Malignant Brain Neoplasm
Conditions
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.
Interventions
PROCEDUREComputed Tomography
Undergo PET/CT
DRUGFluorodopa F 18
Given IV
PROCEDUREPositron Emission Tomography
Undergo PET/CT
Sponsors
Mayo Clinic
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Impact of 18F-DOPA PET/CT on clinical management | 3 days post-PET scan, up to 64 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of adverse events | 3 days post-PET scan, up to 64 days | Will be assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0. |
| Rate of identification of tumor outside of standard magnetic resonance imaging (MRI) | 3 days post-PET scan, up to 64 days | 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. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORDerek R. Johnson, MD
Mayo Clinic in Rochester
Outcome results
None listed