About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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).
Trial design
Sequential
Treatments tested in this trial
MRI IMAGING
Diagnostic testImaging with MRI will be performed as per disease site standards.
Treatment groups
8
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
Feasibility of acquiring serial MRI scans on an MRI simulator during treatment with radiation therapy
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)
Validating a previously developed predictive model to identify the most likely area of recurrence using MRI-based features.
Secondary outcomes
Dosimetric change
For subprotocols studying the adaptive treatment, the secondary objective is dosimetric change in the in silico adaptive radiation therapy plans, without delivering adaptive plans in Phase I.
Sponsors and contacts
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