<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/NCT03821376</url>
  </required_header>
  <id_info>
    <org_study_id>1901057253</org_study_id>
    <nct_id>NCT03821376</nct_id>
  </id_info>
  <brief_title>Correlation of Renal Mass Pathologic Grade and Contrast Enhanced Ultrasound (CEUS)</brief_title>
  <official_title>Correlation of Contrast Enhanced Ultrasound of Renal Masses With Pathologic Grade: A Prospective Comparison of Quantitative and Qualitative Findings</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Indiana University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Indiana University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Patients with renal lesions suspicious for renal cell carcinoma (RCC) have a variety of&#xD;
      different treatment pathways available to them. Imaging surveillance is being used frequently&#xD;
      on smaller renal masses, and radiologists are being asked to biopsy more renal lesions to&#xD;
      better guide decision making by urology. This is in large part due to the pathologic grade of&#xD;
      renal masses having been shown to correlate with patient outcomes. The World Health&#xD;
      Organization (WHO) or Fuhrman grade is the standard grading scale used by pathologists for&#xD;
      RCC. The goal of this study will be to correlate contrast enhanced ultrasound findings with&#xD;
      the pathologic grade of RCC. Specifically, the investigators hypothesize that tumors with&#xD;
      different pathologic grades will show different patterns of qualitative enhancement, as well&#xD;
      as different perfusion kinetics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Renal malignancies are relatively common, with lifetime risk ranging from 1 in 48 in men to 1&#xD;
      in 83 in women, of which RCC is the most common. RCC comes in a variety of subtypes, and&#xD;
      pathologic grade has been shown to be one factor that correlates with patient prognosis&#xD;
      [Novara et al]. The most commonly used pathologic grading systems are the WHO or Fuhrman&#xD;
      scale, which rely on histologic features of the tumor such as nuclear size, irregularity, and&#xD;
      nucleolar prominence.&#xD;
&#xD;
      Care of patients with RCC depends on a number of factors, including size and pathologic&#xD;
      grade. As such, radiologic surveillance with CT and MRI is common, and percutaneous biopsy of&#xD;
      renal masses for the purpose of pathologic grading is also relatively common. While&#xD;
      percutaneous biopsy of renal masses is the least invasive way to obtain tissue, these still&#xD;
      carry risks, especially of hemorrhage give the vascular nature of the kidneys and RCC.&#xD;
&#xD;
      Contrast enhanced ultrasound has been shown to have the ability to differentiate renal masses&#xD;
      from normal background renal parenchyma [Barr et al]. It has the unique ability to be used in&#xD;
      patients with renal dysfunction as it is excreted by the liver and lungs. As such, it is well&#xD;
      suited for use in patients with underlying renal pathology. This study will aim to use&#xD;
      contrast enhanced ultrasound to evaluate the qualitative and quantitative features of renal&#xD;
      masses prior to surgical removal, and then evaluate for correlation of these features with&#xD;
      pathologic grading following surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">July 16, 2019</start_date>
  <completion_date type="Anticipated">July 1, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2025</primary_completion_date>
  <phase>Phase 4</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>Imaging findings for enrolled patients will be compared to pathologic grading</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Imaging reviewers will be blinded to pathologic grade</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Correlation of contrast enhanced ultrasound features of renal masses with pathologic grade</measure>
    <time_frame>first 6 months</time_frame>
    <description>Ultrasound images will be reviewed for qualitative imaging features as well as quantitative post contrast features (time to peak, area under the curve, mean transit time etc). These findings will then be correlated with the pathologic grade of surgically removed renal masses, to evaluate for differences in imaging features among the different pathologic grades.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Renal Malignant Tumor</condition>
  <arm_group>
    <arm_group_label>Renal malignancy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Contrast enhanced ultrasound with Lumason</intervention_name>
    <description>Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass).</description>
    <arm_group_label>Renal malignancy</arm_group_label>
    <other_name>Ultrasound</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Greater than or equal to 18 years of age&#xD;
&#xD;
          -  Previously identified renal mass with radiology and clinical features consistent with&#xD;
             RCC&#xD;
&#xD;
          -  Clinical care plan includes partial or total nephrectomy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Less than 18 years of age&#xD;
&#xD;
          -  Currently pregnant&#xD;
&#xD;
          -  Renal mass with clinical care plan that does not include nephrectomy&#xD;
&#xD;
          -  Renal mass suspected to be non RCC neoplasm by imaging and clinical data&#xD;
&#xD;
          -  Renal mass unable to be visualized by grayscale ultrasound&#xD;
&#xD;
          -  Known renal vein thrombosis&#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>Jordan Swennson, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Indiana University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jordan Swensson, MD</last_name>
    <phone>317-944-1837</phone>
    <email>jswensso@iu.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Marissa Agoston, B.S.</last_name>
    <phone>317-963-4762</phone>
    <email>magoston@iu.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Indiana University Hospital</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46022</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marissa Agoston</last_name>
      <phone>317-963-4762</phone>
      <email>magoston@iu.edu</email>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 28, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>July 14, 2023</last_update_submitted>
  <last_update_submitted_qc>July 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 17, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Indiana University</investigator_affiliation>
    <investigator_full_name>Jordan K. Swensson</investigator_full_name>
    <investigator_title>Assistant Professor of Clinical Radiology</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Carcinoma, Renal Cell</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/NCT03821376
org study id: 1901057253
nct id: NCT03821376
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
Patients with renal lesions suspicious for renal cell carcinoma (RCC) have a variety of
      different treatment pathways available to them. Imaging surveillance is being used frequently
      on smaller renal masses, and radiologists are being asked to biopsy more renal lesions to
      better guide decision making by urology. This is in large part due to the pathologic grade of
      renal masses having been shown to correlate with patient outcomes. The World Health
      Organization (WHO) or Fuhrman grade is the standard grading scale used by pathologists for
      RCC. The goal of this study will be to correlate contrast enhanced ultrasound findings with
      the pathologic grade of RCC. Specifically, the investigators hypothesize that tumors with
      different pathologic grades will show different patterns of qualitative enhancement, as well
      as different perfusion kinetics.
Renal malignancies are relatively common, with lifetime risk ranging from 1 in 48 in men to 1
      in 83 in women, of which RCC is the most common. RCC comes in a variety of subtypes, and
      pathologic grade has been shown to be one factor that correlates with patient prognosis
      [Novara et al]. The most commonly used pathologic grading systems are the WHO or Fuhrman
      scale, which rely on histologic features of the tumor such as nuclear size, irregularity, and
      nucleolar prominence.

      Care of patients with RCC depends on a number of factors, including size and pathologic
      grade. As such, radiologic surveillance with CT and MRI is common, and percutaneous biopsy of
      renal masses for the purpose of pathologic grading is also relatively common. While
      percutaneous biopsy of renal masses is the least invasive way to obtain tissue, these still
      carry risks, especially of hemorrhage give the vascular nature of the kidneys and RCC.

      Contrast enhanced ultrasound has been shown to have the ability to differentiate renal masses
      from normal background renal parenchyma [Barr et al]. It has the unique ability to be used in
      patients with renal dysfunction as it is excreted by the liver and lungs. As such, it is well
      suited for use in patients with underlying renal pathology. This study will aim to use
      contrast enhanced ultrasound to evaluate the qualitative and quantitative features of renal
      masses prior to surgical removal, and then evaluate for correlation of these features with
      pathologic grading following surgery.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Imaging findings for enrolled patients will be compared to pathologic grading
primary purpose: Diagnostic
masking: None (Open Label)
masking description: Imaging reviewers will be blinded to pathologic grade
measure: Correlation of contrast enhanced ultrasound features of renal masses with pathologic grade
time frame: first 6 months
description: Ultrasound images will be reviewed for qualitative imaging features as well as quantitative post contrast features (time to peak, area under the curve, mean transit time etc). These findings will then be correlated with the pathologic grade of surgically removed renal masses, to evaluate for differences in imaging features among the different pathologic grades.
arm group label: Renal malignancy
arm group type: Experimental
description: Patients with renal mass(es) identified by cross sectional imaging, specifically ultrasound following the intravenous injection of Lumason
intervention type: Drug
intervention name: Contrast enhanced ultrasound with Lumason
description: Following consent, they will undergo contrast enhanced ultrasound of their known renal mass(es). This will be performed at University hospital following intravenous administration of Lumason (2.5 mL per injection, maximum of 2 injections per mass).
arm group label: Renal malignancy
other name: Ultrasound
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jordan Swennson, MD
role: Principal Investigator
affiliation: Indiana University
last name: Jordan Swensson, MD
phone: 317-944-1837
email: jswensso@iu.edu
last name: Marissa Agoston, B.S.
phone: 317-963-4762
email: magoston@iu.edu
facility: 
status: Recruiting
contact: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Indiana University
investigator full name: Jordan K. Swensson
investigator title: Assistant Professor of Clinical Radiology
mesh term: Carcinoma, Renal Cell
sharing ipd: No