Description
The research study procedures include: Screening for eligibility Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards. Genomic testing of biopsy sample
Arm Title
Prostate Cancer Expansion Cohort Serial MR Imaging Registry
Arm Type
Experimental
Arm Description
The research study procedures include: Screening for eligibility Three MRI scans prior to start of androgen deprivation therapy, prior to the start of radiation treatment, and after radiation treatment). Imaging with MRI will be performed as per disease site standards. Genomic testing of biopsy sample
Arm Title
Vulvar Cancer Cohort
Arm Type
Experimental
Arm 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.
Arm Title
Pediatric Glioma Cohort
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
MRI IMAGING
Intervention Description
Imaging with MRI will be performed as per disease site standards.
Primary Outcome Measure Information:
Title
Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy
Description
90% lower confidence limit (LCL) on the true feasibility rate. Feasibility is defined as successfully enrolling patients, acquiring MRI data at all timepoints, identifying the target on MRI data obtained at all timepoints, and processing MRI data at all timepoints to yield pre-specified MRI-derived measurements.
Time Frame
1 year
Title
Ability to measure disease control (for imaging registry expansion cohort)
Description
Validating a previously developed predictive model to identify the most likely area of recurrence using MRI-based features.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Dosimetric change
Description
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.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants must have a confirmed malignancy requiring radiation therapy. Age: 18 years or older except where otherwise specified in subprotocol. ECOG performance status ≤2 (Karnofsky ≥60%) Ability to understand and the willingness to sign a written informed consent document. Any further criteria listed in the specific disease site subprotocol. (Esophageal cohort) Patients must be considered appropriate candidates for neoadjuvant chemoradiation therapy followed by esophagectomy. Patients must have an endoscopic ultrasound done or scheduled to be done at the baseline visit. (Glioblastoma cohort) Patients with a histologically confirmed newly diagnosed intracranial glioblastoma or gliosarcoma who will be undergoing radiation therapy as part of clinical care. (Prostate cohort) Patients with localized prostate cancer who are planning to receive androgen deprivation therapy and definitive radiation therapy. (Vulvar cohort) Patients with biopsy-proven locally advanced vulvar cancer for which definitive radiotherapy is planned. (Pediatric glioma cohort) Patients age 18 or under (patients 18-30 years old are also eligible if the physician determines that based on genetics, the tumor biology is consistent with pediatric high grade glioma). Patients 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. Ability to understand and/or willingness of their parent or legally authorized representative to sign a written informed consent document. Exclusion Criteria: Disease-specific exclusion criteria will be specified in a subprotocol. For MRI involving contrast, history of allergic reactions attributed to gadolinium-based IV contrast. If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility. Inability to undergo magnetic resonance imaging (MRI).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jonathan Leeman, MD
Phone
(617) 732-6452
Email
JONATHANE_LEEMAN@DFCI.HARVARD.EDU
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Leeman, MD
Organizational Affiliation
Dana-Farber Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Leeman, MD
Email
JONATHANE_LEEMAN@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Jonathan Leeman, MD
Facility Name
Dana Farber Cancer Institute
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jonathan Leeman, MD
Phone
617-732-6452
Email
JONATHANE_LEEMAN@DFCI.HARVARD.EDU
First Name & Middle Initial & Last Name & Degree
Jonathan Leeman, MD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Data can be shared no earlier than 1 year following the date of publication.
IPD Sharing Access Criteria
DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Learn more about this trial

Serial MRI Scans During Radiation Therapy

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