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Recruiting NCT04908709

Spectroscopic MRI Guided Proton Therapy in Assessing Metabolic Change in Pediatric Patients With Brain Tumors

No phase Interventional Malignant Brain Glioma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Magnetic Resonance Spectroscopic Imaging, Proton Therapy.
Who it may be relevant to
Registry conditions: Malignant Brain Glioma. Basic parameters: up to 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Spectroscopic MRI Guided Proton Therapy for Pediatric High-Grade Glioma (RAD4500)

Overview

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.

Interventions

  • Procedure Magnetic Resonance Spectroscopic Imaging
    Undergo sMRI
  • Device Proton Therapy
    Target volume treatment

Primary outcome measures

  • Cho/NAA ratios at baseline in tumor and in regions of tumor recurrence in patients receiving standard of care radiotherapy [Time frame: Through study completion, an average of 1 year]
  • Incidence of adverse events [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 [Time frame: From Baseline up to 3 years from treatment]

Eligibility criteria

Inclusion criteria

  • 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 definitive radiation therapy.
  • Able to receive MRI scans.
  • Both males and females, and members of all races and ethnic groups are eligible for this trial.

Exclusion criteria

  • Patients with pacemakers, non-titanium aneurysm clips, neurostimulators, cochlear implants, non-titanium metal in ocular structures, or other incompatible implants which makes MRI safety an issue are excluded.
  • Patients that have any significant medical illnesses that in the investigator's opinion cannot be adequately tolerate MRI scan are excluded.
  • Pathology demonstrated low-grade glioma or other benign or non-invasive brain tumor.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 3 centers
  • Emory Proton Therapy Center — Atlanta
  • Children's Healthcare of Atlanta - Scottish Rite — Atlanta
  • Emory University Hospital/Winship Cancer Institute — Atlanta

Identifiers

NCT: NCT04908709 · IRB00106849 · NCI-2018-02065 · IRB00106849 · RAD4500-18 · P30CA138292

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗