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

Not Applicable

Recruiting

• Conditions: Radiological; Development of the Virtual Biopsy; Clinical; Tumor Grade; Artificial Intelligence Algorithms
• Interventions: Diagnostic Test: Diagnostic test

• Registration Number: NCT04313140
• Lead Sponsor: Poitiers University Hospital

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2020-03-16
• Study First Submitted QC: 2020-03-16
• Study First Posted: 2020-03-18
• Study Start: 2021-02-22
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-09
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 500

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patient's Glioma grade	Diagnostic test	magnetic resonance spectroscopy

Primary Outcome Measures

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

Trial Locations

Locations (1)

CHU De Poitiers; 🇫🇷 Poitiers, France