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

ConditionMalignant Brain Neoplasm
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Patient is unable to undergo PET imaging

Persons who are pregnant or nursing

Trial design

Design model

Single group

Treatments tested in this trial

  • Computed Tomography

    Procedure/Surgery

    Undergo PET/CT

  • Fluorodopa F 18

    Drug

    Given IV

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET/CT

Treatment groups

47 Participants
are divided into 1 treatment group
Group A: Diagnostic (18F-DOPA)Experimental treatment 3 interventions

Trial outcomes

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.

Time frame
3 days post-PET scan, up to 64 days

Secondary outcomes

1

Incidence of adverse events

Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

Time frame
3 days post-PET scan, up to 64 days
2

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

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 (including whether a tumor outside of MRI contrast enhancement was identified); 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.

Time frame
3 days post-PET scan, up to 64 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

Food and Drug Administration (FDA)

Collaborator

Source ClinicalTrials.gov
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