Comparison of 6-fluoro-[18F]-L-dihydroxyphenylalanine (18F-DOPA) Positron Emission Tomography (PET) and Multiparametric Resonance Magnetic Imagery (RMI) in Initial Exploration of Glial Tumors (GLIROPA)

January 23, 2020 updated by: Center Eugene Marquis

Diagnostic Assessment Study, Single Site and Prospective, comparing18F-DOPA PET and Multiparametric RMI in Initial Exploration of Diffuse Glial Tumors

For patient having a brain tumor, RMI is the standard exam for tumor characterization and determines initial surgery.

The aim of this study is to assess if PET could provide additional information that could have an impact on surgery (indication and planification)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

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

  • France
    • Bretagne
      • Rennes, Bretagne, France, 35042
        • Centre Eugène Marquis

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

Description

Inclusion Criteria:

  • Suspected glial resectable tumor
  • Free and informed consent
  • Affiliated to French social security

Exclusion Criteria:

  • Suspected high grade glioma
  • Surgical emergency
  • Pregnant or breastfeeding woman
  • Patient deprived of their liberty or under guardianship
  • Patient not able to follow study medical monitoring for geographical, social or psychological reasons
  • Treated with carbidopa, catechol-O-methyl transferase inhibitor, haloperidol, reserpine within 2 weeks before PET imagery

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

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: PET Arm
Diagnostic test: PET imagery
Every patients will have a PET imagery in addition to standard MRI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PET pictures and MRI sequences comparison
Time Frame: Imagings performed up to 29 days after inclusion (before brain surgery)
Comparison of PET pictures and MRI sequences will be done in order to assess concordance between both imagings
Imagings performed up to 29 days after inclusion (before brain surgery)

Collaborators and Investigators

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

Sponsor

Center Eugene Marquis

Investigators

  • Principal Investigator: Florence LE JEUNE, Professor, Centre Eugène Marquis

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 (ACTUAL)

June 12, 2018

Primary Completion (ACTUAL)

September 11, 2019

Study Completion (ACTUAL)

September 11, 2019

Study Registration Dates

First Submitted

May 2, 2018

First Submitted That Met QC Criteria

May 14, 2018

First Posted (ACTUAL)

May 15, 2018

Study Record Updates

Last Update Posted (ACTUAL)

January 27, 2020

Last Update Submitted That Met QC Criteria

January 23, 2020

Last Verified

January 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-4-52-010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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