Multimodal Diagnostic Assessment of Cerebral Gliomas With FET & FCH PET/CT, and Magnetic Resonance Imaging/Spectroscopy

Completed

• Conditions: Glioma

• Registration Number: NCT00939315
• Lead Sponsor: University of Lausanne Hospitals

Brief Summary

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.

Detailed Description

The objectives of the study are:

* To demonstrate if the multimodal approach, combining the morphological aspect of the MRI with the metabolic aspect of the tumor with magnetic resonance spectroscopy (MRS) and O-(2-\[18F\]-fluoroethyl)-L-tyrosine (FET) or 18F\]-fluorocholine (FCH) PET/CTthe FCH allows to improve the location of a active metabolic tumor and its impact on the ideal choice of sampling biopsy.

* To underline the differences and similarities between MRS and 18F\]-fluorocholine PET / CT in the assessment of metabolism of the choline. To establish the diagnosis value of both methods, separately and in combination.

* To determine which examinations are useful and complementary for the diagnosis and the management of gliomes.

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.

Study Timeline

• Study Start: 2009-07
• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-14
• Study First Posted: 2009-07-15
• Status Verified: 2016-01
• Primary Completion: 2016-01
• Study Completion: 2016-01
• Last Update Submitted: 2016-01-24
• Last Update Posted: 2016-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	On the biopsy day

Trial Locations

Locations (1)

Centre Hospitalier Universitaire Vaudois; 🇨🇭 Lausanne, CH, Switzerland