PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?
This study is currently recruiting participants.
Verified February 2012 by University Ghent
Sponsor:
University Ghent
Collaborators:
FWO, Belgium
Special Research Fund, Belgium
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT00628940
First received: February 26, 2008
Last updated: February 10, 2012
Last verified: February 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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 1 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy? |
Resource links provided by NLM:
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: | January 2010 |
| Estimated Study Completion Date: | October 2012 |
| Estimated Primary Completion Date: | October 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 1
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 | 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, Belgium
Special Research Fund, Belgium
Investigators
| Principal Investigator: | Ingeborg Goethals, MD, PhD | University Hospital, Ghent |
More Information
No publications provided
| Responsible Party: | University Ghent |
| ClinicalTrials.gov Identifier: | NCT00628940 History of Changes |
| Other Study ID Numbers: | 2008/085 |
| Study First Received: | February 26, 2008 |
| Last Updated: | February 10, 2012 |
| Health Authority: | Belgium: Federal Agency for Medicinal Products and Health Products |
Additional relevant MeSH terms:
|
Glioma Recurrence Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Disease Attributes Pathologic Processes |
Choline Lipotropic Agents Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Gastrointestinal Agents Therapeutic Uses Lipid Regulating Agents Nootropic Agents Central Nervous System Agents |
ClinicalTrials.gov processed this record on May 23, 2013