Serial MRI Scans During Radiation Therapy

Phase

N/A

Condition

Esophageal Cancer

Prostate Cancer

Prostate Cancer, Early, Recurrent

Treatment

MRI IMAGING

Clinical Study ID

NCT04188535

19-573

Ages > 18
All Genders

Study 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 Criteria

Inclusion

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 consentdocument.
Any further criteria listed in the specific disease site subprotocol.
(Esophageal cohort) Patients must be considered appropriate candidates forneoadjuvant chemoradiation therapy followed by esophagectomy. Patients must have anendoscopic ultrasound done or scheduled to be done at the baseline visit.
(Glioblastoma cohort) Patients with a histologically confirmed newly diagnosedintracranial glioblastoma or gliosarcoma who will be undergoing radiation therapy aspart of clinical care.
(Prostate cohort) Patients with localized prostate cancer who are planning toreceive androgen deprivation therapy and definitive radiation therapy.
(Vulvar cohort) Patients with biopsy-proven locally advanced vulvar cancer for whichdefinitive radiotherapy is planned.
(Pediatric glioma cohort) Patients age 18 or under (patients 18-30 years old arealso eligible if the physician determines that based on genetics, the tumor biologyis consistent with pediatric high grade glioma). Patients with a histologicallyconfirmed newly diagnosed high-grade glioma (WHO grade III or IV) who will beundergoing radiation therapy as part of clinical care. Patients with DIPG are onlyeligible if biopsy-confirmed high grade DIPG is present. Ability to understandand/or willingness of their parent or legally authorized representative to sign awritten informed consent document.

Exclusion

Exclusion Criteria:

Disease-specific exclusion criteria will be specified in a subprotocol.
For MRI involving contrast, history of allergic reactions attributed togadolinium-based IV contrast. If patient will not receive contrast, this is notapplicable and kidney function will not affect eligibility.
Inability to undergo magnetic resonance imaging (MRI).

Study Design

MRI IMAGING

January 15, 2020

July 31, 2025

Study 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

Connect with a study center

Brigham and Women Hospital
Boston, Massachusetts 02115
United States
Active - Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts 02215
United States
Active - Recruiting

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