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MeningiomaMENTHENCT04113408

MEningioma Detection Using Non Contrast MRI TecHniquEs

An observational study of Meningioma, run by Fondation Ophtalmologique Adolphe de Rothschild at 1 site in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

Meningioma, an extra-axial brain tumor developed at the expense of meninges, accounts for 35% of central nervous system tumors, and its incidence is estimated at 3% in large autopsy series. The current gold standard for screening and monitoring cerebral meningiomas is MRI with injection of gadoline-contrast product. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Meningioma
What is being tested?
FABIR sequence
How many people
315 participants
Where
1 siteFrance
Study dates
12 Jun 2020to 2 Jun 2025
Phase
Observational
Are there results?
None posted in the registry

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

Study population: Patients presenting to the radiology department of the A. de Rothschild Foundation for an MRI, as part of a screening or monitoring of meningioma

Who may be able to join

  • Patient over 18 years of age
  • Patient performing MRI as part of a screening or follow-up of known meningioma
  • Express consent to participate in the study

Who cannot join

  • Contraindication for MRI (electrical device, metallic foreign body, claustrophobia)
  • Known hypersensitivity to the contrast medium (Gadolinium)
  • Known renal failure: glomerular filtration rate <30mL/min
  • Patient benefiting from a legal protection measure
  • Pregnant or breastfeeding woman

Trial locations and contacts

1 site in 1 country.

France1 site
  • Fondation ophtalmique Adolphe de Rothschild

    Paris, Paris, 75019

Other trials in France

About this study

Meningioma, an extra-axial brain tumor developed at the expense of meninges, accounts for 35% of central nervous system tumors, and its incidence is estimated at 3% in large autopsy series.

The current gold standard for screening and monitoring cerebral meningiomas is MRI with injection of gadoline-contrast product. However, the use of some of these products is problematic, due to gadolinium deposits observed in patients who have had several injections during their lifetime, especially in patients followed for multiple sclerosis.

Read more

Recently, the French National Agency for the Safety of Medicines and Health Products (ANSM) issued recommendations concerning the screening of meningiomas in patients at risk, particularly in people treated with cyproterone acetate. It is a synthetic progestogen steroid with anti-androgenic properties. It is used to treat hyperandrogenic syndromes in women or in the palliative treatment of prostate cancer in men. Its long-term use seems to be associated with a significant over-risk of developing meningiomas, brain tumours affecting meninges. This increased risk is multiplied by 7 in women exposed to high doses of cyproterone acetate, and by 20 over a cumulative dose of 60 grams, or about 5 years of treatment at 50 mg/day or 10 years at 25 mg/day. The ANSM recommends that a cerebral MRI be performed at the beginning of treatment for all patients, as well as a control MRI renewed at 5 years and then every 2 years if the MRI at 5 years is normal. These recommendations will lead to a large number of MRIs involving an injection of contrast agent in this population, with potential immediate or delayed serious adverse effects.

New techniques, such as Arterial Spin Labelling (ASL), or black blood sequences optimized for contrast detection, have been developed. These could detect meningeal anomalies and more particularly meningiomas without contrast injection, or with a significantly lower dose of contrast agent.

These techniques have not been specifically studied for screening or monitoring meningeal lesions, but it seems relevant and important to be able to validate protocols that reduce gadolinium doses given the high number of screening and follow-up MRIs in the general population.

Patients presenting for brain MRI for meningioma screening or follow-up will have the usual MRI sequences for their management, and the FABIR sequences without injection, added for research. These new sequences will add approximately 8 minutes of additional examination time.

Conditions
Meningioma
Being tested
FABIR sequence
Medical subject headings
Meningioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FABIR sequenceOther

    The FABIR sequence with a duration of 8 minutes is added to the imaging protocol.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the diagnostic concordance in terms of detection of cerebral meningiomas between the usual MRI sequences (Gold Standard) and the FABIR sequences without Gadolinium injection, performed as part of a meningioma screening or follow-up.

    Measured: 1 day

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Oct 2019
  2. Study start12 Jun 2020
  3. Primary completion2 Jun 2025
  4. Study completion2 Jun 2025

Why it stopped: The study was discontinued due to lack of inclusion.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case only
Time perspective
Prospective
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04113408
Sponsor's protocol ID
ALR_2019_15
Acronym
MENTHE
Status last verified
Dec 2025
First submitted
1 Oct 2019
Last updated
6 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

An observational study of Meningioma, run by Fondation Ophtalmologique Adolphe de Rothschild 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 3 inclusion and 5 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: stopped early, as of the sponsor's last update on 6 Jan 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?

The study was stopped early (reason given: The study was discontinued due to lack of inclusion.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the diagnostic concordance in terms of detection of cerebral meningiomas between the usual MRI sequences (Gold Standard) and the FABIR sequences without Gadolinium injection, performed as part of a meningioma screening or follow-up. (time frame: 1 day). 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 6 Jan 2026.

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