<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/NCT03791853</url>
  </required_header>
  <id_info>
    <org_study_id>LightCT-PKUPH</org_study_id>
    <nct_id>NCT03791853</nct_id>
  </id_info>
  <brief_title>Light-CT in the Diagnosis of Breast Tumor and Lymph Node</brief_title>
  <official_title>Achieving Rapid Diagnosis During Breast Cancer Surgery Using Light-CT (High-resolution Full-field Optical Coherence Tomography and Dynamic Cell Imaging)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University People's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University People's Hospital</source>
  <oversight_info>
    <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>
      Intraoperative pathological diagnosis such as frozen section and imprint cytology is not&#xD;
      routinely recommended in clinical practice because of time and accuracy concerns. Full-field&#xD;
      optical coherence tomography (FF-OCT) is a new optical imaging technique that could generate&#xD;
      sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the&#xD;
      morphological structure and pathological changes in minutes without conventional tissue&#xD;
      preparation, slicing, and staining, and dynamic cell imaging (DCI) added the viability&#xD;
      information of cells/tissue, which could be more important in cancer diagnosis. This study&#xD;
      was to evaluate the feasibility and diagnostic value of FF-OCT and DCI in breast lesions and&#xD;
      lymph node specimens during breast cancer surgery. We evaluated normal breast tissue, benign&#xD;
      breast lesions, breast cancer and axillary lymph node specimens resected from patients&#xD;
      undergoing breast surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Light-CT, a special-designed pathology-approximation system which is based on the lighting&#xD;
      feature or dynamic feature of tissue and cells, is used to detect malignant cells or tissue&#xD;
      in fresh specimens. Morphological structure and pathological changes could be captured in&#xD;
      minutes, which implies a possible application in intraoperative diagnosis. In this study,&#xD;
      fresh breast tissue, fat, benign breast lesions, breast cancer and axillary lymph node&#xD;
      specimens are collected to assess the usefulness of Light-CT. During the in vitro&#xD;
      examination, both FF-OCT and DCI images are obtained and stored. Imaging analysis would be&#xD;
      performed in traditional imaging analysis like manner and an artificial intelligence aided&#xD;
      approach as well.&#xD;
&#xD;
      In this study, breast and lymph node specimens would be collected and imaged both through&#xD;
      light imaging and conventional pathological analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">December 12, 2022</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>Sensitivity of Light-CT</measure>
    <time_frame>One week after the release of the pathological reports.</time_frame>
    <description>The true positive rate measures the proportion of positives that are correctly identified by ultrasound</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The lighting feature of different tissue</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>By the comparison analysis of FF-OCT and DCI images and corresponding pathological images, lighting feature would be extracted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of Light-CT</measure>
    <time_frame>One week after the release of the pathological reports.</time_frame>
    <description>The true negative rate measures the proportion of positives that are correctly identified by Light-CT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Examination time</measure>
    <time_frame>Through study completion, an average of 1 year</time_frame>
    <description>The time from the specimen preparation to the completion of the examination.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Breast Neoplasms</condition>
  <arm_group>
    <arm_group_label>Light-CT</arm_group_label>
    <description>All specimens are detected using Light-CT</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Light-CT</intervention_name>
    <description>Fresh specimen is trimmed into a block with a size not larger than 2.5 cm (Typically not larger than 1.5 cm). Prepared specimen is submitted to Light-CT tests. FF-OCT images are obtained to depict the structure information and DCI images are generated to collect the dynamic information of the cell and tissue. After the imaging detection, specimens are submitted for routine pathological diagnosis to obtain corresponding pathological images.</description>
    <arm_group_label>Light-CT</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients planning to undergoing breast surgery and breast cancer patient planning to&#xD;
        undergoing surgical lymph node staging are eligible for this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients planning to undergoing breast surgery/surgical lymph node staging.&#xD;
&#xD;
          -  Specimen could be obtained.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Prior open biopsy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>shu wang, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking University People's Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Houpu Yang, M.D.</last_name>
    <phone>+86-10-88324010</phone>
    <email>yanghoupu@pkuph.edu.cn</email>
  </overall_contact>
  <location>
    <facility>
      <name>Breast Center, Peking University People's Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100044</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Houpu Yang, M.D.</last_name>
      <phone>8610-88324010</phone>
      <email>yanghoupu@pkuph.edu.cn</email>
    </contact>
    <investigator>
      <last_name>Shu Wang, M.D.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Chaoyang Hospital</name>
      <address>
        <city>Beijing</city>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>He Liu, MD</last_name>
    </contact>
    <investigator>
      <last_name>Hongchuan Jiang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Xuanwu Hospital of Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <zip>100000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kaifu Li, MD</last_name>
    </contact>
    <investigator>
      <last_name>Hua Kang, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 31, 2018</study_first_submitted>
  <study_first_submitted_qc>December 31, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">January 3, 2019</study_first_posted>
  <last_update_submitted>December 5, 2021</last_update_submitted>
  <last_update_submitted_qc>December 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Breast Neoplasms</keyword>
  <keyword>Optical Coherence Tomogram</keyword>
  <keyword>Sentinel lymph node</keyword>
  <keyword>Dynamic cell imaging</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>Undecided</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/NCT03791853
org study id: LightCT-PKUPH
nct id: NCT03791853
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Intraoperative pathological diagnosis such as frozen section and imprint cytology is not
      routinely recommended in clinical practice because of time and accuracy concerns. Full-field
      optical coherence tomography (FF-OCT) is a new optical imaging technique that could generate
      sectioning tomogram from fresh tissue and provide close-to-pathology depiction of the
      morphological structure and pathological changes in minutes without conventional tissue
      preparation, slicing, and staining, and dynamic cell imaging (DCI) added the viability
      information of cells/tissue, which could be more important in cancer diagnosis. This study
      was to evaluate the feasibility and diagnostic value of FF-OCT and DCI in breast lesions and
      lymph node specimens during breast cancer surgery. We evaluated normal breast tissue, benign
      breast lesions, breast cancer and axillary lymph node specimens resected from patients
      undergoing breast surgery.
Light-CT, a special-designed pathology-approximation system which is based on the lighting
      feature or dynamic feature of tissue and cells, is used to detect malignant cells or tissue
      in fresh specimens. Morphological structure and pathological changes could be captured in
      minutes, which implies a possible application in intraoperative diagnosis. In this study,
      fresh breast tissue, fat, benign breast lesions, breast cancer and axillary lymph node
      specimens are collected to assess the usefulness of Light-CT. During the in vitro
      examination, both FF-OCT and DCI images are obtained and stored. Imaging analysis would be
      performed in traditional imaging analysis like manner and an artificial intelligence aided
      approach as well.

      In this study, breast and lymph node specimens would be collected and imaged both through
      light imaging and conventional pathological analysis.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity of Light-CT
time frame: One week after the release of the pathological reports.
description: The true positive rate measures the proportion of positives that are correctly identified by ultrasound
measure: The lighting feature of different tissue
time frame: Through study completion, an average of 1 year
description: By the comparison analysis of FF-OCT and DCI images and corresponding pathological images, lighting feature would be extracted.
measure: Specificity of Light-CT
time frame: One week after the release of the pathological reports.
description: The true negative rate measures the proportion of positives that are correctly identified by Light-CT.
measure: Examination time
time frame: Through study completion, an average of 1 year
description: The time from the specimen preparation to the completion of the examination.
arm group label: Light-CT
description: All specimens are detected using Light-CT
intervention type: Diagnostic Test
intervention name: Light-CT
description: Fresh specimen is trimmed into a block with a size not larger than 2.5 cm (Typically not larger than 1.5 cm). Prepared specimen is submitted to Light-CT tests. FF-OCT images are obtained to depict the structure information and DCI images are generated to collect the dynamic information of the cell and tissue. After the imaging detection, specimens are submitted for routine pathological diagnosis to obtain corresponding pathological images.
arm group label: Light-CT
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: shu wang, M.D.
role: Principal Investigator
affiliation: Peking University People's Hospital
last name: Houpu Yang, M.D.
phone: +86-10-88324010
email: yanghoupu@pkuph.edu.cn
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: Undecided