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

Clinical Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04313140
• Other study ID #: 2019-A02531-56
• Status: Recruiting
• Phase: N/A
• Start date: February 22, 2021
• Est. completion date: June 2026

Study information

• Verified date: February 2023
• Source: Poitiers University Hospital
• Contact: Rémy GUILLEVIN, Pr
• Phone: 05.49.44.45.42
• Email: remy.guillevin[@]chu-poitiers.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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)

Locations

Country	Name	City	State
France	CHU De Poitiers	Poitiers

Sponsors (1)

Lead Sponsor	Collaborator
Poitiers University Hospital

Country where clinical trial is conducted

France, 

Outcome

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