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

Stopped early · Early Phase 1

Conditions studied: Pediatric Brain Tumors

In brief

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.

Key facts

Study ID

NCT03451123

Run by

University of Alabama at Birmingham

People needed

1

Starts

2018-04-23

Expected to finish

2023-08-29

Last updated by the study team

2023-12-19

Who can join

Age: 6 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• 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.
• Patient must be 18 years of age or younger at the time of study enrollment.
• Patient must have measurable disease defined as tumor measurable in two perpendicular dimensions on MRI greater than 1 cm.
• Patient must have a life expectancy greater than 8 weeks.
• Patient must be able to undergo FET-PET/MRI without sedation.
• 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.

You may not qualify if…

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

Where it is running

• UAB Advanced Imaging Facility — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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