Back to resultsVirtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging
Primary Purpose
Development of the Virtual Biopsy, Tumor Grade, Artificial Intelligence Algorithms
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Diagnostic test
Sponsored by
About this trial
This is an interventional diagnostic trial for Development of the Virtual Biopsy
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
Sites / Locations
- CHU De PoitiersRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Patient's Glioma grade
Arm Description
magnetic resonance spectroscopy
Outcomes
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.
Evaluate the diagnostic capabilities of artificial intelligence algorithms for virtual biopsy based on sensitivity and specificity
Secondary Outcome Measures
Full Information
NCT ID
NCT04313140
First Posted
March 16, 2020
Last Updated
February 7, 2023
Sponsor
Poitiers University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04313140
Brief Title
Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging
Official Title
Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 22, 2021 (Actual)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Poitiers University Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Development of the Virtual Biopsy, Tumor Grade, Artificial Intelligence Algorithms, Clinical, Radiological
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Patient's Glioma grade
Arm Type
Experimental
Arm Description
magnetic resonance spectroscopy
Intervention Type
Diagnostic Test
Intervention Name(s)
Diagnostic test
Intervention Description
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 Measure Information:
Title
Validation of the virtual biopsy in the context of gliomas through the use of statistical learning algorithms (artificial intelligence) compared to the biopsy.
Description
Evaluate the diagnostic capabilities of artificial intelligence algorithms for virtual biopsy based on sensitivity and specificity
Time Frame
The MRI examination (for 2 hours 30 minutes)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rémy GUILLEVIN, Pr
Phone
05.49.44.45.42
Email
remy.guillevin@chu-poitiers.fr
Facility Information:
Facility Name
CHU De Poitiers
City
Poitiers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rémy GUILLEVIN, Pr
Phone
05.49.44.45.42
Email
remy.guillevin@chu-poitiers.fr
12. IPD Sharing Statement
Learn more about this trial
Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging
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