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

NCT ID: NCT04313140

Last Updated: 2023-02-09

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

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-22

Study Completion Date

2026-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Development of the Virtual Biopsy Tumor Grade Artificial Intelligence Algorithms Clinical Radiological

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Patient's Glioma grade

magnetic resonance spectroscopy

Group Type EXPERIMENTAL

Diagnostic test

Intervention Type 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)

Interventions

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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)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Poitiers University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU De Poitiers

Poitiers, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Rémy GUILLEVIN, Pr

Role: CONTACT

05.49.44.45.42

Facility Contacts

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Rémy GUILLEVIN, Pr

Role: primary

05.49.44.45.42

Other Identifiers

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2019-A02531-56

Identifier Type: -

Identifier Source: org_study_id

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