<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03288792</url>
  </required_header>
  <id_info>
    <org_study_id>960-CSP-USA_DenseBreasts_USS1</org_study_id>
    <nct_id>NCT03288792</nct_id>
  </id_info>
  <brief_title>A Evaluation of 3D Functional MIRA System in Women With Mammographically Dense Breasts</brief_title>
  <official_title>A Prospective Multicenter Evaluation of Three Dimensional Functional Metabolic and Risk Assessment System in Women With Mammographically Dense Breasts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Real Imaging Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Real Imaging Ltd.</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system&#xD;
      used in conjunction with a conventional mammography to mammography alone, and to determine&#xD;
      whether the addition of supplementary RI8 result will improve ROC area under the curve. The&#xD;
      study is prospective, multi-center, sequential, control trial with the woman serving as her&#xD;
      own control. Women determined to have heterogeneously or extremely dense breast based on her&#xD;
      previous mammogram and are undergoing routine screening mammography at one of the clinical&#xD;
      sites assigned for this study will be eligible to join the study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Sponsor decision, not safety related&#xD;
  </why_stopped>
  <start_date type="Actual">April 15, 2018</start_date>
  <completion_date type="Actual">April 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 9, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in the area under the ROC curve when comparing mammography plus RI8 result to mammography alone.</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>All adverse events and serious adverse events caused by the imaging session as judged by the physician.</measure>
    <time_frame>18 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity will be computed based on the forced BI-RADS assessment of each mammography case alone and mammography plus RI8.</measure>
    <time_frame>18 months</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>Sensitivity and specificity of the device will be determined from all enrolled cases. Upper and lower estimates will be determined based on missing data.</measure>
    <time_frame>18 months</time_frame>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">435</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>RI8 device imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>RI8 Device imaging for adjunctive detection of breast cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>RI8 device imaging</intervention_name>
    <description>RI8 Device imaging for adjunctive detection of breast cancer</description>
    <arm_group_label>RI8 device imaging</arm_group_label>
    <other_name>Real Imager 8</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A. Subjects whose most recent (within 18 months) prior mammogram interpreted as&#xD;
        heterogeneously dense (ACR BI-RADS Breast Density C) or extremely dense (ACR BI-RADS Breast&#xD;
        Density D) breast tissue.&#xD;
&#xD;
        AND&#xD;
&#xD;
        B. Subjects who are asymptomatic and scheduled to undergo routine screening mammography.&#xD;
&#xD;
        OR&#xD;
&#xD;
        C. Subjects scheduled for image-guided needle biopsy as a result of findings obtained&#xD;
        during standard of care imaging modalities (mammography, ultrasound and/or MRI) performed&#xD;
        at the clinical site that participates in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Male by birth.&#xD;
&#xD;
          2. Individual is less than 40 and greater than 70 years old.&#xD;
&#xD;
          3. Contraindication to bilateral mammography or MRI.&#xD;
&#xD;
          4. Subjects who are unable to read, understand and execute the informed consent&#xD;
             procedure.&#xD;
&#xD;
          5. Subjects who have had mammography, ultrasound or MRI examination performed on the day&#xD;
             of the study prior to RI8 scan.&#xD;
&#xD;
          6. Subjects who are pre-menopausal and are between the 14th and 28th day after the start&#xD;
             of the menstrual cycle&#xD;
&#xD;
          7. Subjects who have significant existing breast trauma.&#xD;
&#xD;
          8. Subjects who have undergone lumpectomy/mastectomy.&#xD;
&#xD;
          9. Subjects who have undergone breast reduction or breast augmentation.&#xD;
&#xD;
         10. Subjects who have undergone any other type of breast surgery, including surgical&#xD;
             biopsy.&#xD;
&#xD;
         11. Subjects who have large breast scar / breast deformation&#xD;
&#xD;
         12. Subjects who have undergone a breast needle biopsy within the 6-week period prior to&#xD;
             their intended enrollment into the study.&#xD;
&#xD;
         13. Subjects who have a temperature &gt; 100° F (37.8C) degrees on the day of the RI8&#xD;
             imaging.&#xD;
&#xD;
         14. Subjects who are pregnant or lactating.&#xD;
&#xD;
         15. Subjects with known Raynaud's Disease.&#xD;
&#xD;
         16. Subjects with known Mastitis.&#xD;
&#xD;
         17. Subjects diagnosed with epileptic seizures.&#xD;
&#xD;
         18. Subjects with weight &gt; 135kg (~300 Lbs.).&#xD;
&#xD;
         19. Subjects who are claustrophobic or have physical limitations that do not allow them to&#xD;
             sit in the system chair for the required imaging session.&#xD;
&#xD;
         20. Subjects with implanted pacemaker/defibrillator, implanted venous access device&#xD;
             (portacath) or other implanted devices.&#xD;
&#xD;
         21. Subject with kidney failure&#xD;
&#xD;
         22. Subject with known allergy to gadolinium&#xD;
&#xD;
         23. Subject with a history of multiple contrast MRI scans (more than 4 MRI scans over the&#xD;
             past two year)&#xD;
&#xD;
         24. Inmates (45 CFR 46.306) or mentally disabled individuals.&#xD;
&#xD;
         25. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the&#xD;
             purpose of planning cancer therapy).&#xD;
&#xD;
         26. Subjects currently participating in another investigational clinical study.&#xD;
&#xD;
         27. Subject scheduled for a biopsy due to suspicious symptomatic lump&#xD;
&#xD;
         28. Subjects who participated in the Validation Phase will not be able to participate in&#xD;
             the Testing Phase&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Saddleback MemorialCare Breast Center</name>
      <address>
        <city>Laguna Hills</city>
        <state>California</state>
        <zip>92653</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Healthcare System</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Doris Shaheen Breast Health Center Piedmont Hospital</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30309</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Jackson Clinic</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38305</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://www.realimaging.com</url>
    <description>Sponsor's Web site</description>
  </link>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 20, 2017</study_first_posted>
  <last_update_submitted>May 1, 2019</last_update_submitted>
  <last_update_submitted_qc>May 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03288792
org study id: 960-CSP-USA_DenseBreasts_USS1
nct id: NCT03288792
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this image acquisition study is to compare, in a Reader Study, the RI8 system
      used in conjunction with a conventional mammography to mammography alone, and to determine
      whether the addition of supplementary RI8 result will improve ROC area under the curve. The
      study is prospective, multi-center, sequential, control trial with the woman serving as her
      own control. Women determined to have heterogeneously or extremely dense breast based on her
      previous mammogram and are undergoing routine screening mammography at one of the clinical
      sites assigned for this study will be eligible to join the study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Difference in the area under the ROC curve when comparing mammography plus RI8 result to mammography alone.
time frame: 18 months
measure: All adverse events and serious adverse events caused by the imaging session as judged by the physician.
time frame: 18 months
measure: Sensitivity and specificity will be computed based on the forced BI-RADS assessment of each mammography case alone and mammography plus RI8.
time frame: 18 months
measure: Sensitivity and specificity of the device will be determined from all enrolled cases. Upper and lower estimates will be determined based on missing data.
time frame: 18 months
arm group label: RI8 device imaging
arm group type: Experimental
description: RI8 Device imaging for adjunctive detection of breast cancer
intervention type: Device
intervention name: RI8 device imaging
description: RI8 Device imaging for adjunctive detection of breast cancer
arm group label: RI8 device imaging
other name: Real Imager 8
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
url: http://www.realimaging.com
description: Sponsor's Web site
responsible party type: Sponsor
sharing ipd: No