<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/NCT02210546</url>
  </required_header>
  <id_info>
    <org_study_id>RF-2009-1539582</org_study_id>
    <nct_id>NCT02210546</nct_id>
  </id_info>
  <brief_title>Contrast-enhanced MR Imaging as a Breast Cancer Screening in Women at Intermediate Risk</brief_title>
  <acronym>MRIB</acronym>
  <official_title>A Multicenter Randomised Trial of Contrast-enhanced MR Imaging as a Breast Cancer Screening Tool Alternative to Mammography and Ultrasonography in Women at Intermediate Risk. Feasibility, and Short Term Results.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Prof. Paolo Bruzzi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicenter randomized controlled trial to evaluate the performance of MRI, in terms of&#xD;
      sensitivity, specificity, and predictive value, in the screening of women at intermediate&#xD;
      risk of breast cancer.&#xD;
&#xD;
      Two surveillance programs will be compared. Women will be randomly assigned with a 1:1 ratio&#xD;
      to:&#xD;
&#xD;
        1. Yearly two-view mammography (Mx) and breast ultrasonography (US) or&#xD;
&#xD;
        2. Yearly MRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Women, who, due to an increased risk of invasive breast cancer, are offered a specific&#xD;
      surveillance program, as a supplement to the standard screening activities which in Italy are&#xD;
      based on mammography every two years starting at age 50.Women will be randomly assigned to&#xD;
      Yearly two-view mammography (Mx) and breast ultrasonography (US) or to Yearly MRI.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2013</start_date>
  <completion_date type="Anticipated">September 2016</completion_date>
  <primary_completion_date type="Anticipated">May 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Screening</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Rate of in situ and invasive breast cancers detected in the two arms of the study</measure>
    <time_frame>36 months</time_frame>
    <description>The performance of MRI will be evaluated , in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of patients per each clinical and pathological stage of invasive cancer detected in the two arms of the study</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of the different histological characteristics of cancers detected in the two arms</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of invasive diagnostic procedures in the two study arms.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of interval cancers in the two study arms.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of eligible women who accept to enter the study.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compliance to the intervention in the two study arms.</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms</measure>
    <time_frame>3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of cancers (in situ and invasive) detected in excess in the experimental arm compared to the conventional arm (overdiagnosis) after 10 years of follow up</measure>
    <time_frame>10 years</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Magnetic Resonance Imaging (MRI)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo MRI yearly</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mammography (Mx) + ultrasonography (US)</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Patients will undergo yearly two-view (Mx) and breast US</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Magnetic Resonance Imaging (MRI)</intervention_name>
    <arm_group_label>Magnetic Resonance Imaging (MRI)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Mammography (Mx) + ultrasonography (US)</intervention_name>
    <arm_group_label>Mammography (Mx) + ultrasonography (US)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women aged 40-59 years with&#xD;
&#xD;
          -  cumulative risk at 10 years of at least 5%, or a lifetime cumulative breast cancer&#xD;
             risk ranging between 15% and 30% (equivalent to a relative risk of 2-6 as compared to&#xD;
             a low risk woman of the same age). The lifetime cumulative risk of breast cancer will&#xD;
             be computed using the IBIS Breast Cancer Risk Evaluation Tool&#xD;
             (http://www.ems-trials.org/riskevaluator/); or mammographic density involving more&#xD;
             than 75% of the breast area, based on the most recent mammogram. The evaluation of the&#xD;
             composition of the mammary gland will be performed using the BI-RADS classification.&#xD;
             Women with mammography in class 4 (i.e., &gt;75% of glandular component) will be eligible&#xD;
             for randomization.&#xD;
&#xD;
          -  Written Informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Signs or symptoms of breast cancer at enrolment;&#xD;
&#xD;
          -  Previous diagnosis of ductal carcinoma in situ or invasive breast cancer;&#xD;
&#xD;
          -  BRCA or p53 mutation carrier status;&#xD;
&#xD;
          -  General contraindications to MRI (e.g. cardiac pacemaker, metal implants or history of&#xD;
             severe allergic reaction after administration of contrast agent;&#xD;
&#xD;
          -  Contraindications to any intravenous administration of contrast agent;&#xD;
&#xD;
          -  Ongoing or planned pregnancy (for the duration of the study);&#xD;
&#xD;
          -  Hormonal enhancement of ovarian function for assisted reproduction in the previous 3&#xD;
             years&#xD;
&#xD;
          -  Presence of breast implants;&#xD;
&#xD;
          -  Previous diagnosis of cancer at any site;&#xD;
&#xD;
          -  Life-threatening diseases;&#xD;
&#xD;
          -  Mental disability precluding informed consent to participate&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Antonella Petrillo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Paolo Belli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Policlinico Gemelli (Rome)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alessandro Del Maschio, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ospedale san Raffaele (Milan)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Laura Martincich, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS Candiolo (Turin)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Massimo Bazzocchi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AOU S.Maria della Misericordia (Udine)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Piero Panizza, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Istituto Nazionale dei Tumori (Milan)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stefania Montemezzi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliera Universitaria Integrata Verona</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Federica Pediconi, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Policlinico Umberto I (Rome)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Stefano Corcione, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Azienda Ospedaliero Universitaria (Ferrara)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Massimo Calabrese, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS AOU S. Martino-IST (Genoa)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Francesco Sardanelli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>IRCCS San Donato (Milan)</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Paolo Bruzzi, MD</last_name>
    <phone>+390105558476</phone>
    <email>paolo.bruzzi@hsanmartino.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>IRCCS Azienda Ospedaliera Universitaria S.Martino IST</name>
      <address>
        <city>Genova</city>
        <zip>16132</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Paolo Bruzzi, MD</last_name>
      <phone>+390105558476</phone>
      <email>paolo.bruzzi@hsanmartino.it</email>
    </contact>
    <investigator>
      <last_name>Paolo Bruzzi, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>May 27, 2013</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>August 4, 2014</last_update_submitted>
  <last_update_submitted_qc>August 4, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 6, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy</investigator_affiliation>
    <investigator_full_name>Prof. Paolo Bruzzi</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>breast cancer</keyword>
  <keyword>intermediate risk</keyword>
  <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/NCT02210546
org study id: RF-2009-1539582
nct id: NCT02210546
lead sponsor: 
has dmc: No
A multicenter randomized controlled trial to evaluate the performance of MRI, in terms of
      sensitivity, specificity, and predictive value, in the screening of women at intermediate
      risk of breast cancer.

      Two surveillance programs will be compared. Women will be randomly assigned with a 1:1 ratio
      to:

        1. Yearly two-view mammography (Mx) and breast ultrasonography (US) or

        2. Yearly MRI.
Women, who, due to an increased risk of invasive breast cancer, are offered a specific
      surveillance program, as a supplement to the standard screening activities which in Italy are
      based on mammography every two years starting at age 50.Women will be randomly assigned to
      Yearly two-view mammography (Mx) and breast ultrasonography (US) or to Yearly MRI.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Screening
masking: None (Open Label)
measure: Rate of in situ and invasive breast cancers detected in the two arms of the study
time frame: 36 months
description: The performance of MRI will be evaluated , in terms of sensitivity, specificity, and predictive value, in the screening of women at intermediate risk of breast cancer
measure: Number of patients per each clinical and pathological stage of invasive cancer detected in the two arms of the study
time frame: 3 years
measure: Proportion of the different histological characteristics of cancers detected in the two arms
time frame: 3 years
measure: Number of invasive diagnostic procedures in the two study arms.
time frame: 3 years
measure: Number of interval cancers in the two study arms.
time frame: 3 years
measure: Rate of eligible women who accept to enter the study.
time frame: 3 years
measure: Compliance to the intervention in the two study arms.
time frame: 3 years
measure: Average and interquartile range of the risk profiles computed according to IBIS Breast Cancer Risk Evaluation Tool in the two arms
time frame: 3 years
measure: Number of cancers (in situ and invasive) detected in excess in the experimental arm compared to the conventional arm (overdiagnosis) after 10 years of follow up
time frame: 10 years
arm group label: Magnetic Resonance Imaging (MRI)
arm group type: Experimental
description: Patients will undergo MRI yearly
arm group label: Mammography (Mx) + ultrasonography (US)
arm group type: Other
description: Patients will undergo yearly two-view (Mx) and breast US
intervention type: Other
intervention name: Magnetic Resonance Imaging (MRI)
arm group label: Magnetic Resonance Imaging (MRI)
intervention type: Other
intervention name: Mammography (Mx) + ultrasonography (US)
arm group label: Mammography (Mx) + ultrasonography (US)
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 59 Years
healthy volunteers: No
last name: Antonella Petrillo, MD
role: Principal Investigator
affiliation: Istituto Nazionale dei Tumori IRCCS Fondazione Pascale (Naples)
last name: Paolo Belli, MD
role: Principal Investigator
affiliation: Policlinico Gemelli (Rome)
last name: Alessandro Del Maschio, MD
role: Principal Investigator
affiliation: Ospedale san Raffaele (Milan)
last name: Laura Martincich, MD
role: Principal Investigator
affiliation: IRCCS Candiolo (Turin)
last name: Massimo Bazzocchi, MD
role: Principal Investigator
affiliation: AOU S.Maria della Misericordia (Udine)
last name: Piero Panizza, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Istituto Nazionale dei Tumori (Milan)
last name: Stefania Montemezzi, MD
role: Principal Investigator
affiliation: Azienda Ospedaliera Universitaria Integrata Verona
last name: Federica Pediconi, MD
role: Principal Investigator
affiliation: Azienda Policlinico Umberto I (Rome)
last name: Stefano Corcione, MD
role: Principal Investigator
affiliation: Azienda Ospedaliero Universitaria (Ferrara)
last name: Massimo Calabrese, MD
role: Principal Investigator
affiliation: IRCCS AOU S. Martino-IST (Genoa)
last name: Francesco Sardanelli, MD
role: Principal Investigator
affiliation: IRCCS San Donato (Milan)
last name: Paolo Bruzzi, MD
phone: +390105558476
email: paolo.bruzzi@hsanmartino.it
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Sponsor-Investigator
investigator affiliation: IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
investigator full name: Prof. Paolo Bruzzi
investigator title: MD
mesh term: Breast Neoplasms