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/NCT05989022</url>
    </required_header>
    <id_info>
      <org_study_id>ldBCT-MRI-C</org_study_id>
      <nct_id>NCT05989022</nct_id>
    </id_info>
    <brief_title>Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics</brief_title>
    <official_title>Comparison of Low-dose Spiral Breast CT With MRI in Major Indications of MRI for Breast Diagnostics</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>AB-CT - Advanced Breast-CT GmbH</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>CRO Dr. med. Kottmann GmbH</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>AB-CT - Advanced Breast-CT GmbH</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Comparison between two diagnostic modalities for breast cancer diagnosis. Two different&#xD;
        imaging systems are compared to evaluate the performance of the two systems&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The diagnostic quality of MRI of the breast has made this method a gold standard in the&#xD;
        imaging of senologic lesions. Low-dose dedicated breast CT (BCT) with single photon-detection&#xD;
        (nu:view, developed by AB-CT - Advanced Breast-CT GmbH) has emerged as a fully 3D imaging&#xD;
        modality that uses ionizing radiation comparable to 2D mammography and has its intended use&#xD;
        in helping with diagnosis in diagnostic breast imaging.&#xD;
  &#xD;
        The investigation is designed as a prospective non-randomized intra-individual cohort&#xD;
        procedure comparison between the imaging platforms, nu:view and MRI. Across 3 hospital-based&#xD;
        study sites in two countries, study participants (patients who meet study criteria and have&#xD;
        consented) sequentially receive nu:view imaging and, with a delay of up to one week&#xD;
        (preferably on the same day), MRI imaging. At both times, patients receive contrast agent.&#xD;
        Images generated from breasts are evaluated by three independent radiologists and their&#xD;
        scores and interpretations are statistically evaluated. The research aim is to demonstrate&#xD;
        non-inferiority of BCT compared with MRI in major indications of MRI for breast diagnostics.&#xD;
  &#xD;
        The perceived gain in the study is to generate data on clinical performance of the BCT device&#xD;
        nu:view and on the procedure that could be supportive of a tailored use of nu:view in&#xD;
        patients with major indications of MRI for breast diagnostics.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">December 2024</completion_date>
    <primary_completion_date type="Anticipated">August 2024</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>
      <intervention_model_description>Comparison between both modalities in single patients</intervention_model_description>
      <primary_purpose>Diagnostic</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis</measure>
      <time_frame>one year</time_frame>
      <description>The primary objective is to demonstrate non-inferiority of CE-BCT with CE-MRI in the BI-RADS detection at the lesion level in the diagnosis of eight indications for CE-MRI diagnosis.&#xD;
  Patients with with major indications of CE-MRI will receive an additional diagnosis with CE-BCT. The images of both modalities will be compared by 3 independent raters which were randomly assigned to pseudonymized images. That rating follow the six BI-RADS Scales on lesion basis. The descriptive data will be compared according the evaluated BI-RADS scores of the raters and both modalities. For the non-inferiority test, the mean difference of lesion-wise BI-RADS scores between modalities will be used; it is expected that the mean BI-RADS values at lesion level are almost equal for both modalities.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Collect data for comfort of CE-BCT and CE-MRI</measure>
      <time_frame>one year</time_frame>
      <description>The secondary objective is to collect data for comfort of CE-BCT and CE-MRI using a patient questionnaire of closed questions. The questionnaire asks in 7 categories for 1. Overall rating of the examination 2. Comfort of the device during examination 3. The feel of the operating noise of the device 4. The rating of the space provided by the device 5. The duration of the examination 6. The question if the patient would agree to have the examination again, if necessary with the device 7. After both modalities which diagnostic method would be the preference, MRI or BCT. Every question can be rated with 5 possible ratings from very good to very bad or adapted possibilities like pleasantly quit to unpleasantly loud.</description>
    </secondary_outcome>
    <number_of_arms>1</number_of_arms>
    <enrollment type="Anticipated">428</enrollment>
    <condition>Breast Cancer Diagnosis</condition>
    <arm_group>
      <arm_group_label>Imaging Breast Diagnostic</arm_group_label>
      <arm_group_type>Other</arm_group_type>
      <description>Imaging breast diagnostic where patients receive both modalities MRI and B-CT to compare the resolution of the two different diagnostic devices in the same patient</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Injection of contrast enhancing agent Gadovist for MRI investigation</intervention_name>
      <description>Image enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis</description>
      <arm_group_label>Imaging Breast Diagnostic</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Injection of contrast enhancing agent Imeron for B-CT investigation</intervention_name>
      <description>Image enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis</description>
      <arm_group_label>Imaging Breast Diagnostic</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Sex: female&#xD;
  &#xD;
            2. Age: at least 18 years&#xD;
  &#xD;
            3. Inconclusive findings in conventional imaging or preoperative staging or evaluation of&#xD;
               therapy response in the neoadjuvant chemotherapy setting or imaging of the breast&#xD;
               after breast-conserving therapy or finding the cause of hemorrhagic nipple discharge&#xD;
               or prosthesis imaging or screening of women with hereditary or familial increased risk&#xD;
               for the development of breast cancer or axillary lymph node metastasis suspected to&#xD;
               originate from breast tissue&#xD;
  &#xD;
            4. Persons able and willing to understand and sign informed consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Known pregnancy or breastfeeding&#xD;
  &#xD;
            2. Presence of BRCA1 or BRCA2 allele&#xD;
  &#xD;
            3. Insufficient renal function (MDRD)&#xD;
  &#xD;
            4. Dysfunction of the thyroid gland (TSH degradation)&#xD;
  &#xD;
            5. Known allergy or intolerance against iodine-containing contrast enhancing agents or&#xD;
               MRI contrast enhancing agents&#xD;
  &#xD;
            6. Patients with paramagnetic or magnetic material inside the breast, claustrophobia&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <gender_based>Yes</gender_based>
      <gender_description>Only women</gender_description>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Radiologisches Institut Universitätsklinikum Erlangen</name>
        <address>
          <city>Erlangen</city>
          <zip>91054</zip>
          <country>Germany</country>
        </address>
      </facility>
      <contact>
        <last_name>Sabine Ohlmeyer, Dr. med</last_name>
        <phone>+49 9131 85</phone>
        <phone_ext>33460</phone_ext>
        <email>Radiologie@uk-erlangen.de</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Stichting Martini Ziekenhuis</name>
        <address>
          <city>Groningen</city>
          <zip>9728 NT</zip>
          <country>Netherlands</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Leiden University Medical Centre</name>
        <address>
          <city>Leiden</city>
          <zip>2333 ZA</zip>
          <country>Netherlands</country>
        </address>
      </facility>
      <contact>
        <last_name>Martin Wasser, MD</last_name>
        <phone>+31 71 526</phone>
        <phone_ext>1840</phone_ext>
        <email>radiologieafsprakenCT-MRI@lumc.nl</email>
      </contact>
    </location>
    <location_countries>
      <country>Germany</country>
      <country>Netherlands</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 2, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Breast CT</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>
  
  
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/NCT05989022
  org study id: ldBCT-MRI-C
  nct id: NCT05989022
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Comparison between two diagnostic modalities for breast cancer diagnosis. Two different
        imaging systems are compared to evaluate the performance of the two systems
  The diagnostic quality of MRI of the breast has made this method a gold standard in the
        imaging of senologic lesions. Low-dose dedicated breast CT (BCT) with single photon-detection
        (nu:view, developed by AB-CT - Advanced Breast-CT GmbH) has emerged as a fully 3D imaging
        modality that uses ionizing radiation comparable to 2D mammography and has its intended use
        in helping with diagnosis in diagnostic breast imaging.
  
        The investigation is designed as a prospective non-randomized intra-individual cohort
        procedure comparison between the imaging platforms, nu:view and MRI. Across 3 hospital-based
        study sites in two countries, study participants (patients who meet study criteria and have
        consented) sequentially receive nu:view imaging and, with a delay of up to one week
        (preferably on the same day), MRI imaging. At both times, patients receive contrast agent.
        Images generated from breasts are evaluated by three independent radiologists and their
        scores and interpretations are statistically evaluated. The research aim is to demonstrate
        non-inferiority of BCT compared with MRI in major indications of MRI for breast diagnostics.
  
        The perceived gain in the study is to generate data on clinical performance of the BCT device
        nu:view and on the procedure that could be supportive of a tailored use of nu:view in
        patients with major indications of MRI for breast diagnostics.
  allocation: N/A
  intervention model: Single Group Assignment
  intervention model description: Comparison between both modalities in single patients
  primary purpose: Diagnostic
  masking: None (Open Label)
  measure: Non-inferiority of CE-BCT compared with CE-MRI in Breast Cancer diagnosis
  time frame: one year
  description: The primary objective is to demonstrate non-inferiority of CE-BCT with CE-MRI in the BI-RADS detection at the lesion level in the diagnosis of eight indications for CE-MRI diagnosis.
  Patients with with major indications of CE-MRI will receive an additional diagnosis with CE-BCT. The images of both modalities will be compared by 3 independent raters which were randomly assigned to pseudonymized images. That rating follow the six BI-RADS Scales on lesion basis. The descriptive data will be compared according the evaluated BI-RADS scores of the raters and both modalities. For the non-inferiority test, the mean difference of lesion-wise BI-RADS scores between modalities will be used; it is expected that the mean BI-RADS values at lesion level are almost equal for both modalities.
  measure: Collect data for comfort of CE-BCT and CE-MRI
  time frame: one year
  description: The secondary objective is to collect data for comfort of CE-BCT and CE-MRI using a patient questionnaire of closed questions. The questionnaire asks in 7 categories for 1. Overall rating of the examination 2. Comfort of the device during examination 3. The feel of the operating noise of the device 4. The rating of the space provided by the device 5. The duration of the examination 6. The question if the patient would agree to have the examination again, if necessary with the device 7. After both modalities which diagnostic method would be the preference, MRI or BCT. Every question can be rated with 5 possible ratings from very good to very bad or adapted possibilities like pleasantly quit to unpleasantly loud.
  arm group label: Imaging Breast Diagnostic
  arm group type: Other
  description: Imaging breast diagnostic where patients receive both modalities MRI and B-CT to compare the resolution of the two different diagnostic devices in the same patient
  intervention type: Diagnostic Test
  intervention name: Injection of contrast enhancing agent Gadovist for MRI investigation
  description: Image enhancing contrast agent will be injected to enhance MRI resolution in breast cancer diagnosis
  arm group label: Imaging Breast Diagnostic
  intervention type: Diagnostic Test
  intervention name: Injection of contrast enhancing agent Imeron for B-CT investigation
  description: Image enhancing contrast agent will be injected to enhance B-CT resolution in breast cancer diagnosis
  arm group label: Imaging Breast Diagnostic
  criteria: 
  gender: Female
  gender based: Yes
  gender description: Only women
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  contact: 
  facility: 
  facility: 
  contact: 
  country: Germany
  country: Netherlands
  responsible party type: Sponsor
  mesh term: Breast Neoplasms
  sharing ipd: No