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

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, February 2008

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

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:	October 2008
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	Not yet 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

BOF

Investigators


Principal Investigator:	Ingeborg Goethals, MD, PhD	University Hospital, Ghent

More Information

Responsible Party:	University Ghent ( Ingeborg Goethals, MD, PhD )
Study ID Numbers:	2008/085
First Received:	February 26, 2008
Last Updated:	February 26, 2008
ClinicalTrials.gov Identifier:	NCT00628940
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:

Neoplasms

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Neoplasms, Neuroepithelial

ClinicalTrials.gov processed this record on August 21, 2008