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Clinical Trial · NCT01248754
Positron Emission Tomography (PET) With 3,4-dihydroxy-6-18F-fluoro-L-enylalanine (18F-FDOPA) Study
Overview
The 18F-FDOPA PET tracer is an amino acid analogue that can be used to visualize high-grade glioma not clearly identified on diagnostic MRI. Use of 18F-FDOPA PET will permit neurosurgeons to achieve a complete resection more frequently.
Sponsor
British Columbia Cancer Agency
Phase
Phase 2
Contacts
Alan Nichol, MD (PRINCIPAL_INVESTIGATOR)
ClinicalTrials.gov
NCT01248754Drug / Compound
FDOPA
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
- Karnofsky Performance status (KPS) ≥ 70
- Glomerular filtration rate (GFR) ≥ 45 ml/minute
- Subject is able to understand and consent to study
Exclusion
- Indication for urgent craniotomy to relieve mass effect
- The enhancement on the T1 MRI sequence involves or abuts the basal ganglia
- Previous intracranial malignancy or any invasive malignancy unless free of disease \> 5 years
- Contra-indications to systemic radiation exposure: pregnancy or breast feeding
- Allergies or other contraindication to CT contrast or MRI contrast
- Only stereotactic biopsy indicated because tumour is located in eloquent brain.
- Subjects taking medication such as Levodopa for the treatment of Parkinson's Disease
- Prior cranial irradiation
- Subject exceeds the weight limit of the PET scanner bed (204.5 kg)
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