PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?
May 15, 2018 updated by: University Ghent
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
90
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Ghent, Belgium, 9000
- University Hospital Ghent
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 1
18F-fluoromethylcholine
|
sequential PET images with 18F-fluoromethylcholine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
time to local recurrence after neurosurgery and adjuvant radiochemotherapy
Time Frame: 18 months
|
18 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ingeborg Goethals, MD, PhD, University Hospital, Ghent
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 12, 2010
Primary Completion (Actual)
March 14, 2017
Study Completion (Actual)
March 22, 2018
Study Registration Dates
First Submitted
February 26, 2008
First Submitted That Met QC Criteria
February 26, 2008
First Posted (Estimate)
March 5, 2008
Study Record Updates
Last Update Posted (Actual)
May 18, 2018
Last Update Submitted That Met QC Criteria
May 15, 2018
Last Verified
May 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2008/085
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.