xml: <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/NCT06032390</url>
    </required_header>
    <id_info>
      <org_study_id>366405</org_study_id>
      <nct_id>NCT06032390</nct_id>
    </id_info>
    <brief_title>Artificial Intelligence in Mammography Screening in Norway</brief_title>
    <acronym>AIMS Norway</acronym>
    <official_title>Artificial Intelligence in BreastScreen Norway - a Randomized Controlled Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cancer Registry of Norway</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Helse Vest</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Helse Midt-Norge</agency>
        <agency_class>Other</agency_class>
      </collaborator>
      <collaborator>
        <agency>Helse Nord</agency>
        <agency_class>Industry</agency_class>
      </collaborator>
      <collaborator>
        <agency>Norwegian Cancer Society</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Cancer Registry of Norway</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The purpose of this randomized controlled trial is to compare the number of breast cancers&#xD;
        detected among women who had their screening mammograms interpreted by artificial&#xD;
        intelligence (AI) in combination with one or two breast radiologists to the number of breast&#xD;
        cancers detected after standard independent double reading in BreastScreen Norway. The aims&#xD;
        of the study is to prove that screening interpretation with AI in combination with one or two&#xD;
        radiologists (the intervention) is non-inferior to standard interpretation procedure.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Independent double reading with consensus is the recommended practice for breast cancer&#xD;
        screening programs in Europe. This is a time-consuming process and more than 99% of&#xD;
        examinations are determined to have a negative final outcome in BreastScreen Norway. However,&#xD;
        radiologist still overlook cancers, and review-studies have shown 20-25% of screen-detected&#xD;
        and interval cancers to be visible at prior screening mammograms. In Norway and other&#xD;
        countries, there is also a shortage of breast radiologists.&#xD;
  &#xD;
        Retrospective studies on AI in mammographic screening have shown promising results in the&#xD;
        classification of cancer negative and cancer positive examinations. However, prospective&#xD;
        studies are needed to elucidate questions concerning AI as a support or replacement for the&#xD;
        radiologists in the interpretation process.&#xD;
  &#xD;
        In this randomized controlled trial women attending screening and consenting to participate&#xD;
        in the study, will be randomized (1:1 allocation) to an intervention or a control group. The&#xD;
        screening examination will be performed as usual in both groups. The intervention in the&#xD;
        trial is the interpretation procedure.&#xD;
  &#xD;
        All examinations will be analyzed by AI. In the intervention group, examinations will be&#xD;
        triaged according to risk of malignancy defined by an AI score. Examinations with a low AI&#xD;
        score will have a single reading by one radiologist and examinations with a intermediate or&#xD;
        high AI score will have an independent double reading by two radiologists. All examinations&#xD;
        selected by either one or both radiologist will be discussed at consensus. Examinations with&#xD;
        an AI raw score of 9.8 or above will be discussed at consensus independent of the&#xD;
        radiologists' interpretation. The radiologists will be blinded to whether the mammograms are&#xD;
        interpreted by one or two radiologists. AI risk scores and AI image marking of suspicious&#xD;
        calcifications and masses are only provided to the radiologists at consensus, not during&#xD;
        independent reading. In the control group, two independent radiologists will interpret all&#xD;
        screening examinations according to standard procedure, independent double reading. AI&#xD;
        results will not be available at either independent reading or consensus, only for comparison&#xD;
        with the intervention group in final analyses.&#xD;
  &#xD;
        Screen-detected cancers in the intervention and control arm will be analyzed in terms of&#xD;
        non-inferiority.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">January 2024</start_date>
    <completion_date type="Anticipated">June 2033</completion_date>
    <primary_completion_date type="Anticipated">December 2026</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>
      <intervention_model_description>Participants will be randomized to an intervention or control arm. AI aided interpretation will be used in the intervention arm but not in the control arm.</intervention_model_description>
      <primary_purpose>Screening</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>Neither the participant nor the radiologic technician performing the mammography examination will know to what study arm the participant was allocated. Radiologists reading the screening examinations will be blinded to the intervention at initial reading but not at consensus.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Screen-detected breast cancers</measure>
      <time_frame>36 months from study start-up</time_frame>
      <description>Number of breast cancers detected at screening per 1000 screening examinations.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Consensus rate</measure>
      <time_frame>24 months from study start-up</time_frame>
      <description>Proportion of participant discussed in consensus among all participants (%).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Recall rate</measure>
      <time_frame>24 months from study start-up</time_frame>
      <description>Proportion of women recalled for further assessment among all participants (%).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Interval breast cancers</measure>
      <time_frame>60 months from study start-up</time_frame>
      <description>Number of interval breast cancers diagnosed per 1000 screening examinations.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prognostic and predictive tumor characteristics of screen-detected breast cancer</measure>
      <time_frame>36 months from study start-up</time_frame>
      <description>Distribution of tumor characteristics among the participants with screen-detected breast cancer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Prognostic and predictive tumor characteristics of interval breast cancer</measure>
      <time_frame>60 months from study start-up</time_frame>
      <description>Distribution of tumor characteristics among the participants with interval breast cancer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Sensitivity</measure>
      <time_frame>60 months from study start-up</time_frame>
      <description>Proportion of true positives among true positive and false negatives (%).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Specificity</measure>
      <time_frame>60 months from study start-up</time_frame>
      <description>Proportion of true negatives among true negatives and false positives (%).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mammographic features of screen-detected breast cancer</measure>
      <time_frame>36 months from study start-up</time_frame>
      <description>Distribution of characteristics of tumors observed on the mammograms of participants diagnosed with screen-detected breast cancer.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Time spent screen-reading</measure>
      <time_frame>36 months from study start-up</time_frame>
      <description>Time (minutes:seconds) spent by the individual radiologists interpreting screening mammograms</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">150000</enrollment>
    <condition>Breast Cancer</condition>
    <arm_group>
      <arm_group_label>Intervention arm</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>AI assisted mammography screening interpretation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control arm</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Standard mammography screening interpretation (standard procedure)</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>AI assisted mammography screening interpretation</intervention_name>
      <description>Screening examinations will be analyzed by the AI system (Transpara, ScreenPoint Medical, Nijmegen, The Netherlands) that assigns each examination a cancer risk score 1-10. Examinations with a score 1-7 will be single read and examinations with score 8-10 will be double read. Examinations selected by one or two readers will be discussed in consensus. Examinations with an AI score of 9.8 and above will be selected to consensus by default. Risk scores and AI image markings are provided to the readers only in consensus. The readers will decide whether to recall the woman for further assessment in consensus (standard procedure).</description>
      <arm_group_label>Intervention arm</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard mammography screening interpretation</intervention_name>
      <description>Screening examinations will be assessed according to standard of care: independently double read, examinations selected by one or two readers will be discussed in consensus, and the readers will decide whether to recall the woman for further assessment. Screening examinations will be analyzed by the AI system but the results will not be made available to the radiologist, only used for comparison to the intervention group in results analyses.</description>
      <arm_group_label>Control arm</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Women attending the population-based mammography screening program BreastScreen Norway&#xD;
               providing a signed, informed consent&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Women attending the population-based mammography screening program BreastScreen Norway&#xD;
               not providing a signed, informed consent, or with breast implants&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>50 Years</minimum_age>
      <maximum_age>69 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Solveig Hofvind, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cancer Registry of Norway</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Solveig Hofvind, PhD</last_name>
      <phone>22928828</phone>
      <phone_ext>+47</phone_ext>
      <email>sshh@kreftregisteret.no</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Åsne S Holen, MSc</last_name>
      <email>asho@kreftregisteret.no</email>
    </overall_contact_backup>
    <verification_date>June 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Breast Cancer Screening</keyword>
    <keyword>Digital Mammography</keyword>
    <keyword>Artificial Intelligence</keyword>
    <keyword>Randomized Controlled Trial</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>
      <ipd_description>Data will not be shared outside the project group.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06032390
  org study id: 366405
  nct id: NCT06032390
  lead sponsor: 
  collaborator: 
  collaborator: 
  collaborator: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  The purpose of this randomized controlled trial is to compare the number of breast cancers
        detected among women who had their screening mammograms interpreted by artificial
        intelligence (AI) in combination with one or two breast radiologists to the number of breast
        cancers detected after standard independent double reading in BreastScreen Norway. The aims
        of the study is to prove that screening interpretation with AI in combination with one or two
        radiologists (the intervention) is non-inferior to standard interpretation procedure.
  Independent double reading with consensus is the recommended practice for breast cancer
        screening programs in Europe. This is a time-consuming process and more than 99% of
        examinations are determined to have a negative final outcome in BreastScreen Norway. However,
        radiologist still overlook cancers, and review-studies have shown 20-25% of screen-detected
        and interval cancers to be visible at prior screening mammograms. In Norway and other
        countries, there is also a shortage of breast radiologists.
  
        Retrospective studies on AI in mammographic screening have shown promising results in the
        classification of cancer negative and cancer positive examinations. However, prospective
        studies are needed to elucidate questions concerning AI as a support or replacement for the
        radiologists in the interpretation process.
  
        In this randomized controlled trial women attending screening and consenting to participate
        in the study, will be randomized (1:1 allocation) to an intervention or a control group. The
        screening examination will be performed as usual in both groups. The intervention in the
        trial is the interpretation procedure.
  
        All examinations will be analyzed by AI. In the intervention group, examinations will be
        triaged according to risk of malignancy defined by an AI score. Examinations with a low AI
        score will have a single reading by one radiologist and examinations with a intermediate or
        high AI score will have an independent double reading by two radiologists. All examinations
        selected by either one or both radiologist will be discussed at consensus. Examinations with
        an AI raw score of 9.8 or above will be discussed at consensus independent of the
        radiologists' interpretation. The radiologists will be blinded to whether the mammograms are
        interpreted by one or two radiologists. AI risk scores and AI image marking of suspicious
        calcifications and masses are only provided to the radiologists at consensus, not during
        independent reading. In the control group, two independent radiologists will interpret all
        screening examinations according to standard procedure, independent double reading. AI
        results will not be available at either independent reading or consensus, only for comparison
        with the intervention group in final analyses.
  
        Screen-detected cancers in the intervention and control arm will be analyzed in terms of
        non-inferiority.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be randomized to an intervention or control arm. AI aided interpretation will be used in the intervention arm but not in the control arm.
  primary purpose: Screening
  masking: Double (Participant, Care Provider)
  masking description: Neither the participant nor the radiologic technician performing the mammography examination will know to what study arm the participant was allocated. Radiologists reading the screening examinations will be blinded to the intervention at initial reading but not at consensus.
  measure: Screen-detected breast cancers
  time frame: 36 months from study start-up
  description: Number of breast cancers detected at screening per 1000 screening examinations.
  measure: Consensus rate
  time frame: 24 months from study start-up
  description: Proportion of participant discussed in consensus among all participants (%).
  measure: Recall rate
  time frame: 24 months from study start-up
  description: Proportion of women recalled for further assessment among all participants (%).
  measure: Interval breast cancers
  time frame: 60 months from study start-up
  description: Number of interval breast cancers diagnosed per 1000 screening examinations.
  measure: Prognostic and predictive tumor characteristics of screen-detected breast cancer
  time frame: 36 months from study start-up
  description: Distribution of tumor characteristics among the participants with screen-detected breast cancer.
  measure: Prognostic and predictive tumor characteristics of interval breast cancer
  time frame: 60 months from study start-up
  description: Distribution of tumor characteristics among the participants with interval breast cancer.
  measure: Sensitivity
  time frame: 60 months from study start-up
  description: Proportion of true positives among true positive and false negatives (%).
  measure: Specificity
  time frame: 60 months from study start-up
  description: Proportion of true negatives among true negatives and false positives (%).
  measure: Mammographic features of screen-detected breast cancer
  time frame: 36 months from study start-up
  description: Distribution of characteristics of tumors observed on the mammograms of participants diagnosed with screen-detected breast cancer.
  measure: Time spent screen-reading
  time frame: 36 months from study start-up
  description: Time (minutes:seconds) spent by the individual radiologists interpreting screening mammograms
  arm group label: Intervention arm
  arm group type: Experimental
  description: AI assisted mammography screening interpretation
  arm group label: Control arm
  arm group type: Active Comparator
  description: Standard mammography screening interpretation (standard procedure)
  intervention type: Other
  intervention name: AI assisted mammography screening interpretation
  description: Screening examinations will be analyzed by the AI system (Transpara, ScreenPoint Medical, Nijmegen, The Netherlands) that assigns each examination a cancer risk score 1-10. Examinations with a score 1-7 will be single read and examinations with score 8-10 will be double read. Examinations selected by one or two readers will be discussed in consensus. Examinations with an AI score of 9.8 and above will be selected to consensus by default. Risk scores and AI image markings are provided to the readers only in consensus. The readers will decide whether to recall the woman for further assessment in consensus (standard procedure).
  arm group label: Intervention arm
  intervention type: Other
  intervention name: Standard mammography screening interpretation
  description: Screening examinations will be assessed according to standard of care: independently double read, examinations selected by one or two readers will be discussed in consensus, and the readers will decide whether to recall the woman for further assessment. Screening examinations will be analyzed by the AI system but the results will not be made available to the radiologist, only used for comparison to the intervention group in results analyses.
  arm group label: Control arm
  criteria: 
  gender: Female
  minimum age: 50 Years
  maximum age: 69 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Solveig Hofvind, PhD
  role: Principal Investigator
  affiliation: Cancer Registry of Norway
  last name: Solveig Hofvind, PhD
  phone: 22928828
  phone ext: +47
  email: sshh@kreftregisteret.no
  last name: Åsne S Holen, MSc
  email: asho@kreftregisteret.no
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No
  ipd description: Data will not be shared outside the project group.