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Clinical trials for BI-RADS

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44364   clinical trials with a EudraCT protocol, of which   7388   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
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    8 result(s) found for: BI-RADS. Displaying page 1 of 1.
    EudraCT Number: 2020-004828-42 Sponsor Protocol Number: ATOS-016R Start Date*: 2021-08-30
    Sponsor Name:Atossa Therapeutics Inc.
    Full Title: A Phase 2, Randomized, Double-blinded, Placebo - controlled, Dose Response Study of Oral (Z)-endoxifen in Premenopausal Women with Measurable Breast Density
    Medical condition: The mammographic density reduction in healthy women
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: SE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002906-10 Sponsor Protocol Number: BHR-700-301 Start Date*: 2018-08-16
    Sponsor Name:BHR Pharma, LLC
    Full Title: A Randomized, Double-blind, Placebo Controlled Trial of 4-Hydroxytamoxifen Gel for Reducing Breast Tissue Density in Women with BI-RADS Breast Density Categories C or D
    Medical condition: Breast tissue density in women with BI-RADS Breast Density Categories C to D
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004848 10065307 Breast density increased LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: DE (Completed) ES (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-005498-21 Sponsor Protocol Number: Start Date*: 2012-07-12
    Sponsor Name:Med. Univ. Wien, Univ. Klinik für Radiodiagnostik
    Full Title: Breast lesion detection and characterization at contrast-Enhanced MRI of the breast: comparison of gadoterate meglumine versus gadobenate dimeglumine at 3 Tesla
    Medical condition: the aim of this study is to intraindividually compare the use of equivalent doses of gadobenate dimeglumine (MultiHance, Bracco Imaging, Milan, Italy) and gadoterate meglumine (DOTAREM, Guerbet, Fr...
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000573-72 Sponsor Protocol Number: ATOS-010 Start Date*: 2018-04-21
    Sponsor Name:Atossa Genetics Inc
    Full Title: Karma CREME-1: A double-blind, placebo-controlled, three-armed, pilot study of the effects, safety and tolerability of topical endoxifen in women within the Karma Cohort
    Medical condition: The mammographic density reduction in healthy women.
    Disease:
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2006-004613-18 Sponsor Protocol Number: MH-131 Start Date*: 2007-06-04
    Sponsor Name:BRACCO IMAGING
    Full Title: Phase III, Multicenter, Double-blind, Randomized, Crossover Study to Compare MultiHancE with MagnevisT in Contrast-Enhanced MagnetiC Resonance Imaging MRI of the BreasT. - DETECT -
    Medical condition: patiens with breast lesions which are highly suspicious or already known for malignancy which are requested for MRI
    Disease: Version SOC Term Classification Code Term Level
    6.1 10006279 PT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: IT (Completed) DE (Completed) GB (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2009-009597-27 Sponsor Protocol Number: BAY86-4875/91743 Start Date*: Information not available in EudraCT
    Sponsor Name:Bayer Health Care AG (study performed by Bayer Schering Pharma AG)
    Full Title: An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1...
    Medical condition: Patients with histologically confirmed breast cancer referred to MRM prior to surgery after XRM.
    Disease: Version SOC Term Classification Code Term Level
    12.0 10012992 Digital mammography LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) FI (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2009-009598-90 Sponsor Protocol Number: 91782 Start Date*: 2010-08-20
    Sponsor Name:Bayer Health Care AG (study performed by Bayer Schering Pharma AG)
    Full Title: An open label, multi-center, phase 3 study with corresponding blinded image reading to determine the efficacy and safety of a single intravenous injection of 0.1 mmol/kg body weight of gadobutrol 1...
    Medical condition: Patients with histologically confirmed breast cancer referred to MRM prior to surgery after XRM.
    Disease: Version SOC Term Classification Code Term Level
    12.1 10012992 Digital mammography LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) DE (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2017-003089-29 Sponsor Protocol Number: 69918356615 Start Date*: 2018-04-06
    Sponsor Name:Medical University of Vienna, Department of Biomedical Imaging and Image-guided Therapy
    Full Title: Measuring hallmarks of cancer for non-invasive characterization of breast lesions by simultaneous multiparametric 18F-ethylcholine PET- MRI – an exploratory study
    Medical condition: Patients with imaging suspected breast cancer (BI-RADS 4&5 on conventional imaging, e.g. mammography and ultrasound).
    Disease: Version SOC Term Classification Code Term Level
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006291 Breast neoplasms malignant and unspecified (incl nipple) HLGT
    20.0 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) 10006288 Breast neoplasms benign (incl nipple) HLGT
    20.0 10022891 - Investigations 10029815 Nuclear magnetic resonance imaging PT
    20.0 10022891 - Investigations 10036223 Positron emission tomography LLT
    Population Age: Adults, Elderly Gender: Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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