Back to resultsPET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?
Primary Purpose
High-grade Glioma of the Brain
Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
PET images with 18F-fluoromethylcholine
Sponsored by
About this trial
This is an interventional diagnostic trial for High-grade Glioma of the Brain
Eligibility 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
Sites / Locations
- University Hospital Ghent
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
18F-fluoromethylcholine
Outcomes
Primary Outcome Measures
time to local recurrence after neurosurgery and adjuvant radiochemotherapy
Secondary Outcome Measures
Full Information
NCT ID
NCT00628940
First Posted
February 26, 2008
Last Updated
May 15, 2018
Sponsor
University Ghent
Collaborators
Research Foundation Flanders, Special Research Fund, Belgium
1. Study Identification
Unique Protocol Identification Number
NCT00628940
Brief Title
PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?
Official Title
PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?
Study Type
Interventional
2. Study Status
Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 12, 2010 (Actual)
Primary Completion Date
March 14, 2017 (Actual)
Study Completion Date
March 22, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Research Foundation Flanders, Special Research Fund, Belgium
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-grade Glioma of the Brain
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
18F-fluoromethylcholine
Intervention Type
Radiation
Intervention Name(s)
PET images with 18F-fluoromethylcholine
Intervention Description
sequential PET images with 18F-fluoromethylcholine
Primary Outcome Measure Information:
Title
time to local recurrence after neurosurgery and adjuvant radiochemotherapy
Time Frame
18 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingeborg Goethals, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
12. IPD Sharing Statement
Learn more about this trial
PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?
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