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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 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.
 
ClinicalTrials.gov Identifier: NCT00628940
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : May 18, 2018
Sponsor:
Collaborators:
Research Foundation Flanders
Special Research Fund, Belgium
Information provided by (Responsible Party):
University Ghent

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: N/A
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?
Actual Study Start Date : January 12, 2010
Actual Primary Completion Date : March 14, 2017
Actual Study Completion Date : March 22, 2018

Resource links provided by the National Library of Medicine


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




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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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

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


Locations
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Belgium
University Hospital Ghent
Ghent, Belgium, 9000
Sponsors and Collaborators
University Ghent
Research Foundation Flanders
Special Research Fund, Belgium
Investigators
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Principal Investigator: Ingeborg Goethals, MD, PhD University Hospital, Ghent
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Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT00628940    
Other Study ID Numbers: 2008/085
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: May 18, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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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