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

Glioma Clinical Trial

— Gliomes-FLP  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00939315
• Other study ID #: 196/08
• Secondary ID: Swissmedic 2009D
• Status: Completed
• Phase: N/A
• First received: July 14, 2009
• Last updated: January 24, 2016
• Start date: July 2009
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Federal Office of Public HealthSwitzerland: Swissmedic
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Glioma

Locations

Country	Name	City	State
Switzerland	Centre Hospitalier Universitaire Vaudois	Lausanne	CH

Sponsors (2)

Lead Sponsor	Collaborator
University of Lausanne Hospitals	Lionel Perrier Foundation (Montreux, Switzerland)

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No