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

Malignant Brain Glioma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04908709
• Other study ID #: IRB00106849
• Secondary ID: NCI-2018-02065IR
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2018
• Est. completion date: October 13, 2024

Study information

• Verified date: November 2023
• Source: Emory University
• Contact: Bree Eaton, MD
• Phone: 404-778-3473
• Email: brupper[@]emory.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: October 13, 2024
• Est. primary completion date: October 13, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 21 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glioma
• Malignant Brain Glioma

Intervention

Procedure:
• Magnetic Resonance Spectroscopic Imaging
Undergo sMRI

Device:
• Proton Therapy
Target volume treatment

Locations

Country	Name	City	State
United States	Children's Healthcare of Atlanta - Scottish Rite	Atlanta	Georgia
United States	Emory Proton Therapy Center	Atlanta	Georgia
United States	Emory University Hospital/Winship Cancer Institute	Atlanta	Georgia

Sponsors (2)

Lead Sponsor	Collaborator
Emory University	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	Through study completion, an average of 1 year
Primary	Incidence of adverse events	Toxicity will be defined according to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.	Through study completion, an average of 1 year
Primary	Feasibility of using sMRI to define proton therapy high dose (60Gy) target volumes for treatment delivery	Will be estimated by the Kaplan-Meier Method.	From Baseline up to 3 years from treatment