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

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.

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Key information

Conditions

Cancer (High-grace Glioma) Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Lions Gate Hospital, North Vancouver, British Columbia, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Surgical neuronavigation with 18F-DOPA PET imaging

Procedure

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 outcomes

The proportion of subjects that have a complete resection of the volume of 18F-FDOPA PET tracer on their postoperative 18F-FDOPA PET scan.

Time frame: Less than 72 hours postoperatively

Sponsors and collaborators

Lead sponsor

Alan Nichol

Other

Registry information

Official study title

A Phase II Study Using 18F-FDOPA Positron Emission Tomography Imaging for Neurosurgery and Assessment of Surgical Resection

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2014
First posted: Nov 25, 2010
Registry last updated: Oct 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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