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

Tracking Information

First Received Date ^ICMJE

February 26, 2008

Last Updated Date

April 6, 2009

Start Date ^ICMJE

December 2009

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

time to local recurrence after neurosurgery and adjuvant radiochemotherapy [ Time Frame: 18 months ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00628940 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Diagnostic, Open Label, Single Group Assignment, Safety Study

Condition ^ICMJE

High-Grade Glioma of the Brain

Intervention ^ICMJE

Radiation: PET images with 18F-fluoromethylcholine

Study Arms / Comparison Groups

Experimental: 18F-fluoromethylcholine

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

October 2012

Estimated Primary Completion Date

October 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Ingeborg Goethals, MD, PhD

+32 9 332 54 66

Ingeborg.goethals@ugent.be

Location Countries ^ICMJE

Belgium

Administrative Information

NCT ID ^ICMJE

NCT00628940

Responsible Party

Ingeborg Goethals, MD, PhD, University Ghent

Study ID Numbers ^ICMJE

2008/085

Study Sponsor ^ICMJE

University Ghent

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Ingeborg Goethals, MD, PhD

University Hospital, Ghent

Information Provided By

University Ghent

Verification Date

April 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP