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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00939315
First Posted: July 15, 2009
Last Update Posted: January 26, 2016
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.
Collaborator:
Lionel Perrier Foundation (Montreux, Switzerland)
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals
  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.

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 John O. Prior, 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 ]

Enrollment: 51
Study Start Date: July 2009
Study Completion Date: January 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
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
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 ClinicalTrials.gov identifier (NCT number): NCT00939315


Locations
Switzerland
Centre Hospitalier Universitaire Vaudois
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

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 ( Other Identifier: Swissmedic )
First Submitted: July 14, 2009
First Posted: July 15, 2009
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
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


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