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

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Brigham and Women Hospital
RECRUITING
Boston
Dana Farber Cancer Institute
RECRUITING
Boston
Contact Information
Primary
Jonathan Leeman, MD
JONATHANE_LEEMAN@DFCI.HARVARD.EDU
(617) 732-6452
Time Frame
Start Date: 2020-01-15
Estimated Completion Date: 2030-07-31
Participants
Target number of participants: 149
Treatments
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.
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.
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.
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
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
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.
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.
Experimental: Sarcoma 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.
Authors
Lisa Singer
Sponsors
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov