Status:
COMPLETED
Positron Emission Tomography (PET) With 3,4-dihydroxy-6-18F-fluoro-L-enylalanine (18F-FDOPA) Study
Lead Sponsor:
Alan Nichol
Conditions:
Cancer (High-grace Glioma)
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Contrast-enhancing mass on diagnostic brain CT or MRI strongly suggesting a diagnosis of WHO grade III or IV glioma
- Karnofsky Performance status (KPS) ≥ 70
- Age ≥18 years
- Subject is able to understand and consent to study
- Glomerular filtration rate (GFR) ≥ 45 ml/minute
Exclusion
- Indication for urgent craniotomy to relieve mass effect
- Only stereotactic biopsy indicated because tumour is located in eloquent brain.
- 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
- Prior cranial irradiation
- Contra-indications to systemic radiation exposure: pregnancy or breast feeding
- Subject exceeds the weight limit of the PET scanner bed (204.5 kg)
- Subjects taking medication such as Levodopa for the treatment of Parkinson's Disease
- Allergies or other contraindication to CT contrast or MRI contrast
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01248754
Start Date
July 1 2011
End Date
January 1 2014
Last Update
October 20 2016
Active Locations (3)
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1
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
2
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
3
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6