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

NCT ID: NCT00628940

Last Updated: 2018-05-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-12

Study Completion Date

2018-03-22

Brief Summary

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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

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Conditions

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High-grade Glioma of the Brain

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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1

18F-fluoromethylcholine

Group Type EXPERIMENTAL

PET images with 18F-fluoromethylcholine

Intervention Type RADIATION

sequential PET images with 18F-fluoromethylcholine

Interventions

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PET images with 18F-fluoromethylcholine

sequential PET images with 18F-fluoromethylcholine

Intervention Type RADIATION

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Research Foundation Flanders

OTHER

Sponsor Role collaborator

Special Research Fund, Belgium

UNKNOWN

Sponsor Role collaborator

University Ghent

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ingeborg Goethals, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Ghent

Locations

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University Hospital Ghent

Ghent, , Belgium

Site Status

Countries

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Belgium

Other Identifiers

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2008/085

Identifier Type: -

Identifier Source: org_study_id

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