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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04113395
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : September 17, 2021
Information provided by (Responsible Party):
Fondation Ophtalmologique Adolphe de Rothschild

Brief 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. 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.

Condition or disease Intervention/treatment
Meningioma Other: sequences T1 FE

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Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Concordance and Accuracy of Magnetic Resonance Imaging in the Detection of Meningiomas: Optimizing Sequences With Low Doses of Gadolinium
Actual Study Start Date : December 23, 2019
Estimated Primary Completion Date : December 23, 2022
Estimated Study Completion Date : December 23, 2022

Resource links provided by the National Library of Medicine

Intervention Details:
  • Other: sequences T1 FE
    T1 TSE and T1 TFE sequences with a duration of 6 minutes are added to the imaging protocol.
    Other Name: T1 TFE sequences

Primary Outcome Measures :
  1. Evaluate the diagnostic concordance in terms of meningioma detection between the 3T MRI sequences with a Gadolinium injection reduced to 1/6th and the full dose sequences (Gold Standard). [ Time Frame: 1 day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients presenting to the radiology department of the Adolphe de Rothschild Foundation for an MRI, as part of a screening or monitoring of meningioma

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT04113395

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Contact: Amelie YAVCHITZ, PhD 0148036454
Contact: Augustin Lecler 0418036401

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CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33076
Contact: Patrice MENEGON   
Principal Investigator: Patrice MENEGON         
CHU de Grenoble Not yet recruiting
Grenoble, France, 38100
Contact: Sylvie Grand   
Principal Investigator: Sylvie Grand         
CHU de Limoges Recruiting
Limoges, France, 87042
Contact: Aymeric ROUCHAUD   
Principal Investigator: Aymeric ROUCHAUD         
CHU de Lyon Recruiting
Lyon, France, 69495
Contact: François Cotton   
Principal Investigator: François Cotton         
CHU de Nantes Recruiting
Nantes, France, 44800
Contact: Jesus GARCIA   
Principal Investigator: Jesus GARCIA         
Fondation ophtalmique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Augustin Lecler, MD   
CHU de Rennes Not yet recruiting
Rennes, France, 35033
Contact: Béatrice CARSIN-NICOL   
Principal Investigator: Béatrice CARSIN-NICOL         
CHU de Rouen Not yet recruiting
Rouen, France, 76000
Contact: Emmanuel GERARDIN   
Principal Investigator: Emmanuel GERARDIN         
CHU de Strasbourg Not yet recruiting
Strasbourg, France, 67000
Contact: Seyyid BALOGLU   
Principal Investigator: Seyyid BALOGLU         
CHU de Tours Not yet recruiting
Tours, France
Contact: Jean-Philippe COTTIER   
Principal Investigator: Jean-Philippe COTTIER         
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild
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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild Identifier: NCT04113395    
Other Study ID Numbers: ALR_2019_14
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: September 17, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases