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

Mayo Clinic

Status and phase

Begins enrollment in 2 months

Phase 2

Conditions

Malignant Brain Neoplasm

Treatments

Procedure: Computed Tomography

Procedure: Positron Emission Tomography

Drug: Fluorodopa F 18

Study type

Interventional

Funder types

Other

Identifiers

NCT06667726

24-000426 (Other Identifier)

NCI-2024-08915 (Registry Identifier)

Details and patient eligibility

About

This phase II trial studies how well the addition of 18F-DOPA (amino acid) positron emission tomography (PET)/computed tomography (CT) to standard of care (SOC) imaging can improve the clinical management of patients with brain tumors in over 50% of cases. PET is an imaging test that helps to measure the information about functions of tissues and organs within the body. A PET scan uses a radioactive drug (radiotracer) to show this activity. CT scan uses X-rays to create images of the bones and internal organs within the body. Combining a PET scan with a CT scan can help make the images easier to interpret. PET/CT scans are hybrid scanners that combine both of the two modalities into a single scan. This allows images of both anatomy (CT) and function (PET) to be taken during the same scan. The 18F-DOPA PET/CT scan is done with a very small amount of a radioactive tracer called FDOPA. The PET/CT scan is then used to detect the location of tumors. Using the 18FDOPA-PET/CT scan in addition to the SOC scan may improve the clinical management of patients with brain tumors.

Full description

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.

Enrollment

47 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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