FET-PET/MRI for Surgical Assessment of Pediatric Brain Tumors

NCT03451123•University of Alabama at Birmingham

Summary

The primary objectives of this study are: 1. Determine the percentage of patients whose surgical plan would change with FET-PET/MRI compared to MRI alone. 2. Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI. A secondary objective of this study is: 1\) Perform preliminary correlations between the pre- and post-surgical metabolic tumor volumes measured with FET-PET/MRI to progression free survival.

Eligibility

Age

6 - 18 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient must have a known or suspected primary brain tumor with a non-enhancing component with planned standard of care surgical resection. Patients with newly diagnosed or recurrent brain tumors are eligible.
•2. Tumors with non-enhancing regions will be defined as T2/FLAIR hyperintensity extending at least 0.5 cm beyond areas of enhancement as assessed by MRI.
•3. Patient must be 18 years of age or younger at the time of study enrollment.
•4. Patient must have measurable disease defined as tumor measurable in two perpendicular dimensions on MRI greater than 1 cm.
•5. Patient must have a life expectancy greater than 8 weeks.
•6. Patient must be able to undergo FET-PET/MRI without sedation.
•7. Females with childbearing potential must have a negative urine β-hCG test on the day of procedure or a serum hCG test within 48 hours prior to the administration FET. Females who have not reached menarche will not require pregnancy testing.

Exclusion Criteria

•1. Patient must not be receiving an investigational or standard of care anti-cancer drug within 6 months prior to the FET-PET/MRI study.
•2. Patient must not have received radiation therapy within the past 6 months.
•3. Patient must not have a contraindication to contrast-enhanced MRI (e.g. renal insufficiency, incompatible implant).
•4. Patient must not be pregnant or breast feeding.
•5. Patient must not have been treated for another cancer within 5 years with the exception of cutaneous basal cell carcinoma or squamous cell carcinoma.
•6. Patients must not have a history of brain metastases.

Locations (1)

UAB Advanced Imaging Facility

Birmingham, Alabama, United States

Key Dates

Start Date

April 23, 2018

Primary Completion Date

August 29, 2023

Completion Date

August 29, 2023

Last Updated

December 19, 2023

Enrollment

ACTUAL participants

Conditions

Pediatric Brain Tumors

Interventions

FET PET/MRI

DRUG

Pediatric Radiation Therapy Registry

NCT07129317

SarcomaPediatric Brain Tumors

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 19, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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