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

October 18, 2016 updated by: Alan Nichol

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • North Vancouver, British Columbia, Canada, V7L 2L7
        • Lions Gate Hospital
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Vancouver General Hospital
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • BC Cancer Agency

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Less than 72 hours postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alan Nichol

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

November 24, 2010

First Submitted That Met QC Criteria

November 24, 2010

First Posted (ESTIMATE)

November 25, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

October 20, 2016

Last Update Submitted That Met QC Criteria

October 18, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • H10-02888

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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