Recruiting

Observational Study

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT04188535

Conditions

Glioblastoma

Esophageal Cancer

Radiotherapy

Magnetic Resonance Imaging

MRI

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MRI IMAGING

Study Details

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

Conditions

Glioblastoma

Esophageal Cancer

Radiotherapy

Magnetic Resonance Imaging

MRI

Study ID

NCT04188535

Start date

Jan 15, 2020

Status verified date

Aug, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jul 31, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.
  • (Sarcoma cohort) 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.

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).

Study Design

Enrollment

149 participants

Anticipated

Allocation

Non randomized

Intervention Model

Sequential

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

MRI IMAGING

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

Primary outcome measure

  • Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy [ Time Frame: 1 year ]
  • Ability to measure disease control (for imaging registry expansion cohort) [ Time Frame: 2 years ]

Central Contacts and Locations

Central contacts

Jonathan Leeman, MD

(617) 732-6452JONATHANE_LEEMAN@DFCI.HARVARD.EDU

Locations

Brigham and Women Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Jonathan Leeman, MD

JONATHANE_LEEMAN@DFCI.HARVARD.EDU

Principal Investigator:

Jonathan Leeman, MD

Dana Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Jonathan Leeman, MD

(617) 732-6452JONATHANE_LEEMAN@DFCI.HARVARD.EDU

Principal Investigator:

Jonathan Leeman, MD

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Sep 2, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-09-02.