Clinical trial NCT00939315: Multimodal Diagnostic Assessment of Cerebral Gliomas With FET & FCH PET/CT, and Magnetic Resonance Imaging/Spectroscopy
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glioma
Keywords: Glioma, diagnosis
Imaging
Positron emission tomography
Magnetic resonance imaging
Magnetic resonance spectroscopy
Lead sponsor: University of Lausanne Hospitals
Sponsor class: OTHER
Collaborators: name: Lionel Perrier Foundation (Montreux, Switzerland)
First posted: 2009-07-15
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with glioma suspicion referred for biopsy to our university hospital

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.

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: On the biopsy day
Secondary outcomes:
Other outcomes:
Locations:
city: Lausanne
country: Switzerland
facility: Centre Hospitalier Universitaire Vaudois
state: CH
Study officials:
affiliation: Centre Hospitalier Universitaire Vaudois and University of Lausanne
name: John O Prior, PhD MD
role: PRINCIPAL_INVESTIGATOR
References: