<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/NCT01723124</url>
  </required_header>
  <id_info>
    <org_study_id>12-004322</org_study_id>
    <nct_id>NCT01723124</nct_id>
  </id_info>
  <brief_title>Low-dose Molecular Breast Imaging: Comparison of Breast Cancer Detection Rate at Initial Screening and Two-year Follow-up</brief_title>
  <official_title>Comparison of Breast Cancer Detection Rate for Prevalent Screen Low-dose Molecular Breast Imaging and Incident Biennial Screen Low-dose Molecular Breast Imaging in Women With Mammographically Dense Breasts</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this research is to evaluate whether repeating a screening Molecular Breast&#xD;
      Imaging (MBI) study two years after an initial screening MBI study further improves breast&#xD;
      cancer detection in women with dense breast tissue.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Dose specified in protocol was not adequate to achieve optimal resolution.&#xD;
  </why_stopped>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2014</completion_date>
  <primary_completion_date type="Actual">May 2014</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>Diagnostic</primary_purpose>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Molecular Breast Imaging (MBI) scan</measure>
    <time_frame>Performed at Year 0 of study</time_frame>
    <description>The Year 0 MBI will be interpreted in isolation, with the radiologist blinded to Year 0 mammogram results and all relevant clinical information.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Molecular Breast Imaging (MBI) scan</measure>
    <time_frame>Performed at Year 2 of study</time_frame>
    <description>The Year 2 MBI will be interpreted in comparison with the Year 0 MBI but in isolation from the Year 2 mammogram.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Comparison of breast cancer detection rate for Year 0 and Year 2.</measure>
    <time_frame>Year 2 of study</time_frame>
    <description>The breast cancer detection rate for Year 0 and Year 2 MBI will be compared to each other and to the breast cancer detection rates for the screening mammograms performed in Year 0 and Year 2.</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">228</enrollment>
  <condition>Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Molecular Breast Imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Molecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Molecular Breast Imaging</intervention_name>
    <description>Molecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors.</description>
    <arm_group_label>Molecular Breast Imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        - Past prior screening mammogram within the previous 11-24 months interpreted as&#xD;
        heterogeneously dense or extremely dense and negative or benign [Breast Imaging Reporting&#xD;
        and Data System (BI-RADS) Category 1 or 2]&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Subjects will be excluded if they:&#xD;
&#xD;
          -  Are unable to understand and sign the consent form&#xD;
&#xD;
          -  Are pregnant or lactating&#xD;
&#xD;
          -  Are physically unable to sit upright and still for 40 minutes&#xD;
&#xD;
          -  Have self-reported signs or symptoms that may suggest breast cancer (palpable mass,&#xD;
             bloody nipple discharge, axillary mass, etc.)&#xD;
&#xD;
          -  Have had needle biopsy within 3 months, or breast surgery or radiation within 1 year&#xD;
             prior to the study&#xD;
&#xD;
          -  Are currently receiving chemotherapy or tamoxifen, raloxifene, or an aromatase&#xD;
             inhibitor for adjuvant therapy or chemoprevention&#xD;
&#xD;
          -  Have undergone bilateral mastectomy&#xD;
&#xD;
          -  Have had a prior MBI within 20 months of scheduled study MBI.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deborah Rhodes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>http://newsblog.mayoclinic.org/2008/09/03/breast-cancer-molecular-breast-imaging-mammography/</url>
    <description>Mayo Clinic News</description>
  </link>
  <link>
    <url>http://www.youtube.com/watch?v=DOQBLe8MdH0</url>
    <description>Mayo Clinic You Tube Channel</description>
  </link>
  <reference>
    <citation>Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2.</citation>
    <PMID>21045179</PMID>
  </reference>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>July 24, 2012</study_first_submitted>
  <study_first_submitted_qc>November 5, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 7, 2012</study_first_posted>
  <last_update_submitted>September 19, 2016</last_update_submitted>
  <last_update_submitted_qc>September 19, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Deborah Rhodes</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>Dense breast tissue</keyword>
  <keyword>breast cancer screening</keyword>
  <keyword>molecular breast imaging</keyword>
  <keyword>breast cancer</keyword>
  <keyword>breast</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <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/NCT01723124
org study id: 12-004322
nct id: NCT01723124
lead sponsor: 
has dmc: No
The purpose of this research is to evaluate whether repeating a screening Molecular Breast
      Imaging (MBI) study two years after an initial screening MBI study further improves breast
      cancer detection in women with dense breast tissue.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Single (Investigator)
measure: Molecular Breast Imaging (MBI) scan
time frame: Performed at Year 0 of study
description: The Year 0 MBI will be interpreted in isolation, with the radiologist blinded to Year 0 mammogram results and all relevant clinical information.
measure: Molecular Breast Imaging (MBI) scan
time frame: Performed at Year 2 of study
description: The Year 2 MBI will be interpreted in comparison with the Year 0 MBI but in isolation from the Year 2 mammogram.
measure: Comparison of breast cancer detection rate for Year 0 and Year 2.
time frame: Year 2 of study
description: The breast cancer detection rate for Year 0 and Year 2 MBI will be compared to each other and to the breast cancer detection rates for the screening mammograms performed in Year 0 and Year 2.
arm group label: Molecular Breast Imaging
arm group type: Experimental
description: Molecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors.
intervention type: Procedure
intervention name: Molecular Breast Imaging
description: Molecular Breast Imaging (MBI) utilizes small high resolution gamma camera detectors in a dual-detector configuration to image the breast following the administration of a radiopharmaceutical that accumulates preferentially in breast tumors.
arm group label: Molecular Breast Imaging
criteria: 
gender: Female
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Deborah Rhodes, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: http://newsblog.mayoclinic.org/2008/09/03/breast-cancer-molecular-breast-imaging-mammography/
description: Mayo Clinic News
url: http://www.youtube.com/watch?v=DOQBLe8MdH0
description: Mayo Clinic You Tube Channel
citation: Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2.
PMID: 21045179
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Deborah Rhodes
investigator title: MD
mesh term: Breast Neoplasms
sharing ipd: No