Spectroscopic MRI Guided Proton Therapy in Assessing Metabolic Change in Pediatric Patients with Brain Tumors
Brain & Spinal Cord Tumor
Unknown Primary
0 - 21 Years, Male and Female
RAD4500-18 (primary)
NCI-2018-02065
IRB00106849
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.
Objectives
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. Patients also undergo MRI at baseline, at 1, 4, 7, 10 and every 3 months after RT.
Eligibility
- Age = 21 years old at the time of registration.
- Pathologically diagnosed high-grade glioma (World Health Organization [WHO] grade 3-4). Patients with a radiographically diagnosed high-grade glioma may enroll prior to pathologic confirmation, but would be removed from study if pathology did not confirm the diagnosis of high-grade glioma.
- Primary tumor located within the supratentorial brain.
- Recommended to receive radiation therapy.
- Able to receive MRI scans.
- Both males and females, and members of all races and ethnic groups are eligible for this trial.
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