<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/NCT03271853</url>
  </required_header>
  <id_info>
    <org_study_id>SBS-001</org_study_id>
    <nct_id>NCT03271853</nct_id>
  </id_info>
  <brief_title>Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.</brief_title>
  <official_title>Thermalogical Analysis of a Cohort of Women and Men Undergoing Mammographic Analysis.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>First Sense Medical, LLC</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Toledo Health Science Campus</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>First Sense Medical, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data&#xD;
      by Therma-Scan.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      FirstSense Medical, LLC is a medical device company which has developed a breast cancer&#xD;
      screening device, the Sentinel BreastScan II [SBS II]. This radiation free device is being&#xD;
      developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. Dr.&#xD;
      Hoekstra, CEO of Therma-Scan, is the author of a published paper based on breast thermal data&#xD;
      with a reported 95% sensitivity and 91% specificity. The SBS II examination will take&#xD;
      approximately 7 minutes.&#xD;
&#xD;
      This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data&#xD;
      by Therma-Scan. SBS II thermal breast data is an adjunctive aid to standard breast imaging.&#xD;
      Currently, mammography is one of the standards of care in screening for visible signs of&#xD;
      breast cancer. Breast thermology is the analysis of the heat signature data from an examined&#xD;
      breast. All study costs will be incurred by the sponsor. Study subjects will incur no cost to&#xD;
      participate. All scientific data revealed in this protocol will be used for the specific&#xD;
      objectives of the study. The SBS II is a non-significant risk device. There is no contact&#xD;
      with the subject during the entire procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Suspended</overall_status>
  <why_stopped>
    Trial temporarily halted to conduct additional device testing to verify cooling data. This&#xD;
    temporary halt is NOT due to a potential risk to subject safety.&#xD;
  </why_stopped>
  <start_date type="Actual">November 3, 2017</start_date>
  <completion_date type="Anticipated">September 1, 2026</completion_date>
  <primary_completion_date type="Anticipated">September 1, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Measure protocol accuracy</measure>
    <time_frame>Through study completion, an average of 4 years.</time_frame>
    <description>To measure the sensitivity and specificity of thermographic analysis based on the Marseilles analytic protocol [ Th 1 thru 5 ] to biopsy results predicated on standard breast imaging criteria [ BIRADS analytical protocol, B1 thru B5 ]. The resultant BIRADS score and biopsy pathological results will be compared to thermographic analysis [ Th1 thru 5 ] for each subject. 50 subjects undergoing both thermography and standard breast imaging leading to biopsy [ BIRADS 3 thru 5 ] will then be compared by measuring the results of each, BIRADS for standard breast imaging v the Marseilles Th system used in thermographic analysis, for concordance or discordance of findings as measured on final pathological analysis. This analysis will be performed for each subsequent 50 patient cohort undergoing standard mammographic/ultrasound breast imaging analysis.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Breast Neoplasm Female</condition>
  <condition>Cancer, Breast</condition>
  <condition>Thermography</condition>
  <arm_group>
    <arm_group_label>SBS II</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Sentinel BreastScan II</intervention_name>
    <description>The SBS II will automate the recording of thermal data used in the Therma-Scan manual thermology protocol by utilizing a thermal camera sensitive to changes in breast temperature. The SBS II system uses a very sensitive thermography camera that detects and visually displays heat patterns that naturally emanate from the breast. SBS II captures this data digitally for subsequent analysis by Therma-Scan.</description>
    <arm_group_label>SBS II</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study population consists of any patient undergoing standard mammographic examination&#xD;
        and/or any additional imaging study predicated on the results of mammography.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or Female, over the age of 18 years of age.&#xD;
&#xD;
          -  Asymptomatic women or women who are being screened for breast abnormality.&#xD;
&#xD;
          -  Women scheduled for a mammogram or women who have had a mammogram and are given 3 days&#xD;
             to wait in between their mammogram and scheduled biopsy and FS/TS system.&#xD;
&#xD;
          -  Not pregnant or breast feeding.&#xD;
&#xD;
          -  Signed Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject does not meet inclusion criteria, noted above.&#xD;
&#xD;
          -  Use of 100 mg or more of niacin by tablet or niacin patch within the last 24 hours.&#xD;
&#xD;
          -  Use of nitroglycerin within the last 24 hours.&#xD;
&#xD;
          -  Subject experienced a fever of 102°F or higher within thirty-six (36) hours of the&#xD;
             study.&#xD;
&#xD;
          -  Subject must not have had a mammogram, breast ultrasound, or breast exam within the&#xD;
             last 72 hours prior to the SBS II.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Male or Female, over the age of 18 years.</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Haitham Elsamaloty</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Toledo</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eleanor N. Dana Cancer Center, University of Toledo</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>July 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 5, 2017</study_first_posted>
  <last_update_submitted>January 8, 2018</last_update_submitted>
  <last_update_submitted_qc>January 8, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 10, 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>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 28, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03271853/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>June 16, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/53/NCT03271853/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03271853
org study id: SBS-001
nct id: NCT03271853
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data
      by Therma-Scan.
FirstSense Medical, LLC is a medical device company which has developed a breast cancer
      screening device, the Sentinel BreastScan II [SBS II]. This radiation free device is being
      developed to produce data which will be analyzed by Therma-Scan Reference Laboratory. Dr.
      Hoekstra, CEO of Therma-Scan, is the author of a published paper based on breast thermal data
      with a reported 95% sensitivity and 91% specificity. The SBS II examination will take
      approximately 7 minutes.

      This study is designed to evaluate the Sentinel BreastScan II as well as the analysis of data
      by Therma-Scan. SBS II thermal breast data is an adjunctive aid to standard breast imaging.
      Currently, mammography is one of the standards of care in screening for visible signs of
      breast cancer. Breast thermology is the analysis of the heat signature data from an examined
      breast. All study costs will be incurred by the sponsor. Study subjects will incur no cost to
      participate. All scientific data revealed in this protocol will be used for the specific
      objectives of the study. The SBS II is a non-significant risk device. There is no contact
      with the subject during the entire procedure.
observational model: Cohort
time perspective: Prospective
measure: Measure protocol accuracy
time frame: Through study completion, an average of 4 years.
description: To measure the sensitivity and specificity of thermographic analysis based on the Marseilles analytic protocol [ Th 1 thru 5 ] to biopsy results predicated on standard breast imaging criteria [ BIRADS analytical protocol, B1 thru B5 ]. The resultant BIRADS score and biopsy pathological results will be compared to thermographic analysis [ Th1 thru 5 ] for each subject. 50 subjects undergoing both thermography and standard breast imaging leading to biopsy [ BIRADS 3 thru 5 ] will then be compared by measuring the results of each, BIRADS for standard breast imaging v the Marseilles Th system used in thermographic analysis, for concordance or discordance of findings as measured on final pathological analysis. This analysis will be performed for each subsequent 50 patient cohort undergoing standard mammographic/ultrasound breast imaging analysis.
arm group label: SBS II
intervention type: Device
intervention name: Sentinel BreastScan II
description: The SBS II will automate the recording of thermal data used in the Therma-Scan manual thermology protocol by utilizing a thermal camera sensitive to changes in breast temperature. The SBS II system uses a very sensitive thermography camera that detects and visually displays heat patterns that naturally emanate from the breast. SBS II captures this data digitally for subsequent analysis by Therma-Scan.
arm group label: SBS II
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
gender based: Yes
gender description: Male or Female, over the age of 18 years.
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Haitham Elsamaloty
role: Principal Investigator
affiliation: University of Toledo
facility: 
country: United States
responsible party type: Sponsor
mesh term: Breast Neoplasms
provided document: 
provided document: 