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

This study is currently recruiting participants.

Verified February 2012 by University Ghent

First Received on February 26, 2008. Last Updated on February 10, 2012 History of Changes

Sponsor:	University Ghent
Collaborators:	FWO, Belgium Special Research Fund, Belgium
Information provided by (Responsible Party):	University Ghent
ClinicalTrials.gov Identifier:	NCT00628940

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 I

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:

MedlinePlus related topics: Cancer

U.S. FDA Resources

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

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
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
Pharmacologic Actions
Gastrointestinal Agents
Therapeutic Uses
Lipid Regulating Agents
Nootropic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 12, 2012