<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/NCT03296683</url>
  </required_header>
  <id_info>
    <org_study_id>960-CLP-ITL_RI8 _ITS1</org_study_id>
    <nct_id>NCT03296683</nct_id>
  </id_info>
  <brief_title>Evaluation of a 3D Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer</brief_title>
  <official_title>Evaluation of a Three Dimensional Functional Metabolic Imaging and Risk Assessment System in Classifying Women for Likelihood of Breast Cancer</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>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study objective is to evaluate the added value of MIRA technology as an adjunct to&#xD;
      mammography in the detection of malignant breast lesions in women with dense breast and/or at&#xD;
      elevated risk of breast cancer.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 23, 2017</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 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>Increase in incremental cancer detection rate</measure>
    <time_frame>24 months</time_frame>
    <description>Statistically significant increase of 30% or more in incremental cancer detection rate</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">1200</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>MIRA device imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MIRA Device imaging for adjunctive detection of breast cancer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>MIRA device imaging</intervention_name>
    <description>MIRA Device imaging for adjunctive detection of breast cancer</description>
    <arm_group_label>MIRA device imaging</arm_group_label>
    <other_name>Real Imager 8</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        **Calibration Phase:&#xD;
&#xD;
        A.Subjects who are asymptomatic and scheduled to undergo routine screening mammography.&#xD;
&#xD;
        OR&#xD;
&#xD;
        B.Subjects scheduled for image guided needle biopsy as a result of findings obtained during&#xD;
        standard of care (mammography, ultrasound and/or MRI)&#xD;
&#xD;
        **Testing Phase:&#xD;
&#xD;
        A. Subjects scheduled to undergo routine screening mammography and at least one of the&#xD;
        following :&#xD;
&#xD;
          -  Subjects whose most recent (within 3 years) prior mammogram was interpreted as&#xD;
             heterogeneously dense (ACR BI-RADS Breast Density 3) or extremely dense (ACR BI-RADS&#xD;
             Breast Density 4).&#xD;
&#xD;
          -  Subjects whose current 10-year IBIS breast cancer risk is 5% or higher.&#xD;
&#xD;
        EXCLUSION CRITERIA, valid for both calibration and testing phases:&#xD;
&#xD;
          1. Male by birth.&#xD;
&#xD;
          2. Individual is less than 24 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 MIRA scan.&#xD;
&#xD;
          6. Subjects who have significant existing breast trauma.&#xD;
&#xD;
          7. Subjects who have undergone lumpectomy/mastectomy.&#xD;
&#xD;
          8. Subjects who have undergone breast reduction or breast augmentation.&#xD;
&#xD;
          9. Subjects who have undergone any other type of breast surgery.&#xD;
&#xD;
         10. Subjects who have large breast scar / Breast deformation.&#xD;
&#xD;
         11. Subjects who have undergone a breast needle biopsy within the 6 month period prior to&#xD;
             their intended enrollment into the study.&#xD;
&#xD;
         12. Subjects who have a temperature &gt; 100° F (37.8C) degrees on the day of the MIRA&#xD;
             imaging.&#xD;
&#xD;
         13. Subjects who are pregnant or lactating.&#xD;
&#xD;
         14. Subjects who have had placement of an internal breast marker.&#xD;
&#xD;
         15. Subjects with known Raynaud's Disease.&#xD;
&#xD;
         16. Subjects that are claustrophobic or have physical limitations that do allow them to&#xD;
             sit in the system chair for the required imaging session.&#xD;
&#xD;
         17. Subjects with implanted pacemaker/defibrillator, implanted venous access device&#xD;
             (portacath) or other implanted devices.&#xD;
&#xD;
         18. Subjects with a BI-RADS category 6 (e.g. for which mammogram was performed for the&#xD;
             purpose of planning cancer therapy).&#xD;
&#xD;
         19. Subjects affected with epilepsy.&#xD;
&#xD;
         20. Subjects who participated in the Calibration Phase will not be able to participate in&#xD;
             the Testing Phase.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>24 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Francesco Sardanelli, M.D</last_name>
    <role>Principal Investigator</role>
    <affiliation>Policlinico San Donato</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>David Izhaky</last_name>
    <phone>+972-3-972-0602</phone>
    <email>david@realimaging.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Policlinico San Donato</name>
      <address>
        <city>San Donato Milanese</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francesco Sardanelli, M.D.</last_name>
      <phone>39-02-52774468</phone>
      <email>f.sardanelli@grupposandonato.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>June 2018</verification_date>
  <study_first_submitted>September 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>June 17, 2018</last_update_submitted>
  <last_update_submitted_qc>June 17, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">June 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <!-- 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/NCT03296683
org study id: 960-CLP-ITL_RI8 _ITS1
nct id: NCT03296683
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The study objective is to evaluate the added value of MIRA technology as an adjunct to
      mammography in the detection of malignant breast lesions in women with dense breast and/or at
      elevated risk of breast cancer.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Increase in incremental cancer detection rate
time frame: 24 months
description: Statistically significant increase of 30% or more in incremental cancer detection rate
arm group label: MIRA device imaging
arm group type: Experimental
description: MIRA Device imaging for adjunctive detection of breast cancer
intervention type: Device
intervention name: MIRA device imaging
description: MIRA Device imaging for adjunctive detection of breast cancer
arm group label: MIRA device imaging
other name: Real Imager 8
criteria: 
gender: Female
minimum age: 24 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Francesco Sardanelli, M.D
role: Principal Investigator
affiliation: Policlinico San Donato
last name: David Izhaky
phone: +972-3-972-0602
email: david@realimaging.com
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
mesh term: Breast Neoplasms