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

This study is not yet open for participant recruitment.

Verified by University Ghent, April 2009

First Received: February 26, 2008 Last Updated: April 6, 2009 History of Changes

Sponsors and Collaborators:	University Ghent FWO BOF
Information provided by:	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

MedlinePlus related topics: Cancer Radiation Therapy

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Safety Study
Official Title:	PET Imaging of High-Grade Glioma Using 18F-Fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?

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:	December 2009
Estimated Study Completion Date:	October 2012
Estimated Primary Completion Date:	October 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental 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
Ghent, Belgium, 9000

Sponsors and Collaborators

University Ghent

FWO

BOF

Investigators

Principal Investigator:

Ingeborg Goethals, MD, PhD

University Hospital, Ghent

More Information

No publications provided

Responsible Party:	University Ghent ( Ingeborg Goethals, MD, PhD )
Study ID Numbers:	2008/085
Study First Received:	February 26, 2008
Last Updated:	April 6, 2009
ClinicalTrials.gov Identifier:	NCT00628940 History of Changes
Health Authority:	Belgium: Federal Agency for Medicinal Products and Health Products

Study placed in the following topic categories:

Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma

Glioma
Recurrence
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:

Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009