Spectroscopic MRI Guided Proton Therapy for Pediatric High-Grade Glioma (RAD4500)
Summary
This trial studies how well spectroscopic magnetic resonance imaging (MRI) guided proton therapy works in assessing metabolic change in pediatric patients with brain tumors. The non-invasive imaging, such as spectroscopic MRI may help to map the differences in tumor metabolism compared to healthy tissue without injection of any contrast agent.
Detailed description
PRIMARY OBJECTIVES: I. To obtain spectroscopic (s)MRI data from pediatric high grade glioma (HGG) patients before receiving standard of care radiation therapy (RT) and correlate baseline Cho/NAA ratios to recurrence patterns. (Cohort 1, observational) II. To assess the feasibility and safety of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery. (Cohort 2, intervention) SECONDARY OBJECTIVES: I. To evaluate how Cho/NAA defined radiation target volumes compare to standard of care radiation target volumes in size and resulting radiation delivery to adjacent normal tissue, by creating mock comparison RT plans for each patient. II. To compare voxel-to-voxel changes in pre-treatment and post-treatment sMRI and evaluate as potential early predictor of tumor response/recurrence. III. To evaluate sMRI as a tool in identifying pseudoprogression vs. true progression and correlate post-treatment sMRI metabolite ratios with histopathology if collected. IV. To report patterns of failure in relationship to the RT field (local, marginal, or distant), progression-free survival (PFS) and overall survival (OS) among all patients. V. To report patient reported outcomes of health related quality of life (QOL) during and after proton therapy for pediatric HGG. VI. To build a longitudinal tracking database including clinical data, imaging, and genomic molecular profiling for pediatric HGG treatment. OUTLINE: Patients undergo sMRI prior to radiation therapy, at 1, 4, and 7 months after RT, and at the time of suspected recurrence.
Arms & interventions
- ProcedureMagnetic Resonance Spectroscopic Imaging
Undergo sMRI
- DeviceProton Therapy
Target volume treatment
Outcome measures
Primary
Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy
The spatial relationship between baseline sMRI abnormalities and tumor recurrence will be reported and proportion of overlap will be quantified.
Time frame: Through study completion, an average of 1 year
Incidence of adverse events
Toxicity will be defined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.
Time frame: Through study completion, an average of 1 year
Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery
Will be estimated by the Kaplan-Meier Method.
Time frame: From Baseline up to 3 years from treatment
Eligibility criteria
Study locations (3)
Emory Proton Therapy Center
Atlanta, Georgia, 30308
Children's Healthcare of Atlanta - Scottish Rite
Atlanta, Georgia, 30322
Emory University Hospital/Winship Cancer Institute
Atlanta, Georgia, 30322