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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by University of Lausanne Hospitals.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Lionel Perrier Foundation (Montreux, Switzerland)
Information provided by (Responsible Party):
John O. Prior, University of Lausanne Hospitals
ClinicalTrials.gov Identifier:
NCT00939315
First received: July 14, 2009
Last updated: April 16, 2012
Last verified: April 2012
  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. 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.


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 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: July 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00939315

Contacts
Contact: John O Prior, PhD MD +41 21 314 4348 john.prior@chuv.ch
Contact: Marie Nicod Lalonde, MD +41 21 314 4373 marie.nicod@chuv.ch

Locations
Switzerland
Centre Hospitalier Universitaire Vaudois Recruiting
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

No publications provided

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
Study First Received: July 14, 2009
Last Updated: April 16, 2012
Health Authority: Switzerland: Federal Office of Public Health
Switzerland: Swissmedic

Keywords provided by University of Lausanne Hospitals:
Glioma, diagnosis
Imaging
Positron emission tomography
Magnetic resonance imaging
Magnetic resonance spectroscopy

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

ClinicalTrials.gov processed this record on October 23, 2014