Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging
1 other identifier
interventional
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2021
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2020
CompletedFirst Posted
Study publicly available on registry
March 18, 2020
CompletedStudy Start
First participant enrolled
February 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2026
February 9, 2023
February 1, 2023
5.3 years
March 16, 2020
February 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
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)
Study Arms (1)
Patient's Glioma grade
EXPERIMENTALmagnetic resonance spectroscopy
Interventions
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)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU De Poitiers
Poitiers, France
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2020
First Posted
March 18, 2020
Study Start
February 22, 2021
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
June 1, 2026
Last Updated
February 9, 2023
Record last verified: 2023-02