Serial MRI Scans During Radiation Therapy

Prostate Cancer Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04188535
• Other study ID #: 19-573
• Status: Recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: July 31, 2025

Study information

• Verified date: August 2023
• Source: Dana-Farber Cancer Institute
• Contact: Jonathan Leeman, MD
• Phone: (617) 732-6452
• Email: JONATHANE_LEEMAN[@]DFCI.HARVARD.EDU
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 139
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Esophageal Cancer
• Esophageal Neoplasms
• Glioblastoma
• Magnetic Resonance Imaging
• MRI
• Pediatric Glioblastoma Multiforme
• Prostate Cancer
• Prostatic Neoplasms
• Radiotherapy
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

Diagnostic Test:
• MRI IMAGING
Imaging with MRI will be performed as per disease site standards.

Locations

Country	Name	City	State
United States	Brigham and Women Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 year
Primary	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.	2 years
Secondary	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.	1 year