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

January 24, 2016 updated by: John O. Prior, University of Lausanne Hospitals

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

51

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • CH
      • Lausanne, CH, Switzerland, 1011
        • Centre hospitalier universitaire vaudois

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with glioma suspicion referred for biopsy to our university hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
On the biopsy day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Lausanne Hospitals

Collaborators

Lionel Perrier Foundation (Montreux, Switzerland)

Investigators

  • Principal Investigator: John O Prior, PhD MD, Centre Hospitalier Universitaire Vaudois and University of Lausanne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

July 14, 2009

First Submitted That Met QC Criteria

July 14, 2009

First Posted (Estimate)

July 15, 2009

Study Record Updates

Last Update Posted (Estimate)

January 26, 2016

Last Update Submitted That Met QC Criteria

January 24, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 196/08
  • Swissmedic 2009DR3123 (Other Identifier: Swissmedic)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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