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Clinical Trial · NCT03242824
The Utility of 18F-DOPA-PET in the Treatment of Recurrent High-grade Glioma
Overview
This proposal is for a pilot study comparing volumes of 18F-DOPA-PET avidity with contrast enhancement and T2 FLAIR on MRI. Investigators then plan to compare patterns of failure with target volumes, pre-treatment MRI changes and pre-treatment 18F-DOPA-PET.
Sponsor
Mayo Clinic
Phase
Phase 2
Contacts
Nadia N Laack (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT03242824Drug / Compound
Fluorodopa
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- Aromatic L-amino acid decarboxylase (AADC)
Ligand Class: Small Molecules
Eligibility
Inclusion
- Willing to sign consent onto the Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking study, IRB number 15-000136 (blood draw optional)
- Willing to return to enrolling institution for follow-up during Active Monitoring Phase of the study.Exclusion Criteria
- Unable to undergo an 18F-DOPA-PET scan (e.g., Parkinson's Disease, taking anti dopaminergic, or dopamine agonist medication or less than 6 half-lives from discontinuance of dopamine agonists.)Note: Other potentially interfering drugs: amoxapine, amphetamine, benztropine, buproprion, buspirone, cocaine, mazindol, methamphetamine, methylphenidate, norephedrine, phentermine, phenylpropanolamine, selegiline, paroxetine, citalopram, and sertraline). If a patient is on any of these drugs, list which ones on the On-Study form.-Any of the following:
- Inclusion Criteria
- Pregnant women
- History of radiation therapy to the brain for prior diagnosis of glioma
- Unable to undergo MRI scans with contrast
- Nursing women
- Histologically confirmed or radiographic evidence of recurrent/progressive glioma.
- ECOG PS \< or equal to 3
- More than one prior course of radiotherapy or prior prescription doses exceeding 60 Gy to re-irradiation target volumes
- Men or women of childbearing potential who are unwilling to employ adequate contraception
- Planned radiation treatments at Mayo Clinic Rochester
- Provide informed written consent
Exclusion
Exclusion criteria not yet provided.
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