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Trial Title:
An Investigational Scan (18F-DOPA PET/CT) for Improving the Clinical Management of Brain Tumors
NCT ID:
NCT06667726
Condition:
Malignant Brain Neoplasm
Conditions: Official terms:
Brain Neoplasms
Levodopa
Fluorides
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Procedure
Intervention name:
Computed Tomography
Description:
Undergo PET/CT
Arm group label:
Diagnostic (18F-DOPA)
Other name:
CAT
Other name:
CAT Scan
Other name:
Computed Axial Tomography
Other name:
Computerized Axial Tomography
Other name:
Computerized axial tomography (procedure)
Other name:
Computerized Tomography
Other name:
Computerized Tomography (CT) scan
Other name:
CT
Other name:
CT Scan
Other name:
tomography
Intervention type:
Drug
Intervention name:
Fluorodopa F 18
Description:
Given IV
Arm group label:
Diagnostic (18F-DOPA)
Other name:
(18F)FDOPA
Other name:
18F-DOPA
Other name:
18F-FDOPA
Other name:
3-(2-Fluoro-(sup 18)F-4,5-dihydroxyphenyl)-L-alanine
Other name:
6-(18F)Fluoro-L-DOPA
Other name:
Fluorine F 18 Fluorodopa
Other name:
Fluorine-18-fluoro-L-DOPA
Other name:
Fluorodopa (18F)
Other name:
FLUORODOPA F-18
Other name:
L-6-(18F)Fluoro-DOPA
Intervention type:
Procedure
Intervention name:
Positron Emission Tomography
Description:
Undergo PET/CT
Arm group label:
Diagnostic (18F-DOPA)
Other name:
Medical Imaging, Positron Emission Tomography
Other name:
PET
Other name:
PET Scan
Other name:
Positron emission tomography (procedure)
Other name:
Positron Emission Tomography Scan
Other name:
Positron-Emission Tomography
Other name:
proton magnetic resonance spectroscopic imaging
Other name:
PT
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Mayo Clinic in Rochester
Address:
City:
Rochester
Zip:
55905
Country:
United States
Contact:
Last name:
Clinical Trials Referral Office
Phone:
855-776-0015
Email:
mayocliniccancerstudies@mayo.edu
Investigator:
Last name:
Derek R. Johnson, MD
Email:
Principal Investigator
Start date:
November 11, 2024
Completion date:
October 11, 2029
Lead sponsor:
Agency:
Mayo Clinic
Agency class:
Other
Source:
Mayo Clinic
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06667726
https://www.mayo.edu/research/clinical-trials
