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

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ClinicalTrials.gov Identifier: NCT04113395
Recruitment Status : Recruiting
First Posted : October 2, 2019
Last Update Posted : February 7, 2020
Sponsor:
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 ]


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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
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

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 ClinicalTrials.gov identifier (NCT number): NCT04113395


Contacts
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Contact: Amelie YAVCHITZ, PhD 0148036454 ayavchitz@for.paris
Contact: Augustin Lecler 0418036401 alecler@for.paris

Locations
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France
Fondation ophtalmique Adolphe de Rothschild Recruiting
Paris, France, 75019
Contact: Augustin Lecler, MD       alecler@fo-rothschild.fr   
Sponsors and Collaborators
Fondation Ophtalmologique Adolphe de Rothschild

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Responsible Party: Fondation Ophtalmologique Adolphe de Rothschild
ClinicalTrials.gov Identifier: NCT04113395    
Other Study ID Numbers: ALR_2019_14
First Posted: October 2, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020
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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Meningioma
Neoplasms, Nerve Tissue
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Vascular Tissue
Meningeal Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Nervous System Diseases