RELAY: Serial MRI Scans During Radiation Therapy

Sponsor

Dana-Farber Cancer Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT04188535

Collaborator

(none)

166

Enrollment

Locations

Arms

66.5

Anticipated Duration (Months)

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

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 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

Condition or Disease	Intervention/Treatment	Phase
Glioblastoma Esophageal Cancer Radiotherapy Magnetic Resonance Imaging MRI Prostate Cancer Vulvar Cancer Pediatric Glioblastoma Multiforme	Diagnostic Test: MRI IMAGING	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

166 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 :

Jan 15, 2020

Anticipated Primary Completion Date :

Jul 31, 2025

Anticipated Study Completion Date :

Jul 31, 2025

Arms and Interventions

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.
Experimental: Prostate Cancer Cohort 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	Diagnostic Test: MRI IMAGING Imaging with MRI will be performed as per disease site standards.
Experimental: Prostate Cancer Expansion Cohort Serial MR Imaging Registry 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	Diagnostic Test: MRI IMAGING Imaging with MRI will be performed as per disease site standards.
Experimental: Vulvar Cancer 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: Pediatric Glioma 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.

Outcome Measures

Primary Outcome Measures

Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy [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) [2 years]
Validating a previously developed predictive model to identify most likely area of recurrence using MRI-based features

Secondary Outcome Measures

Dosimetric Change [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

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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