Multimodal Diagnostic Assessment of Cerebral Gliomas With FET & FCH PET/CT, and Magnetic Resonance Imaging/Spectroscopy (Gliomes-FLP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00939315
Recruitment Status : Completed
First Posted : July 15, 2009
Last Update Posted : January 26, 2016
Lionel Perrier Foundation (Montreux, Switzerland)
Information provided by (Responsible Party):
John O. Prior, 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.

Condition or disease

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 Type : Observational
Actual Enrollment : 51 participants
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
Study Start Date : July 2009
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. 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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with glioma suspicion referred for biopsy to our university hospital

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00939315

Centre Hospitalier Universitaire Vaudois
Lausanne, CH, Switzerland, 1011
Sponsors and Collaborators
University of Lausanne Hospitals
Lionel Perrier Foundation (Montreux, Switzerland)
Principal Investigator: John O Prior, PhD MD Centre Hospitalier Universitaire Vaudois and University of Lausanne

Responsible Party: John O. Prior, Professor and Head of Department, University of Lausanne Hospitals Identifier: NCT00939315     History of Changes
Other Study ID Numbers: 196/08
Swissmedic 2009DR3123 ( Other Identifier: Swissmedic )
First Posted: July 15, 2009    Key Record Dates
Last Update Posted: January 26, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by John O. Prior, University of Lausanne Hospitals:
Glioma, diagnosis
Positron emission tomography
Magnetic resonance imaging
Magnetic resonance spectroscopy

Additional relevant MeSH terms:
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue