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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT04908709
Status
Recruiting

Conditions

  • Malignant Brain Glioma

Eligibility Criteria

Sex
ALL
Age
N/A - 21 Years
Healthy Volunteers
Not accepted

Interventions

  • Magnetic Resonance Spectroscopic Imaging — PROCEDURE
    Undergo sMRI
  • Proton Therapy — DEVICE
    Target volume treatment

Study Details

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.

Key Dates

Start date
Dec 20, 2018
Status verified
Mar 2026
Primary completion
Oct 13, 2029
Completion
Oct 13, 2030

Study Design

Enrollment
25 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Diagnostic (sMRI)
    Patients undergo sMRI over less than 1 hour within 7 days prior to start of standard of care radiation therapy and at 10 weeks.
  • Active Comparator: Group 2
    Patients will undergo 3-4 sMRI scans at baseline prior to RT, 1 month, 4 months, and 7 months after RT, and/or at any time of suspected tumor recurrence.

Primary Outcome Measure

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 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Children's Healthcare of Atlanta - Scottish RiteAtlantaGeorgia30322
Christina Lomba
404-785-4803
Bree R. Eaton (PRINCIPAL_INVESTIGATOR)
Emory Proton Therapy CenterAtlantaGeorgia30308
Ardith R. DeShay
404-251-0753
Bree R. Eaton, MD (PRINCIPAL_INVESTIGATOR)
Emory University Hospital/Winship Cancer InstituteAtlantaGeorgia30322
Hillary Gaines
Bree R. Eaton, MD (PRINCIPAL_INVESTIGATOR)

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