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/NCT05994898</url>
    </required_header>
    <id_info>
      <org_study_id>UHFUSGGO01</org_study_id>
      <nct_id>NCT05994898</nct_id>
    </id_info>
    <brief_title>Ultrahigh-frequency Ultrasonography (UHFUS) in Detection of Small Pulmonary Ground Glass Opacity (GGO)</brief_title>
    <acronym>UHFUSGGO</acronym>
    <official_title>The Value of Ultrahigh-frequency Ultrasonography (UHFUS) in Detection of Small Pulmonary Ground Glass Opacity (GGO) in Vitro: A Prospective Pilot Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking Union Medical College Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking Union Medical College Hospital</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>
        The purpose of this study is to assess the feasibility of UHFUS on detection of GGOs in&#xD;
        excised lung tissue and investigate UHFUS features of GGO in vitro.&#xD;
  &#xD;
        Each GGO was detected by palpation, UHFUS and open biopsy in sequence. The comparison of&#xD;
        detection rate and time consumption were analyzed respectively. The Bland-Altman analysis was&#xD;
        used to estimate the agreement of tumor size measured by CT, UHFUS and pathology.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Lung cancer (LC) is a leading cause of mortality worldwide. According to the International&#xD;
        Agency for Research (IARC) on Cancer, LC was projected to contribute to 2.3 million new&#xD;
        cancer cases and 1.8 million deaths worldwide in 2020. With widespread use of chest computed&#xD;
        tomography (CT), LC is increasingly detected at an early stage, in which 63%-95% lesions&#xD;
        present as ground glass opacity (GGO).&#xD;
  &#xD;
        GGO refers to a non-specific radiological appearance, referring to a focal, hazy shadow with&#xD;
        increased attenuation that does not obscure the contours of bronchi or blood vessels on CT.&#xD;
        It can be benign lesions, preinvasive, or invasive adenocarcinoma. Surgery is the main&#xD;
        treatment for suspected malignant GGOs. Whether excised targeted GGOs thoroughly affects&#xD;
        patients' prognosis crucially, especially for patients with multiple GGOs. Generally, the&#xD;
        most frequent intraoperative location approach of pulmonary nodules is palpation, which&#xD;
        distinguished by the texture between normal lung tissue and nodules. However, different from&#xD;
        solid nodules, the texture of GGO nodules is similar to lung parenchyma that increases the&#xD;
        difficulty of palpation localization. Thus, detection of GGOs and in lung tissue poses a&#xD;
        common challenge, particularly in the presence of pure GGO (tumor without an solid component)&#xD;
        and small GGO nodules (≤1cm).&#xD;
  &#xD;
        In the current clinical practice, even with preoperative localization (CT-guided percutaneous&#xD;
        and intraoperative electromagnetic navigation bronchoscopy), it remains challenging to&#xD;
        confirm complete resection of all small, pure GGOs. Therefore, there is an urgent need for a&#xD;
        new method that can accurately evaluate nodules in excised lung tissue. Since Roberto used&#xD;
        thoracoscopic ultrasound (TUS) to examine pulmonary nodules in 1999, subsequently, several&#xD;
        studies have validated the safety and efficacy for using US in identifying pulmonary nodules&#xD;
        intraoperatively. However, past research all focused on solid nodules or large nodules&#xD;
        (maximum diameter more than 2cm) using 5-12MHz US transducer. Few studies have studied the&#xD;
        detection rate of small GGO nodules.&#xD;
  &#xD;
        Previous studies have found 12MHz of US probe could show pulmonary nodules better than 5MHz&#xD;
        and 7.5MHz. Ultrahigh frequency ultrasound (UHFUS) refers to higher frequency (≥20MHz)&#xD;
        ultrasound waves with higher resolution even less than 50μm. It is capable to display nodules&#xD;
        less than 3mm distinctively in the extremely superficial tissue, which may satisfy&#xD;
        intraoperative GGO imaging requirement. Therefore, the objects of this study are to assess&#xD;
        the feasibility of localizing GGOs in excised lung tissue by UHFUS and further summarize its&#xD;
        UHFUS features.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">January 4, 2023</start_date>
    <completion_date type="Anticipated">September 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">August 30, 2023</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>Detection rate</measure>
      <time_frame>From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)</time_frame>
      <description>Detection rate of UHFUS and palpation methods</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Detection time</measure>
      <time_frame>From enrollment to the end of surgery</time_frame>
      <description>Detection time of UHFUS and palpation methods</description>
    </secondary_outcome>
    <other_outcome>
      <measure>UHFUS imaging features</measure>
      <time_frame>From enrollment to the end of surgery</time_frame>
      <description>UHFUS imaging features of GGOs</description>
    </other_outcome>
    <other_outcome>
      <measure>Tumor size</measure>
      <time_frame>From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)</time_frame>
      <description>The agreement of tumor size measured by CT, UHFUS and pathology</description>
    </other_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Lung Nodules</condition>
    <condition>Ultrasound</condition>
    <condition>Detection Rate</condition>
    <arm_group>
      <arm_group_label>UHFUS</arm_group_label>
      <description>Pulmonary nodules were detected by UHFUS method.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Palpation</arm_group_label>
      <description>Pulmonary nodules were detected by palpation method.</description>
    </arm_group>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with targeted GGOs and will accept VATS or RATS resection&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Patients with targeted nodules identified as lesions required surgical removed such as&#xD;
               main lesion and high-risk nodules;&#xD;
  &#xD;
            2. Patients who accept VATS or RATS resection.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Patients refused enrollment in the trial;&#xD;
  &#xD;
            2. Pulmonary nodules were labelled during the operation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Shanqing Li, Prof.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking Union Medical College Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Xuehan Gao, MD</last_name>
      <phone>+86 18801341299</phone>
      <email>gaoxh1299@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Yuanjing Gao, MD</last_name>
      <phone>+86 16619765781</phone>
      <email>610066214@qq.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Department of thoracic surgery</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100730</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Xuahan Gao, MD</last_name>
        <phone>+86 18801341299</phone>
        <email>gaoxh1299@163.com</email>
      </contact>
      <contact_backup>
        <last_name>Yuanjing Gao, MD</last_name>
        <phone>+86 16619765781</phone>
        <email>610066214@qq.com</email>
      </contact_backup>
      <investigator>
        <last_name>Xuehan Gao, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Ujiie H, Kato T, Hu HP, Hasan S, Patel P, Wada H, Lee D, Fujino K, Hwang DM, Cypel M, de Perrot M, Pierre A, Darling G, Waddell TK, Keshavjee S, Yasufuku K. Evaluation of a New Ultrasound Thoracoscope for Localization of Lung Nodules in Ex Vivo Human Lungs. Ann Thorac Surg. 2017 Mar;103(3):926-934. doi: 10.1016/j.athoracsur.2016.08.031. Epub 2016 Oct 17.</citation>
      <PMID>27765176</PMID>
    </reference>
    <reference>
      <citation>Yamamoto M, Takeo M, Meguro F, Ishikawa T. Sonographic evaluation for peripheral pulmonary nodules during video-assisted thoracoscopic surgery. Surg Endosc. 2003 May;17(5):825-7. doi: 10.1007/s00464-002-8900-0. Epub 2003 Jan 18.</citation>
      <PMID>12584601</PMID>
    </reference>
    <reference>
      <citation>Sortini D, Feo CV, Carcoforo P, Carrella G, Pozza E, Liboni A, Sortini A. Thoracoscopic localization techniques for patients with solitary pulmonary nodule and history of malignancy. Ann Thorac Surg. 2005 Jan;79(1):258-62; discussion 262. doi: 10.1016/j.athoracsur.2004.06.012.</citation>
      <PMID>15620953</PMID>
    </reference>
    <reference>
      <citation>Wada H, Anayama T, Hirohashi K, Nakajima T, Kato T, Waddell TK, Keshavjee S, Yoshino I, Yasufuku K. Thoracoscopic ultrasonography for localization of subcentimetre lung nodules. Eur J Cardiothorac Surg. 2016 Feb;49(2):690-7. doi: 10.1093/ejcts/ezv124. Epub 2015 Apr 7.</citation>
      <PMID>25855597</PMID>
    </reference>
    <reference>
      <citation>Santambrogio R, Montorsi M, Bianchi P, Mantovani A, Ghelma F, Mezzetti M. Intraoperative ultrasound during thoracoscopic procedures for solitary pulmonary nodules. Ann Thorac Surg. 1999 Jul;68(1):218-22. doi: 10.1016/s0003-4975(99)00459-2.</citation>
      <PMID>10421144</PMID>
    </reference>
    <reference>
      <citation>Matsunaga T, Suzuki K, Takamochi K, Oh S. What is the radiological definition of part-solid tumour in lung cancer?dagger. Eur J Cardiothorac Surg. 2017 Feb 1;51(2):242-247. doi: 10.1093/ejcts/ezw344.</citation>
      <PMID>28119328</PMID>
    </reference>
    <reference>
      <citation>Hou YL, Wang YD, Guo HQ, Zhang Y, Guo Y, Han H. Ultrasound location of pulmonary nodules in video-assisted thoracoscopic surgery for precise sublobectomy. Thorac Cancer. 2020 May;11(5):1354-1360. doi: 10.1111/1759-7714.13384. Epub 2020 Mar 17.</citation>
      <PMID>32180358</PMID>
    </reference>
    <reference>
      <citation>Zhang Y, Fu F, Chen H. Management of Ground-Glass Opacities in the Lung Cancer Spectrum. Ann Thorac Surg. 2020 Dec;110(6):1796-1804. doi: 10.1016/j.athoracsur.2020.04.094. Epub 2020 Jun 7.</citation>
      <PMID>32525031</PMID>
    </reference>
    <reference>
      <citation>Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.</citation>
      <PMID>33538338</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 16, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 16, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
      <investigator_full_name>Xuehan Gao</investigator_full_name>
      <investigator_title>MD</investigator_title>
    </responsible_party>
    <keyword>lung nodules</keyword>
    <keyword>ground glass opacity</keyword>
    <keyword>Ultrahigh frequency ultrasound</keyword>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>Study protocol, SAP, and ICF could be shared.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_time_frame>6 months after the trial finnshed.</ipd_time_frame>
      <ipd_access_criteria>Contact investigators by email (GXH: gaoxh1299@163.com, GYJ: 610066214@qq.com).</ipd_access_criteria>
    </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/NCT05994898
  org study id: UHFUSGGO01
  nct id: NCT05994898
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The purpose of this study is to assess the feasibility of UHFUS on detection of GGOs in
        excised lung tissue and investigate UHFUS features of GGO in vitro.
  
        Each GGO was detected by palpation, UHFUS and open biopsy in sequence. The comparison of
        detection rate and time consumption were analyzed respectively. The Bland-Altman analysis was
        used to estimate the agreement of tumor size measured by CT, UHFUS and pathology.
  Lung cancer (LC) is a leading cause of mortality worldwide. According to the International
        Agency for Research (IARC) on Cancer, LC was projected to contribute to 2.3 million new
        cancer cases and 1.8 million deaths worldwide in 2020. With widespread use of chest computed
        tomography (CT), LC is increasingly detected at an early stage, in which 63%-95% lesions
        present as ground glass opacity (GGO).
  
        GGO refers to a non-specific radiological appearance, referring to a focal, hazy shadow with
        increased attenuation that does not obscure the contours of bronchi or blood vessels on CT.
        It can be benign lesions, preinvasive, or invasive adenocarcinoma. Surgery is the main
        treatment for suspected malignant GGOs. Whether excised targeted GGOs thoroughly affects
        patients' prognosis crucially, especially for patients with multiple GGOs. Generally, the
        most frequent intraoperative location approach of pulmonary nodules is palpation, which
        distinguished by the texture between normal lung tissue and nodules. However, different from
        solid nodules, the texture of GGO nodules is similar to lung parenchyma that increases the
        difficulty of palpation localization. Thus, detection of GGOs and in lung tissue poses a
        common challenge, particularly in the presence of pure GGO (tumor without an solid component)
        and small GGO nodules (≤1cm).
  
        In the current clinical practice, even with preoperative localization (CT-guided percutaneous
        and intraoperative electromagnetic navigation bronchoscopy), it remains challenging to
        confirm complete resection of all small, pure GGOs. Therefore, there is an urgent need for a
        new method that can accurately evaluate nodules in excised lung tissue. Since Roberto used
        thoracoscopic ultrasound (TUS) to examine pulmonary nodules in 1999, subsequently, several
        studies have validated the safety and efficacy for using US in identifying pulmonary nodules
        intraoperatively. However, past research all focused on solid nodules or large nodules
        (maximum diameter more than 2cm) using 5-12MHz US transducer. Few studies have studied the
        detection rate of small GGO nodules.
  
        Previous studies have found 12MHz of US probe could show pulmonary nodules better than 5MHz
        and 7.5MHz. Ultrahigh frequency ultrasound (UHFUS) refers to higher frequency (≥20MHz)
        ultrasound waves with higher resolution even less than 50μm. It is capable to display nodules
        less than 3mm distinctively in the extremely superficial tissue, which may satisfy
        intraoperative GGO imaging requirement. Therefore, the objects of this study are to assess
        the feasibility of localizing GGOs in excised lung tissue by UHFUS and further summarize its
        UHFUS features.
  observational model: Cohort
  time perspective: Prospective
  measure: Detection rate
  time frame: From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)
  description: Detection rate of UHFUS and palpation methods
  measure: Detection time
  time frame: From enrollment to the end of surgery
  description: Detection time of UHFUS and palpation methods
  measure: UHFUS imaging features
  time frame: From enrollment to the end of surgery
  description: UHFUS imaging features of GGOs
  measure: Tumor size
  time frame: From enrollment to the pathology of GGOs were confirmed (4 weeks after sugery)
  description: The agreement of tumor size measured by CT, UHFUS and pathology
  arm group label: UHFUS
  description: Pulmonary nodules were detected by UHFUS method.
  arm group label: Palpation
  description: Pulmonary nodules were detected by palpation method.
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Shanqing Li, Prof.
  role: Principal Investigator
  affiliation: Peking Union Medical College Hospital
  last name: Xuehan Gao, MD
  phone: +86 18801341299
  email: gaoxh1299@163.com
  last name: Yuanjing Gao, MD
  phone: +86 16619765781
  email: 610066214@qq.com
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: China
  citation: Ujiie H, Kato T, Hu HP, Hasan S, Patel P, Wada H, Lee D, Fujino K, Hwang DM, Cypel M, de Perrot M, Pierre A, Darling G, Waddell TK, Keshavjee S, Yasufuku K. Evaluation of a New Ultrasound Thoracoscope for Localization of Lung Nodules in Ex Vivo Human Lungs. Ann Thorac Surg. 2017 Mar;103(3):926-934. doi: 10.1016/j.athoracsur.2016.08.031. Epub 2016 Oct 17.
  PMID: 27765176
  citation: Yamamoto M, Takeo M, Meguro F, Ishikawa T. Sonographic evaluation for peripheral pulmonary nodules during video-assisted thoracoscopic surgery. Surg Endosc. 2003 May;17(5):825-7. doi: 10.1007/s00464-002-8900-0. Epub 2003 Jan 18.
  PMID: 12584601
  citation: Sortini D, Feo CV, Carcoforo P, Carrella G, Pozza E, Liboni A, Sortini A. Thoracoscopic localization techniques for patients with solitary pulmonary nodule and history of malignancy. Ann Thorac Surg. 2005 Jan;79(1):258-62; discussion 262. doi: 10.1016/j.athoracsur.2004.06.012.
  PMID: 15620953
  citation: Wada H, Anayama T, Hirohashi K, Nakajima T, Kato T, Waddell TK, Keshavjee S, Yoshino I, Yasufuku K. Thoracoscopic ultrasonography for localization of subcentimetre lung nodules. Eur J Cardiothorac Surg. 2016 Feb;49(2):690-7. doi: 10.1093/ejcts/ezv124. Epub 2015 Apr 7.
  PMID: 25855597
  citation: Santambrogio R, Montorsi M, Bianchi P, Mantovani A, Ghelma F, Mezzetti M. Intraoperative ultrasound during thoracoscopic procedures for solitary pulmonary nodules. Ann Thorac Surg. 1999 Jul;68(1):218-22. doi: 10.1016/s0003-4975(99)00459-2.
  PMID: 10421144
  citation: Matsunaga T, Suzuki K, Takamochi K, Oh S. What is the radiological definition of part-solid tumour in lung cancer?dagger. Eur J Cardiothorac Surg. 2017 Feb 1;51(2):242-247. doi: 10.1093/ejcts/ezw344.
  PMID: 28119328
  citation: Hou YL, Wang YD, Guo HQ, Zhang Y, Guo Y, Han H. Ultrasound location of pulmonary nodules in video-assisted thoracoscopic surgery for precise sublobectomy. Thorac Cancer. 2020 May;11(5):1354-1360. doi: 10.1111/1759-7714.13384. Epub 2020 Mar 17.
  PMID: 32180358
  citation: Zhang Y, Fu F, Chen H. Management of Ground-Glass Opacities in the Lung Cancer Spectrum. Ann Thorac Surg. 2020 Dec;110(6):1796-1804. doi: 10.1016/j.athoracsur.2020.04.094. Epub 2020 Jun 7.
  PMID: 32525031
  citation: Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.
  PMID: 33538338
  responsible party type: Principal Investigator
  investigator affiliation: Peking Union Medical College Hospital
  investigator full name: Xuehan Gao
  investigator title: MD
  sharing ipd: Yes
  ipd description: Study protocol, SAP, and ICF could be shared.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd time frame: 6 months after the trial finnshed.
  ipd access criteria: Contact investigators by email (GXH: gaoxh1299@163.com, GYJ: 610066214@qq.com).