Serial MRI Scans During Radiation Therapy

NCT ID: NCT04188535

Last Updated: 2025-08-26

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 149 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-01-15
• Study Completion Date: 2030-07-31

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 149 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
• 10 participants in the sarcoma cohort

Conditions

Glioblastoma; Esophageal Cancer; Radiotherapy; Magnetic Resonance Imaging; MRI; Prostate Cancer; Vulvar Cancer; Pediatric Glioblastoma Multiforme

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

MRI IMAGING

Intervention Type: DIAGNOSTIC_TEST

Imaging with MRI will be performed as per disease site standards.

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.

Group Type: EXPERIMENTAL

MRI IMAGING

Intervention Type: DIAGNOSTIC_TEST

Imaging with MRI will be performed as per disease site standards.

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.

Group Type: EXPERIMENTAL

MRI IMAGING

Intervention Type: DIAGNOSTIC_TEST

Imaging with MRI will be performed as per disease site standards.

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

Group Type: EXPERIMENTAL

MRI IMAGING

Intervention Type: DIAGNOSTIC_TEST

Imaging with MRI will be performed as per disease site standards.

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

Group Type: EXPERIMENTAL

MRI IMAGING

Intervention Type: DIAGNOSTIC_TEST

Imaging with MRI will be performed as per disease site standards.

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.

Group Type: EXPERIMENTAL

MRI IMAGING

Intervention Type: DIAGNOSTIC_TEST

Imaging with MRI will be performed as per disease site standards.

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.

Group Type: EXPERIMENTAL

MRI IMAGING

Intervention Type: DIAGNOSTIC_TEST

Imaging with MRI will be performed as per disease site standards.

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.

Group Type: EXPERIMENTAL

MRI IMAGING

Intervention Type: DIAGNOSTIC_TEST

Imaging with MRI will be performed as per disease site standards.

Interventions

MRI IMAGING

Imaging with MRI will be performed as per disease site standards.

Intervention Type: DIAGNOSTIC_TEST

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

• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Leeman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Leeman, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

Brigham and Women Hospital

Boston, Massachusetts, United States

Site Status: RECRUITING

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Jonathan Leeman, MD

Role: CONTACT

JONATHANE_LEEMAN@DFCI.HARVARD.EDU

(617) 732-6452

Facility Contacts

Jonathan Leeman, MD

Role: primary

JONATHANE_LEEMAN@DFCI.HARVARD.EDU

Jonathan Leeman, MD

Role: primary

JONATHANE_LEEMAN@DFCI.HARVARD.EDU

(617) 732-6452

Other Identifiers

19-573

Identifier Type: -

Identifier Source: org_study_id