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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01248754
First Posted: November 25, 2010
Last Update Posted: October 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Alan Nichol, British Columbia Cancer Agency
  Purpose
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.

Condition Intervention Phase
Cancer (High-grace Glioma) Procedure: Surgical neuronavigation with 18F-DOPA PET imaging Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase II Study Using 18F-FDOPA Positron Emission Tomography Imaging for Neurosurgery and Assessment of Surgical Resection

Resource links provided by NLM:


Further study details as provided by Alan Nichol, British Columbia Cancer Agency:

Primary Outcome Measures:
  • 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 ]

Enrollment: 20
Study Start Date: July 2011
Study Completion Date: January 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01248754


Locations
Canada, British Columbia
Lions Gate Hospital
North Vancouver, British Columbia, Canada, V7L 2L7
Vancouver General Hospital
Vancouver, British Columbia, Canada, V5Z 1M9
BC Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Sponsors and Collaborators
Alan Nichol
Investigators
Principal Investigator: Alan Nichol, MD British Columbia Cancer Agency
  More Information

Additional Information:
Responsible Party: Alan Nichol, Radiation Oncologist, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01248754     History of Changes
Other Study ID Numbers: H10-02888
First Submitted: November 24, 2010
First Posted: November 25, 2010
Last Update Posted: October 20, 2016
Last Verified: October 2016

Keywords provided by Alan Nichol, British Columbia Cancer Agency:
Neurosurgery
Neuronavigation
Positron emission tomography
FDOPA

Additional relevant MeSH terms:
Dihydroxyphenylalanine
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs