<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/NCT03307694</url>
  </required_header>
  <id_info>
    <org_study_id>IRB00092785</org_study_id>
    <nct_id>NCT03307694</nct_id>
  </id_info>
  <brief_title>Thyroid Ultrasound Elasticity (TrUE) Imaging</brief_title>
  <official_title>Multi-Angle Compound Shear Wave Elasticity Imaging for the Characterization of Thyroid Nodules</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Emory University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Emory University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the researchers will scan the thyroid nodules of patients scheduled for&#xD;
      surgical removal of these nodules. During their preadmission testing, but prior to their&#xD;
      surgery, the researchers will perform standard ultrasound and shear wave elasticity imaging&#xD;
      (SWEI) scans of the thyroid nodules in these patients. Both images can be generated by the&#xD;
      same ultrasound scanner and within the same imaging session without having to switch out any&#xD;
      equipment. The results of the SWEI scans will be compared to the definitive diagnosis from&#xD;
      pathology obtained after pathologists have examined the removed nodules post-operatively.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thyroid ultrasound is a first-line procedure to assess patients with thyroid nodules.&#xD;
      Unfortunately, standard ultrasound has low sensitivity, and thus low positive predictive&#xD;
      value, for malignancy and many patients with thyroid nodules are referred for additional&#xD;
      imaging studies or biopsy. Shear wave elasticity imaging (SWEI) is a non-invasive ultrasound&#xD;
      technology that allows clinicians to assess the stiffness of tissues. In many solid tumors,&#xD;
      increased stiffness is highly specific for underlying malignancy, and preliminary studies&#xD;
      have shown this to be true for thyroid malignancies. Both standard sonography and SWEI can be&#xD;
      performed on the same ultrasound equipment and within the same imaging session. Therefore,&#xD;
      integrating SWEI into standard thyroid diagnostic workflow is a logical approach towards&#xD;
      improving the positive predictive value of these first-line sonographic studies. Other&#xD;
      studies have demonstrated the ability of SWEI techniques to differentiate benign from&#xD;
      malignant thyroid nodules. However, shear wave techniques still need to overcome challenges&#xD;
      before they can be successfully integrated into the clinical paradigm. These techniques still&#xD;
      struggle to accurately classify follicular carcinomas and few have been validated in patients&#xD;
      with multiple thyroid lesions, a scenario which is clinically common. The researchers believe&#xD;
      that a multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on&#xD;
      multiple angled push beams, has the potential to generate more accurate shear wave images in&#xD;
      the context of thyroid imaging. To this end, this study will perform proof-of-concept studies&#xD;
      of MAC-SWEI in thyroid patients undergoing standard ultrasound scans and compare the results&#xD;
      of shear wave images to results from corresponding pathology.&#xD;
&#xD;
      Study participants will undergo a single SWEI session within their normally-scheduled&#xD;
      preadmission testing during which both standard b-mode and shear images of the thyroid&#xD;
      nodule(s) will be acquired. The 36 patients will be randomized to receive MAC-SWEI, standard&#xD;
      SWEI, and ultrasound, or only standard SWEI and ultrasound.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 23, 2017</start_date>
  <completion_date type="Actual">July 13, 2018</completion_date>
  <primary_completion_date type="Actual">July 13, 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Determination of Malignancy by SWEI Imaging</measure>
    <time_frame>Pre-operative visit (within 24 hours before surgery, on average)</time_frame>
    <description>As part of the pre-operative visit, participants will have imaging of their thyroid nodules. Established SWEI and MAC-SWEI techniques will be performed to identify malignant thyroid tissue.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Determination of Malignancy by Pathological Proof</measure>
    <time_frame>Post-surgery (within 10 days after surgery, on average)</time_frame>
    <description>Tissue samples obtained during the participant's thyroid biopsy, thyroidectomy, or cervical node biopsy will be submitted to the pathology lab as part of the clinical standard of care. The pathology report will specify whether or not malignant cells were found in the tissue sample.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accuracy of differentiating benign from malignant lesions between SWEI techniques</measure>
    <time_frame>Pre-operative visit (within 24 hours before surgery, on average)</time_frame>
    <description>The ability of MAC-SWEI to differentiate benign from malignant lesions will be compared to the ability of standard SWEI to make this differentiation.</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">31</enrollment>
  <condition>Cancer, Thyroid</condition>
  <arm_group>
    <arm_group_label>MAC-SWEI, standard SWEI, ultrasound</arm_group_label>
    <description>Participants in this group will receive all three imaging techniques</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard SWEI, ultrasound</arm_group_label>
    <description>Participants in this group will receive two imaging techniques</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasound</intervention_name>
    <description>All ultrasound images will be acquired by an in-house ultrasound technologist using a Verasonics Vantage (Verasonics Inc., Kirkland, Washington, USA) ultrasound system. During imaging, the technologist will position the Verasonics transducer, under b-mode guidance, in planes overlying the thyroid nodules approximating those obtained during previous clinical ultrasound scans.</description>
    <arm_group_label>MAC-SWEI, standard SWEI, ultrasound</arm_group_label>
    <arm_group_label>Standard SWEI, ultrasound</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Shear wave elasticity imaging</intervention_name>
    <description>Shear wave elasticity imaging (SWEI) is obtained during the standard ultrasound session. The generation of shear wave images consists of two important steps called &quot;pushing&quot; and &quot;tracking&quot;. First, in the &quot;pushing&quot; mode, a long focused ultrasound beam is transmitted to perturb tissue, generating ultrasonic shear waves in tissue that propagate perpendicular to the direction of pushing. In the &quot;tracking&quot; mode, shear wave propagation is observed and recorded. Because the speed of shear waves is a function of Young's modulus, these data reveal information about the stiffness of underlying biological tissue.</description>
    <arm_group_label>MAC-SWEI, standard SWEI, ultrasound</arm_group_label>
    <arm_group_label>Standard SWEI, ultrasound</arm_group_label>
    <other_name>SWEI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Multi-angle compound shear wave elasticity imaging</intervention_name>
    <description>The multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on multiple angled push beams, has the potential to generate more accurate shear wave images in the context of thyroid imaging. To assess the MAC-SWEI technique, shear wave images will be used to generate estimates of the relative stiffness of lesions via their normalized Young's modulus.</description>
    <arm_group_label>MAC-SWEI, standard SWEI, ultrasound</arm_group_label>
    <other_name>MAC-SWEI</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Study participants will be recruited from patients of the Emory Healthcare system who are&#xD;
        scheduled to have a thyroid biopsy, thyroidectomy, or cervical node biopsy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18 years old&#xD;
&#xD;
          -  Scheduled to undergo a thyroid biopsy, thyroidectomy, or cervical node biopsy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stanislav Emelianov, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Emory University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Emory Univeristy Hospital Midtown</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 12, 2017</study_first_posted>
  <last_update_submitted>December 1, 2019</last_update_submitted>
  <last_update_submitted_qc>December 1, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Emory University</investigator_affiliation>
    <investigator_full_name>Stanislav Emelianov</investigator_full_name>
    <investigator_title>Adjunct Professor</investigator_title>
  </responsible_party>
  <keyword>Cancer</keyword>
  <keyword>Thyroid nodule</keyword>
  <keyword>Imaging</keyword>
  <keyword>Radiology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thyroid Neoplasms</mesh_term>
    <mesh_term>Thyroid Diseases</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/NCT03307694
org study id: IRB00092785
nct id: NCT03307694
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
In this study the researchers will scan the thyroid nodules of patients scheduled for
      surgical removal of these nodules. During their preadmission testing, but prior to their
      surgery, the researchers will perform standard ultrasound and shear wave elasticity imaging
      (SWEI) scans of the thyroid nodules in these patients. Both images can be generated by the
      same ultrasound scanner and within the same imaging session without having to switch out any
      equipment. The results of the SWEI scans will be compared to the definitive diagnosis from
      pathology obtained after pathologists have examined the removed nodules post-operatively.
Thyroid ultrasound is a first-line procedure to assess patients with thyroid nodules.
      Unfortunately, standard ultrasound has low sensitivity, and thus low positive predictive
      value, for malignancy and many patients with thyroid nodules are referred for additional
      imaging studies or biopsy. Shear wave elasticity imaging (SWEI) is a non-invasive ultrasound
      technology that allows clinicians to assess the stiffness of tissues. In many solid tumors,
      increased stiffness is highly specific for underlying malignancy, and preliminary studies
      have shown this to be true for thyroid malignancies. Both standard sonography and SWEI can be
      performed on the same ultrasound equipment and within the same imaging session. Therefore,
      integrating SWEI into standard thyroid diagnostic workflow is a logical approach towards
      improving the positive predictive value of these first-line sonographic studies. Other
      studies have demonstrated the ability of SWEI techniques to differentiate benign from
      malignant thyroid nodules. However, shear wave techniques still need to overcome challenges
      before they can be successfully integrated into the clinical paradigm. These techniques still
      struggle to accurately classify follicular carcinomas and few have been validated in patients
      with multiple thyroid lesions, a scenario which is clinically common. The researchers believe
      that a multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on
      multiple angled push beams, has the potential to generate more accurate shear wave images in
      the context of thyroid imaging. To this end, this study will perform proof-of-concept studies
      of MAC-SWEI in thyroid patients undergoing standard ultrasound scans and compare the results
      of shear wave images to results from corresponding pathology.

      Study participants will undergo a single SWEI session within their normally-scheduled
      preadmission testing during which both standard b-mode and shear images of the thyroid
      nodule(s) will be acquired. The 36 patients will be randomized to receive MAC-SWEI, standard
      SWEI, and ultrasound, or only standard SWEI and ultrasound.
observational model: Other
time perspective: Prospective
measure: Determination of Malignancy by SWEI Imaging
time frame: Pre-operative visit (within 24 hours before surgery, on average)
description: As part of the pre-operative visit, participants will have imaging of their thyroid nodules. Established SWEI and MAC-SWEI techniques will be performed to identify malignant thyroid tissue.
measure: Determination of Malignancy by Pathological Proof
time frame: Post-surgery (within 10 days after surgery, on average)
description: Tissue samples obtained during the participant's thyroid biopsy, thyroidectomy, or cervical node biopsy will be submitted to the pathology lab as part of the clinical standard of care. The pathology report will specify whether or not malignant cells were found in the tissue sample.
measure: Accuracy of differentiating benign from malignant lesions between SWEI techniques
time frame: Pre-operative visit (within 24 hours before surgery, on average)
description: The ability of MAC-SWEI to differentiate benign from malignant lesions will be compared to the ability of standard SWEI to make this differentiation.
arm group label: MAC-SWEI, standard SWEI, ultrasound
description: Participants in this group will receive all three imaging techniques
arm group label: Standard SWEI, ultrasound
description: Participants in this group will receive two imaging techniques
intervention type: Diagnostic Test
intervention name: Ultrasound
description: All ultrasound images will be acquired by an in-house ultrasound technologist using a Verasonics Vantage (Verasonics Inc., Kirkland, Washington, USA) ultrasound system. During imaging, the technologist will position the Verasonics transducer, under b-mode guidance, in planes overlying the thyroid nodules approximating those obtained during previous clinical ultrasound scans.
arm group label: MAC-SWEI, standard SWEI, ultrasound
arm group label: Standard SWEI, ultrasound
intervention type: Diagnostic Test
intervention name: Shear wave elasticity imaging
description: Shear wave elasticity imaging (SWEI) is obtained during the standard ultrasound session. The generation of shear wave images consists of two important steps called "pushing" and "tracking". First, in the "pushing" mode, a long focused ultrasound beam is transmitted to perturb tissue, generating ultrasonic shear waves in tissue that propagate perpendicular to the direction of pushing. In the "tracking" mode, shear wave propagation is observed and recorded. Because the speed of shear waves is a function of Young's modulus, these data reveal information about the stiffness of underlying biological tissue.
arm group label: MAC-SWEI, standard SWEI, ultrasound
arm group label: Standard SWEI, ultrasound
other name: SWEI
intervention type: Diagnostic Test
intervention name: Multi-angle compound shear wave elasticity imaging
description: The multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on multiple angled push beams, has the potential to generate more accurate shear wave images in the context of thyroid imaging. To assess the MAC-SWEI technique, shear wave images will be used to generate estimates of the relative stiffness of lesions via their normalized Young's modulus.
arm group label: MAC-SWEI, standard SWEI, ultrasound
other name: MAC-SWEI
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stanislav Emelianov, PhD
role: Principal Investigator
affiliation: Emory University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Emory University
investigator full name: Stanislav Emelianov
investigator title: Adjunct Professor
mesh term: Thyroid Neoplasms
mesh term: Thyroid Diseases
sharing ipd: No