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

This study is currently recruiting participants. (see Contacts and Locations)
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 24, 2014