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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 21
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Magnetic Resonance Spectroscopic Imaging

    Procedure/Surgery

    Undergo sMRI

  • Proton Therapy

    Device

    Target volume treatment

Treatment groups

25 Participants
are divided into 2 treatment groups
Group A: Diagnostic (sMRI)Experimental treatment 2 interventions
Group B: Group 2Active comparator 2 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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

Secondary outcomes

Other outcomes

Sponsors and contacts

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Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator