Multimodal Diagnostic Assessment of Cerebral Gliomas With FET & FCH PET/CT, and Magnetic Resonance Imaging/Spectroscopy

NCT ID: NCT00939315

Last Updated: 2016-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

51 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2016-01-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Glioma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Lionel Perrier Foundation (Montreux, Switzerland)

UNKNOWN

Sponsor Role collaborator

University of Lausanne Hospitals

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

John O. Prior

Professor and Head of Department

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

John O Prior, PhD MD

Role: PRINCIPAL_INVESTIGATOR

Centre Hospitalier Universitaire Vaudois and University of Lausanne

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Centre Hospitalier Universitaire Vaudois

Lausanne, CH, Switzerland

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Switzerland

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Swissmedic 2009DR3123

Identifier Type: OTHER

Identifier Source: secondary_id

196/08

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.