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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?

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ClinicalTrials.gov Identifier: NCT00628940
Recruitment Status : Unknown
Verified December 2014 by University Ghent.
Recruitment status was:  Recruiting
First Posted : March 5, 2008
Last Update Posted : December 5, 2014
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
High-grade Glioma of the Brain Radiation: PET images with 18F-fluoromethylcholine Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (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?
Study Start Date : January 2010
Estimated Primary Completion Date : October 2015
Estimated Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
18F-fluoromethylcholine
Radiation: PET images with 18F-fluoromethylcholine
sequential PET images with 18F-fluoromethylcholine


Outcome Measures

Primary Outcome Measures :
  1. time to local recurrence after neurosurgery and adjuvant radiochemotherapy [ Time Frame: 18 months ]

Eligibility Criteria

Information from the National Library of Medicine

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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:

  • 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

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): 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

Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT00628940     History of Changes
Other Study ID Numbers: 2008/085
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: December 5, 2014
Last Verified: December 2014

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