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
Protocol # :
19-573
Conditions
Glioblastoma
Esophageal Cancer
Radiotherapy
Magnetic Resonance Imaging
MRI
Prostate Cancer
Vulvar Cancer
Pediatric Glioblastoma Multiforme
Phase
I
Disease Sites
Esophagus
Brain and Nervous System
Principal Investigator
Leeman, Jonathan

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 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

Eligibility Requirements

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).

19-573