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Concordance and Accuracy of MRI in the Detection of Meningiomas: Optimizing Sequences With Low Doses of Gadolinium

Study Purpose

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. 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 screening or meningioma follow-up will have the usual MRI sequences for their management, and the sequences performed at 1/6th of the standard dose of Gadolinium that are added for research. These new sequences will add approximately 6 minutes of additional examination time.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - 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.

Exclusion Criteria:

  • - 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 Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04113395
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Fondation Ophtalmologique Adolphe de Rothschild
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries France
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Meningioma

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

CHU de Bordeaux, Bordeaux, France

Status

Not yet recruiting

Address

CHU de Bordeaux

Bordeaux, , 33076

Site Contact

Patrice MENEGON

[email protected]

0148036454

CHU de Grenoble, Grenoble, France

Status

Recruiting

Address

CHU de Grenoble

Grenoble, , 38100

Site Contact

Sylvie Grand

[email protected]

0148036454

CHU de Limoges, Limoges, France

Status

Recruiting

Address

CHU de Limoges

Limoges, , 87042

Site Contact

Aymeric ROUCHAUD

[email protected]

0148036454

CHU de Lyon, Lyon, France

Status

Recruiting

Address

CHU de Lyon

Lyon, , 69495

Site Contact

François Cotton

[email protected]

0148036454

CHU de Nantes, Nantes, France

Status

Recruiting

Address

CHU de Nantes

Nantes, , 44800

Site Contact

Jesus GARCIA

[email protected]

0148036454

Paris, France

Status

Recruiting

Address

Fondation ophtalmique Adolphe de Rothschild

Paris, , 75019

Site Contact

Augustin Lecler, MD

[email protected]

0148036454

CHU de Rennes, Rennes, France

Status

Not yet recruiting

Address

CHU de Rennes

Rennes, , 35033

Site Contact

Béatrice CARSIN-NICOL

[email protected]

0148036454

CHU de Rouen, Rouen, France

Status

Not yet recruiting

Address

CHU de Rouen

Rouen, , 76000

Site Contact

Emmanuel GERARDIN

[email protected]

0148036454

CHU de Strasbourg, Strasbourg, France

Status

Not yet recruiting

Address

CHU de Strasbourg

Strasbourg, , 67000

Site Contact

Seyyid BALOGLU

[email protected]

0148036454

CHU de Tours, Tours, France

Status

Not yet recruiting

Address

CHU de Tours

Tours, ,

Site Contact

Jean-Philippe COTTIER

[email protected]

0148036454