Multimodal Diagnostic Assessment of Cerebral Gliomas With FET & FCH PET/CT, and Magnetic Resonance Imaging/Spectroscopy (Gliomes-FLP)
This study is currently recruiting participants.
Verified April 2012 by University of Lausanne Hospitals
Sponsor:
University of Lausanne Hospitals
Collaborator:
Lionel Perrier Foundation (Montreux, Switzerland)
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00939315
First received: July 14, 2009
Last updated: April 16, 2012
Last verified: April 2012
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Purpose
The aim of this study is to establish the diagnostic value of O-(2-[18F]-fluoroethyl)-L-tyrosine (FET) PET-CT, [18F]-fluorocholine (FCH) and magnetic resonance imaging (MRI) combined with magnetic resonance spectroscopy (MRS) in patients with suspected cerebral glioma using neuronavigated biopsies with histopathological analysis as reference. FET combined with MRS may be a powerful, widely applicable new method to improve the diagnosis of cerebral gliomas. The extent to which FCH and MRS provide similar information is not known precisely and this study will establish their respective diagnostic value in differentiating tumoral from non-tumoral tissue.
| Condition |
|---|
|
Glioma |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Impact of Multimodal Diagnostic Assessment of Cerebral Gliomas With F-18-fluoroethyl-L-tyrosine PET/CT, F-18-fluorocholine PET/CT and Magnetic Resonance Imaging and Spectroscopy |
Resource links provided by NLM:
Further study details as provided by University of Lausanne Hospitals:
Primary Outcome Measures:
- Ability of image-guided biopsy using FET, FCH PET/CT and MRS information to target the most representative sites of tumor grade as compared to histopathological examination [ Time Frame: On the biopsy day ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 30 |
| Study Start Date: | July 2009 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients with glioma suspicion referred for biopsy to our university hospital
Criteria
Inclusion Criteria:
- Suspicion of intracerebral glioma on MR
- Men of women
- Age >18, no upper limit as long as a biopsy or intervention is foreseen
Exclusion Criteria:
- Need of rapid intervention in <2 weeks
- Previous neurosurgical intervention (biopsy, shunt, etc.) or any other cerebral treatment
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00939315
Contacts
| Contact: John O Prior, PhD MD | +41 21 314 4348 | john.prior@chuv.ch |
| Contact: Marie Nicod Lalonde, MD | +41 21 314 4373 | marie.nicod@chuv.ch |
Locations
| Switzerland | |
| Centre Hospitalier Universitaire Vaudois | Recruiting |
| Lausanne, CH, Switzerland, 1011 | |
Sponsors and Collaborators
University of Lausanne Hospitals
Lionel Perrier Foundation (Montreux, Switzerland)
Investigators
| Principal Investigator: | John O Prior, PhD MD | Centre Hospitalier Universitaire Vaudois and University of Lausanne |
More Information
No publications provided
| Responsible Party: | John O. Prior, Professor and Head of Department, University of Lausanne Hospitals |
| ClinicalTrials.gov Identifier: | NCT00939315 History of Changes |
| Other Study ID Numbers: | 196/08, Swissmedic 2009DR3123 |
| Study First Received: | July 14, 2009 |
| Last Updated: | April 16, 2012 |
| Health Authority: | Switzerland: Federal Office of Public Health Switzerland: Swissmedic |
Keywords provided by University of Lausanne Hospitals:
|
Glioma, diagnosis Imaging Positron emission tomography Magnetic resonance imaging Magnetic resonance spectroscopy |
Additional relevant MeSH terms:
|
Glioma Neoplasms, Neuroepithelial Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue |
ClinicalTrials.gov processed this record on June 18, 2013