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

NCT06667726 | Recruiting Phase 2 FDA Drug

• 3 other identifiers: MC25071724-000426R01FD007842
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

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.

Conditions

Malignant Brain Neoplasm

Outcome Measures

Primary Outcomes (1)

• Impact of 18F-DOPA PET/CT on clinical management

  Will be measured using the Amino Acid PET Imaging Survey, to be completed by the provider after participant has received fluorodopa F 18 (18F-DOPA) positron emission tomography (PET)/computed tomography (CT). The survey consists of 4 questions, 1 multiple choice (what will PET scan be used for); 2 yes/no and one open-ended question related with how PET scan did or did not make a clinically meaningful impact in the management of patient care.

  3 days post-PET scan, up to 64 days

Secondary Outcomes (2)

• Incidence of adverse events

  3 days post-PET scan, up to 64 days

• Rate of identification of tumor outside of standard magnetic resonance imaging (MRI)

  3 days post-PET scan, up to 64 days

Study Arms (1)

Diagnostic (18F-DOPA)

EXPERIMENTAL

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

Procedure: Computed Tomography; Drug: Fluorodopa F 18; Procedure: Positron Emission Tomography

Interventions

Positron Emission Tomography PROCEDURE

Undergo PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT

Diagnostic (18F-DOPA)

Computed Tomography PROCEDURE

Undergo PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized axial tomography (procedure), Computerized Tomography, Computerized Tomography (CT) scan, CT, CT Scan, tomography

Diagnostic (18F-DOPA)

Fluorodopa F 18 DRUG

Given IV

Also known as: (18F)FDOPA, 18F-DOPA, 18F-FDOPA, 3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine, 6-(18F)Fluoro-L-DOPA, Fluorine F 18 Fluorodopa, Fluorine-18-fluoro-L-DOPA, Fluorodopa (18F), FLUORODOPA F-18, L-6-(18F)Fluoro-DOPA

Diagnostic (18F-DOPA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Mayo Clinic: lead
• Food and Drug Administration (FDA): collaborator

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Brain Neoplasms

Interventions

fluorodopa F 18; Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Derek R. Johnson, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2024
• First Posted: October 31, 2024
• Study Start: March 24, 2026
• Primary Completion (Estimated): May 31, 2028
• Study Completion (Estimated): May 31, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Locations

US (1)