Development of the Virtual BiopsyMR3TGLIOBIOPSYNCT04313140
Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging
A study testing Diagnostic test in people with Development of the Virtual Biopsy and Tumor Grade, run by Poitiers University Hospital at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Development of the Virtual Biopsy, Tumor Grade, Artificial Intelligence Algorithms
- What is being tested?
- Diagnostic test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 22 Feb 2021to Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU De Poitiers
Poitiers
Rémy GUILLEVIN, Pr, 05.49.44.45.42, remy.guillevin@chu-poitiers.fr
About this study
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.
- Conditions
- Development of the Virtual Biopsy, Tumor Grade, Artificial Intelligence Algorithms, Clinical, Radiological
- Being tested
- Diagnostic test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnostic testDiagnostic 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)
| Study group | Role | What they receive |
|---|---|---|
| Patient's Glioma grade | Experimental | magnetic resonance spectroscopy Receives: Diagnostic Test: Diagnostic test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: The MRI examination (for 2 hours 30 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start22 Feb 2021
- Primary completionFeb 2029 (estimated)
- Study completionFeb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Development of the Virtual BiopsyStudies of the same condition, open and under way.
- More trials run by Poitiers University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Poitiers University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313140
- Sponsor's protocol ID
- 2019-A02531-56
- Acronym
- MR3TGLIOBIOPSY
- Status last verified
- May 2026
- First submitted
- 16 Mar 2020
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Biopsy Development to Identify Patient's Glioma Grade at the CHU of Poitiers Using Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT04313140
- Acronym / sponsor ID
- MR3TGLIOBIOPSY / 2019-A02531-56
- Conditions
- Development of the Virtual Biopsy, Tumor Grade, Artificial Intelligence Algorithms, Clinical, Radiological
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Poitiers University HospitalUniversity, hospital or other
- Study start
- 22 Feb 2021 (actual)
- Primary completion
- Feb 2029 (estimated)
- Study completion
- Feb 2029 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient's Glioma grade | Experimental | Diagnostic Test: Diagnostic testmagnetic resonance spectroscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnostic testThe intervention occurs only one time (for 2h30), the MRI examination is divided as follow: * Cinicial MRI (50 minutes) * Research MRI (Phosphorus Spectroscopy, Sodium Imaging) | Diagnostic test | Patient's Glioma grade |
Primary outcome
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)
Evaluate the diagnostic capabilities of artificial intelligence algorithms for virtual biopsy based on sensitivity and specificity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Diagnostic test in people with Development of the Virtual Biopsy and Tumor Grade, run by Poitiers University Hospital at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rémy GUILLEVIN, Pr (05.49.44.45.42, remy.guillevin@chu-poitiers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026.