<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/NCT04409990</url>
  </required_header>
  <id_info>
    <org_study_id>SWE of rectal lesions</org_study_id>
    <nct_id>NCT04409990</nct_id>
  </id_info>
  <brief_title>Shear Wave Elastography of Rectal Adenomas and Cancer</brief_title>
  <official_title>Shear Wave Elastography of Rectal Adenomas and Cancer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Vejle Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Vejle Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The diagnosis of rectal lesions is a challenging task, and the accuracy of the primary&#xD;
      staging is important preoperatively. A relatively novel technology makes it possible to&#xD;
      measure the tissue stiffness during endorectal ultrasonography.&#xD;
&#xD;
      The purpose of this study is to evaluate the diagnostic value of Shear Wave Elastography&#xD;
      (SWE). The hypothesis is that the tissue stiffness is higher in malignant tissue than in&#xD;
      benign lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will include patients with an endoscopy verified rectal lesion referred to the&#xD;
      radiology department for pretreatment evaluation.&#xD;
&#xD;
      During the investigation, patients will undergo magnetic resonance imaging (MRI) and&#xD;
      endorectal ultrasonography (ERUS). During the ERUS, the tissue stiffness of the lesion and&#xD;
      visible lymph nodes will be measured using the SWE technology.&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. Tumour stiffness measurement by SWE gives a statistically significantly higher value in&#xD;
           malignant processes than in benign rectal tumors.&#xD;
&#xD;
        2. Tissue stiffness measurement with SWE gives a statistically significantly higher value&#xD;
           in lymph node metastases than in reactive enlarged lymph nodes.&#xD;
&#xD;
        3. There is a statistically significant correlation between SWE and MRI apparent diffusion&#xD;
           coefficient (ADC)&#xD;
&#xD;
      Histopathology report of surgical specimen will serve as endpoint.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 2, 2020</start_date>
  <completion_date type="Actual">October 1, 2022</completion_date>
  <primary_completion_date type="Actual">August 31, 2022</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>SWE accuracy</measure>
    <time_frame>1 month</time_frame>
    <description>The accuracy of SWE value as compared with the histopathology report</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>SWE and ADC measurement</measure>
    <time_frame>1 week</time_frame>
    <description>The correlation between ERUS SWE and MRI ADC value</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">164</enrollment>
  <condition>Rectal Neoplasms</condition>
  <condition>Elasticity Imaging Techniques</condition>
  <arm_group>
    <arm_group_label>Shear Wave Elastography</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>SWE value measurement will be added during the ERUS examination.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Shear Wave Elastography</intervention_name>
    <description>SWE value of rectal lesions</description>
    <arm_group_label>Shear Wave Elastography</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults above 18 years of age&#xD;
&#xD;
          -  Rectal lesions discovered during endoscopy&#xD;
&#xD;
          -  Lesions located no more than 15 cm above the anal verge&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-eligibility for MRI (e.g. claustrophobia, implants)&#xD;
&#xD;
          -  Preoperative radiotherapy and/or chemotherapy&#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>Søren R Rafaelsen, DMSc</last_name>
    <role>Study Chair</role>
    <affiliation>Vejle Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Vejle Hospital</name>
      <address>
        <city>Vejle</city>
        <state>Region Of Southern Denmark</state>
        <zip>7100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <reference>
    <citation>Li T, Lu M, Li Y, Li J, Hu Z, Li X, Cheng X, Jiang J, Tan B. Quantitative Elastography of Rectal Lesions: The Value ofShear Wave Elastography in Identifying Benign and Malignant Rectal Lesions. Ultrasound Med Biol. 2019 Jan;45(1):85-92. doi: 10.1016/j.ultrasmedbio.2018.09.008. Epub 2018 Oct 17.</citation>
    <PMID>30342780</PMID>
  </reference>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 27, 2020</study_first_submitted>
  <study_first_submitted_qc>May 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>October 4, 2022</last_update_submitted>
  <last_update_submitted_qc>October 4, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 5, 2022</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>Adenoma</mesh_term>
    <mesh_term>Rectal 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>


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/NCT04409990
org study id: SWE of rectal lesions
nct id: NCT04409990
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The diagnosis of rectal lesions is a challenging task, and the accuracy of the primary
      staging is important preoperatively. A relatively novel technology makes it possible to
      measure the tissue stiffness during endorectal ultrasonography.

      The purpose of this study is to evaluate the diagnostic value of Shear Wave Elastography
      (SWE). The hypothesis is that the tissue stiffness is higher in malignant tissue than in
      benign lesions.
This study will include patients with an endoscopy verified rectal lesion referred to the
      radiology department for pretreatment evaluation.

      During the investigation, patients will undergo magnetic resonance imaging (MRI) and
      endorectal ultrasonography (ERUS). During the ERUS, the tissue stiffness of the lesion and
      visible lymph nodes will be measured using the SWE technology.

      Hypotheses:

        1. Tumour stiffness measurement by SWE gives a statistically significantly higher value in
           malignant processes than in benign rectal tumors.

        2. Tissue stiffness measurement with SWE gives a statistically significantly higher value
           in lymph node metastases than in reactive enlarged lymph nodes.

        3. There is a statistically significant correlation between SWE and MRI apparent diffusion
           coefficient (ADC)

      Histopathology report of surgical specimen will serve as endpoint.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: SWE accuracy
time frame: 1 month
description: The accuracy of SWE value as compared with the histopathology report
measure: SWE and ADC measurement
time frame: 1 week
description: The correlation between ERUS SWE and MRI ADC value
arm group label: Shear Wave Elastography
arm group type: Other
description: SWE value measurement will be added during the ERUS examination.
intervention type: Diagnostic Test
intervention name: Shear Wave Elastography
description: SWE value of rectal lesions
arm group label: Shear Wave Elastography
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Søren R Rafaelsen, DMSc
role: Study Chair
affiliation: Vejle Hospital
facility: 
country: Denmark
citation: Li T, Lu M, Li Y, Li J, Hu Z, Li X, Cheng X, Jiang J, Tan B. Quantitative Elastography of Rectal Lesions: The Value ofShear Wave Elastography in Identifying Benign and Malignant Rectal Lesions. Ultrasound Med Biol. 2019 Jan;45(1):85-92. doi: 10.1016/j.ultrasmedbio.2018.09.008. Epub 2018 Oct 17.
PMID: 30342780
responsible party type: Sponsor
mesh term: Adenoma
mesh term: Rectal Neoplasms
sharing ipd: No