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

Status: complete

This early phase I trial studies the use of FET-positron emission tomography (PET)/magnetic resonance imaging (MRI) in imaging children with newly diagnosed brain tumor or brain tumor that has come back. FET is radioactive drug that is taken up by tumor cells. FET is similar to the natural amino acid tyrosine. The radioactive part of the drug is fluorine-18 which allows scientist to see the amount of FET in the brain and in brain tumors over time. Brain tumors take up more amino acids than normal brain tissue, allowing scientist to see the tumor using PET. PET is a type of imaging test that uses a small amount of radioactive drug injected into the vein to see how cells or tissues are functioning. PET can be combined with a MRI machine which uses magnetic fields and radio waves to generate images of the inside of the body. Diagnostic procedures such as FET-PET/MRI may change the surgical plan and detect remaining brain tumor after surgery.

Inclusion Criteria

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 6 to 18 years of age 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 beta-human chorionic gonadotropin (hCG) test on the day of procedure or a serum beta-hCG test within 48 hours prior to the administration FET. Females who have not reached menarche will not require pregnancy testing

Exclusion Criteria

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 to the brain within 6 months prior to the FET-PET/MRI study
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

PRIMARY OBJECTIVES:

I. Determine the percentage of patients whose surgical plan would change with F-18 fluoroethyltyrosine (FET)-PET/MRI compared to MRI alone.

II. Determine the percentage of patients who have residual tumor after surgery detected with FET-PET/MRI.

SECONDAY OBJECTIVE:

I. Perform preliminary correlations between the pre- and post-surgical metabolic tumor volumes measured with FET-PET/MRI to progression free survival.

OUTLINE:

Patients receive F-18 fluoroethyltyrosine intravenously (IV) over 30 seconds and undergo PET/MRI over 60 minutes before surgery and within 48 hours after surgical resection.

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

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