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

Phase 2

Completed

• Conditions: Cancer (High-grace Glioma)
• Interventions: Procedure: Surgical neuronavigation with 18F-DOPA PET imaging

• 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

Study Timeline

• Study First Submitted: 2010-11-24
• Study First Submitted QC: 2010-11-24
• Study First Posted: 2010-11-25
• Study Start: 2011-07
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-18
• Last Update Posted: 2016-10-20

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

Arm && Interventions

Group	Intervention	Description
18F-DOPA PET imaging	Surgical neuronavigation with 18F-DOPA PET imaging	Subjects will undergo preoperative 18F-FDOPA PET imaging, which will be used in neuronavigation software to guide resection of their high-grade glioma. Postoperative 18F-FDOPA PET imaging will be obtained to determine the extent of resection.

Primary Outcome Measures

Name	Time	Method
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

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