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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

Enrolling

Trial ID:NCT04188535

View complete trial on ClinicalTrials.gov

Protocol #:19-573

877-DF-TRIAL (877-338-7425)

Condition(s):Esophageal Cancer, Glioblastoma, Magnetic Resonance Imaging, MRI, Pediatric Glioblastoma Multiforme, Prostate Cancer, Radiotherapy, Vulvar Cancer

Phase:I

Principal Investigator:Leeman, Jonathan

Site Research Nurse(s):Spicer, Beverly, A.

Trial Description:
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 pre treatment, during and post standard 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 Requirements:
- Participants must have a confirmed malignancy requiring radiation therapy.
- Age: 18 years or older
- ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
- Ability to understand and the willingness to sign a written informed consent document.
- Any further criteria listed in the specific disease site sub protocol
- Patients must be considered appropriate candidates for neoadjuvant chemoradiation therapy followed by esophagectomy
- Patients with a histologically confirmed newly diagnosed intracranial glioblastoma or gliosarcoma who will be undergoing radiation therapy as part of clinical care.
- Patients with localized prostate caner who are planned to receive androgen deprivation therapy and definitive radiation therapy.
- Patients with Biopsy-proven locally advanced vulvar cancer for which definitive radiotherapy is planned
- Patients who are age 18 or under (or 18-30 if physician determines that biology is consistent with pediatric high grade glioma) 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.
Exclusion Criteria
- Disease-specific exclusion criteria will be specified in a sub protocol.
- For MRI involving contrast, history of allergic reactions attributed to gadolinium based IV contrast.
-- Note: If patient will not receive contrast, this is not applicable and kidney function will not affect eligibility
- Unable to undergo magnetic resonance imaging (MRI)

Protocol #: 19-573

Questions & Enrollment
877-DF-TRIAL
(877-338-7425)