Mayo Clinic
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.
Malignant Brain Neoplasm
Computed Tomography
Fluorodopa F 18
Positron Emission Tomography
PHASE2
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.
| Study Type : | INTERVENTIONAL |
| Estimated Enrollment : | 47 participants |
| Masking : | NONE |
| Primary Purpose : | DIAGNOSTIC |
| Official Title : | A Centralized Protocol Evaluating the Safety and Clinical Impact of Amino Acid Pet for Brain Tumors |
| Actual Study Start Date : | 2025-09-08 |
| Estimated Primary Completion Date : | 2029-10-08 |
| Estimated Study Completion Date : | 2029-10-08 |
Information not available for Arms and Intervention/treatment
| Ages Eligible for Study: | 18 Years |
| Sexes Eligible for Study: | ALL |
| Accepts Healthy Volunteers: |
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Not yet recruiting
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905