NCT00939315

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jul 2009

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 14, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 15, 2009

Completed
6.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
Last Updated

January 26, 2016

Status Verified

January 1, 2016

Enrollment Period

6.5 years

First QC Date

July 14, 2009

Last Update Submit

January 24, 2016

Conditions

Glioma

Keywords

Glioma, diagnosisImagingPositron emission tomographyMagnetic resonance imagingMagnetic resonance spectroscopy

Outcome Measures

Primary Outcomes (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

    On the biopsy day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with glioma suspicion referred for biopsy to our university hospital

You may qualify if:

  • Suspicion of intracerebral glioma on MR
  • Men of women
  • Age \>18, no upper limit as long as a biopsy or intervention is foreseen

You may not qualify if:

  • Need of rapid intervention in \<2 weeks
  • Previous neurosurgical intervention (biopsy, shunt, etc.) or any other cerebral treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Hospitalier Universitaire Vaudois

Lausanne, CH, 1011, Switzerland

Location

MeSH Terms

Conditions

GliomaDisease

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissuePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John O Prior, PhD MD

    Centre Hospitalier Universitaire Vaudois and University of Lausanne

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Head of Department

Study Record Dates

First Submitted

July 14, 2009

First Posted

July 15, 2009

Study Start

July 1, 2009

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

January 26, 2016

Record last verified: 2016-01

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)