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PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified February 2012 by University Ghent.
Recruitment status was  Recruiting
Sponsor:
Collaborators:
FWO, Belgium
Special Research Fund, Belgium
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT00628940
First received: February 26, 2008
Last updated: February 10, 2012
Last verified: February 2012
  Purpose

The aim of the study is to define preferential sites of tumour recurrence by observing tracer uptake in the tumour in sequential PET images with 18F-fluoromethylcholine (and perfusion MR, see also below). Changes in the intensity of the tracer uptake in the tumour during and after the course of radiotherapy will be correlated with the site of tumour recurrence as will be assessed by conventional MRI. In due time, these results must enable clinicians to change their therapeutic approach of high-grade glioma.


Condition Intervention Phase
High-grade Glioma of the Brain
Radiation: PET images with 18F-fluoromethylcholine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?

Resource links provided by NLM:


Further study details as provided by University Ghent:

Primary Outcome Measures:
  • time to local recurrence after neurosurgery and adjuvant radiochemotherapy [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 20
Study Start Date: January 2010
Estimated Study Completion Date: October 2012
Estimated Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
18F-fluoromethylcholine
Radiation: PET images with 18F-fluoromethylcholine
sequential PET images with 18F-fluoromethylcholine

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years or older
  • patients with high-grade glioma who will undergo adjuvant radiochemotherapy after surgery

Exclusion Criteria:

  • low global performance state
  • pregnancy
  • lactation period
  • presence of pacemaker, vascular clips in the brain ,epidural electrodes, implanted hearing device, set of false theeth attached by means of magnetes, wig attached by means of metal clips
  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: NCT00628940

Contacts
Contact: Ingeborg Goethals, MD, PhD +32 9 332 54 66 Ingeborg.goethals@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Ingeborg Goethals, MD, PhD    +32 9 332 54 66    Ingeborg.goethals@ugent.be   
Principal Investigator: Ingeborg Goethals, MD, PhD         
Sponsors and Collaborators
University Ghent
FWO, Belgium
Special Research Fund, Belgium
Investigators
Principal Investigator: Ingeborg Goethals, MD, PhD University Hospital, Ghent
  More Information

No publications provided

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT00628940     History of Changes
Other Study ID Numbers: 2008/085
Study First Received: February 26, 2008
Last Updated: February 10, 2012
Health Authority: Belgium: Federal Agency for Medicinal Products and Health Products

Additional relevant MeSH terms:
Glioma
Recurrence
Disease Attributes
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Pathologic Processes
Choline
Antimetabolites
Central Nervous System Agents
Gastrointestinal Agents
Hypolipidemic Agents
Lipid Regulating Agents
Lipotropic Agents
Molecular Mechanisms of Pharmacological Action
Nootropic Agents
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on November 27, 2014