Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging

February 7, 2023 updated by: Poitiers University Hospital
Glioma is a tumor of the central nervous system. These lesions are sorted with the WHO ranking regarding the tumoral oncotype. The tumoral MRI assessment is the first step before any medical decision. Currently, only anatomical biopsy can give the tumor grade definition and help to define the most adapted treatment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

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 Contact

Study Locations

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:

  • Age≥ 18 years,
  • Patient with suspected glioma with prior imaging
  • Subject free, with legal protection guardianship or curatorship;
  • Enrollment in the French Social Security system;
  • Informed consent signed by the patient

Exclusion Criteria:

  • Any contraindication to an MRI examination
  • Legal protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons residing in a health or social establishment, adults under legal protection and finally patients in emergency situations
  • Pregnant or lactating women, women of childbearing age who do not have effective contraception

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: Patient's Glioma grade
magnetic resonance spectroscopy
Diagnostic test: Diagnostic test

The intervention occurs only one time (for 2h30), the MRI examination is divided as follow:

  • Cinicial MRI (50 minutes)
  • Research MRI (Phosphorus Spectroscopy, Sodium Imaging)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the virtual biopsy in the context of gliomas through the use of statistical learning algorithms (artificial intelligence) compared to the biopsy.
Time Frame: The MRI examination (for 2 hours 30 minutes)
Evaluate the diagnostic capabilities of artificial intelligence algorithms for virtual biopsy based on sensitivity and specificity
The MRI examination (for 2 hours 30 minutes)

Collaborators and Investigators

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

Sponsor

Poitiers University Hospital

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)

February 22, 2021

Primary Completion (ANTICIPATED)

June 1, 2026

Study Completion (ANTICIPATED)

June 1, 2026

Study Registration Dates

First Submitted

March 16, 2020

First Submitted That Met QC Criteria

March 16, 2020

First Posted (ACTUAL)

March 18, 2020

Study Record Updates

Last Update Posted (ESTIMATE)

February 9, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019-A02531-56

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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