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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT06667726
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Mayo Clinic
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Derek R. Johnson, MD
Principal Investigator Affiliation Mayo Clinic in Rochester
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Not yet recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Malignant Brain Neoplasm
Study Website: View Trial Website
Additional Details

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.

Arms & Interventions

Arms

Experimental: Diagnostic (18F-DOPA)

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

Interventions

Procedure: - Computed Tomography

Undergo PET/CT

Drug: - Fluorodopa F 18

Given IV

Procedure: - Positron Emission Tomography

Undergo PET/CT

Contact a Trial Team

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Mayo Clinic in Rochester, Rochester, Minnesota

Status

Address

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

Site Contact

Clinical Trials Referral Office

[email protected]

855-776-0015

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