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

This study is currently recruiting participants.
Verified April 2013 by British Columbia Cancer Agency
Sponsor:
Information provided by (Responsible Party):
Alan Nichol, British Columbia Cancer Agency
ClinicalTrials.gov Identifier:
NCT01248754
First received: November 24, 2010
Last updated: April 9, 2013
Last verified: April 2013
  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
High-grade Glioma
Procedure: Surgical neuronavigation with 18F-DOPA PET imaging
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: July 2011
Estimated Primary Completion Date: December 2015 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01248754

Contacts
Contact: Alan Nichol, MD 604-877-6000 ext 2380 anichol@bccancer.bc.ca

Locations
Canada, British Columbia
Lions Gate Hospital Not yet recruiting
North Vancouver, British Columbia, Canada, V7L 2L7
Contact: Ramesh Sahjpaul, MD    604-988-3131    ramesh.sahjpaul@vch.ca   
Principal Investigator: Ramesh Sahjpaul, MD         
BC Cancer Agency Recruiting
Vancouver, British Columbia, Canada, V5Z 4E6
Contact: Alan Nichol, MD    604-877-6000 ext 2380    anichol@bccancer.bc.ca   
Principal Investigator: Alan Nichol, MD         
Vancouver General Hospital Recruiting
Vancouver, British Columbia, Canada, V5Z 1M9
Contact: Brian Toyota, MD    604-875-4111    brian.toyota@vch.ca   
Principal Investigator: Brian Toyota, MD         
Sponsors and Collaborators
Alan Nichol
Investigators
Principal Investigator: Alan Nichol, MD British Columbia Cancer Agency
  More Information

Additional Information:
No publications provided

Responsible Party: Alan Nichol, Radiation Oncologist, British Columbia Cancer Agency
ClinicalTrials.gov Identifier: NCT01248754     History of Changes
Other Study ID Numbers: H10-02888
Study First Received: November 24, 2010
Last Updated: April 9, 2013
Health Authority: Canada: Health Canada

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

Additional relevant MeSH terms:
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue

ClinicalTrials.gov processed this record on April 21, 2014