Clinical trial NCT06667726: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Malignant Brain Neoplasm
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2024-10-31
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: 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.

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

Primary outcomes:
measure: Impact of 18F-DOPA PET/CT on clinical management
timeFrame: 3 days post-PET scan, up to 64 days
Secondary outcomes:
measure: Incidence of adverse events
timeFrame: 3 days post-PET scan, up to 64 days
measure: Rate of identification of tumor outside of standard magnetic resonance imaging (MRI)
timeFrame: 3 days post-PET scan, up to 64 days
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Derek R. Johnson, MD
role: PRINCIPAL_INVESTIGATOR
References: