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Positron Emission Tomography (PET) With 3,4-dihydroxy-6-18F-fluoro-L-enylalanine (18F-FDOPA) Study

Phase 2
Completed
Conditions
Cancer (High-grace Glioma)
Registration Number
NCT01248754
Lead Sponsor
Alan Nichol
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 complete resection more frequently.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria
  • 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 Criteria
  • 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

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Primary Outcome Measures
NameTimeMethod
The proportion of subjects that have a complete resection of the volume of 18F-FDOPA PET tracer on their postoperative 18F-FDOPA PET scan.Less than 72 hours postoperatively
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Lions Gate Hospital

🇨🇦

North Vancouver, British Columbia, Canada

Vancouver General Hospital

🇨🇦

Vancouver, British Columbia, Canada

BC Cancer Agency

🇨🇦

Vancouver, British Columbia, Canada

Lions Gate Hospital
🇨🇦North Vancouver, British Columbia, Canada

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