Recruiting NCT04313140
Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Diagnostic test.
- Who it may be relevant to
- Registry conditions: Development of the Virtual Biopsy, Tumor Grade, Artificial Intelligence Algorithms, Clinical. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- 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)
Primary outcome measures
- Validation of the virtual biopsy in the context of gliomas through the use of statistical learning algorithms (artificial intelligence) compared to the biopsy. [Time frame: The MRI examination (for 2 hours 30 minutes)]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
France · 1 center
- CHU De Poitiers — Poitiers
Identifiers
NCT: NCT04313140 · 2019-A02531-56