An Investigational Scan (18F-DOPA PET/CT) for Improving the Clinical Management of Brain Tumors

PRIMARY OBJECTIVE:

I. To determine whether the addition of amino acid PET to standard of care imaging impacts clinical management of brain tumor patients in over 50% of cases.

SECONDARY OBJECTIVES:

I. To assess the safety and tolerability of amino acid PET for brain tumor patients in response to Food and Drug Administration (FDA) guidance that such data is needed to support a potential New Drug Application (NDA) for fluorodopa F 18 (18F-DOPA).

II. To assess the rate of identification of tumor outside of standard magnetic resonance imaging (MRI) imaging.

OUTLINE:

Patients receive 18F-DOPA intravenously (IV) and undergo PET/CT over 30 minutes on day 1.

After completion of study intervention, patients are followed for 3 days.

Inclusion criteria

• Age 18 and older
• Diagnosis of a brain tumor
• Indication for amino acid PET imaging, including presurgical evaluation, radiation planning, MR imaging indeterminate for progression versus treatment effect, or clinical need for enhanced monitoring
• Ability to give appropriate consent or have an appropriate representative available to do so

Exclusion criteria

• Patient is unable to undergo PET imaging
• Persons who are pregnant or nursing