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

Official title

A Centralized Protocol Evaluating the Safety and Clinical Impact of Amino Acid Pet for Brain Tumors

Overview

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.

Detailed 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.

Interventions

• Procedure Computed Tomography
  Undergo PET/CT
• Drug Fluorodopa F 18
  Given IV
• Procedure Positron Emission Tomography
  Undergo PET/CT

Primary outcome measures

• Impact of 18F-DOPA PET/CT on clinical management [Time frame: 3 days post-PET scan, up to 64 days]

Secondary outcome measures (2)

• Incidence of adverse events [Time frame: 3 days post-PET scan, up to 64 days]
• Rate of identification of tumor outside of standard magnetic resonance imaging (MRI) [Time frame: 3 days post-PET scan, up to 64 days]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Diagnostic

Study locations

United States · 1 center

• Mayo Clinic in Rochester — Rochester

Identifiers

NCT: NCT06667726 · MC250717 · 24-000426 · R01FD007842

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗