Serial MRI Scans During Radiation Therapy for Various Cancers

This study is looking at how useful it is to take several Magnetic Resonance Imaging (MRI) scans during and after standard radiation therapy for people with advanced esophageal cancer, glioblastoma (a type of brain tumor), prostate cancer, vulvar cancer, or pediatric glioma (a type of brain tumor in children). The main goal is to see if it's practical to get these extra MRI scans while you're receiving radiation therapy. Researchers also want to see if these scans can help measure how well the treatment is controlling the disease. You might be able to join if you are 18 or older, need radiation therapy for cancer, and have a good performance status (meaning you can do most daily activities). The study is currently unclear on its recruitment status.

Study design
This is a Phase 1, non-randomized, open-label study. It plans to enroll 149 participants across different cancer types.
What's involved
You would undergo screening for eligibility and have three MRI scans: one before, one during, and one after your standard radiation therapy.
Compensation
Not stated in the trial record.
Follow-up
The study will measure feasibility for 1 year and the ability to measure disease control for 2 years.

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NCT04188535

Serial MRI Scans During Radiation Therapy

Recruiting
NAAges 18+Interventional
Dana-Farber Cancer Institute
~149 participants
Updated 2025-08-26 on ClinicalTrials.gov
What's tested:MRI IMAGING

At a glance

Recruiting sites
2 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy
Measured over 1 year
+1 more outcome measured
Glioblastoma
Esophageal Cancer
Radiotherapy
Magnetic Resonance Imaging
MRI
Prostate Cancer
Vulvar Cancer
Pediatric Glioblastoma Multiforme
2 sites across 1 states
Massachusetts2
  • Jonathan Leeman, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

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Eligibility criteria

Inclusion

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

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).
  • Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy1 year

    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.

  • Ability to measure disease control (for imaging registry expansion cohort)2 years

    Validating a previously developed predictive model to identify the most likely area of recurrence using MRI-based features.