Using MRI scans to monitor cancer treatment response during radiation therapy
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
This study is testing if regular MRI scans can help doctors see how well radiation therapy is working for patients with advanced cancers like glioblastoma and esophageal cancer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 149 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Boston, Massachusetts and 1 other locations) |
| Trial ID | NCT04188535 on ClinicalTrials.gov |
What this trial studies
This phase 1 study evaluates the feasibility of using serial magnetic resonance imaging (MRI) to assess treatment response in patients undergoing radiation therapy for advanced cancers, including glioblastoma and esophageal cancer. Participants will undergo three MRI scans: one before, one during, and one after their radiation treatment. The study aims to determine how effective this imaging approach is in predicting disease control and treatment outcomes. It includes a prospective imaging registry to explore imaging biomarkers further.
Who should consider this trial
Good fit: Ideal candidates include adults with confirmed malignancies requiring radiation therapy, specifically those with advanced esophageal cancer, glioblastoma, prostate cancer, vulvar cancer, or pediatric glioma.
Not a fit: Patients who do not require radiation therapy or have conditions not included in the specified cohorts may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to monitor treatment responses in real-time, potentially leading to better management of cancer therapies.
How similar studies have performed: While this approach is novel in this specific context, similar studies using MRI for treatment monitoring have shown promise in other cancer types.
Eligibility criteria
Show full inclusion / exclusion 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: * 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).
Where this trial is running
Boston, Massachusetts and 1 other locations
- Brigham and Women Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
Study contacts
- Principal investigator: Jonathan Leeman, MD — Dana-Farber Cancer Institute
- Study coordinator: Jonathan Leeman, MD
- Email: JONATHANE_LEEMAN@DFCI.HARVARD.EDU
- Phone: (617) 732-6452
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.