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

• Sponsor: Poitiers University Hospital (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04313140
• Collaborator: (none)
• Enrollment: 500
• Location: 1
• Anticipated Duration (Months): 63.2
• Patients Per Site Per Month: 7.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Development of the Virtual Biopsy; Tumor Grade; Artificial Intelligence Algorithms; Clinical; Radiological	Diagnostic Test: Diagnostic test	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 500 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: Single (Participant)
• Primary Purpose: Diagnostic
• Official Title: Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging
• Actual Study Start Date: Feb 22, 2021
• Anticipated Primary Completion Date: Jun 1, 2026
• Anticipated Study Completion Date: Jun 1, 2026

Outcome Measures

Primary Outcome Measures

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU De Poitiers	Poitiers		France

Sponsors and Collaborators

• Poitiers University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Poitiers University Hospital
• ClinicalTrials.gov Identifier: NCT04313140
• Other Study ID Numbers: 2019-A02531-56
• First Posted: Mar 18, 2020
• Last Update Posted: Apr 4, 2022
• Last Verified: Apr 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Glioma

Study Results

No Results Posted as of Apr 4, 2022