<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/NCT04424472</url>
  </required_header>
  <id_info>
    <org_study_id>STUDY00145327</org_study_id>
    <nct_id>NCT04424472</nct_id>
  </id_info>
  <brief_title>Assessing the Utility of Ultrasound Compared to Cross-Sectional Imaging in the Follow-up of Patients With Renal Cell Carcinoma</brief_title>
  <official_title>Assessing the Utility of Ultrasound Compared to Cross-Sectional Imaging in the Follow-up of Patients With Renal Cell Carcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Kansas Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Kansas Medical Center</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 aim of this study is to determine the utility of renal ultrasonography (US) in the&#xD;
      detection of abdominal recurrences after definitive therapy for renal cell carcinoma (RCC)&#xD;
      and compare the detection rate to that of cross-sectional imaging.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 17, 2020</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">June 1, 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>
    <masking_description>The sonographer for the additional ultrasound will be blinded as will be the blinded radiology who will compare the US to the most recent negative CT/MRI to determine if recurrence is visualized by US</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Utility of Renal Ultrasonography (US) in the detection of abdominal recurrences</measure>
    <time_frame>4 weeks</time_frame>
    <description>Renal Cell Carcinoma (RCC) recurrence detection of ultrasonography in patients who have undergo definitive therapy for RCC compared to detection rate of cross-sectional imaging</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiation Burden</measure>
    <time_frame>5 years</time_frame>
    <description>Compare the average radiation exposure over 5 years for patients on current standard of care imaging surveillance for RCC, which consists of both ultrasound and cross-sectional imaging, to that of patients who would only receive cross-section imaging surveillance for RCC. This would yield overall increase in radiation burden for patients with RCC</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Renal Cell Carcinoma</condition>
  <arm_group>
    <arm_group_label>Ultrasonography</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patient will be scheduled to undergo an additional US by a blinded sonographer within 4 weeks of their most recent cross-sectional imaging that indicated a recurrence</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Ultrasonography</intervention_name>
    <description>Abdominal Ultrasonography</description>
    <arm_group_label>Ultrasonography</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients must be 18 year of age or older.&#xD;
&#xD;
          -  Patients having undergone radical or partial nephrectomy for the indication of renal&#xD;
             cell carcinoma.&#xD;
&#xD;
          -  Most recent imaging study must have been either computed tomography (CT) or magnetic&#xD;
             resonance imaging (MRI).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with pT4 disease (tumor invades beyond the Gerota fascia: including&#xD;
             contiguous extension into the ipsilateral adrenal gland).&#xD;
&#xD;
          -  Patients with metastatic disease prior to time of surgery requiring systemic&#xD;
             treatment.&#xD;
&#xD;
          -  Patients with another active cancer diagnosis requiring systemic treatment.&#xD;
&#xD;
          -  Patients with contrast allergies.&#xD;
&#xD;
          -  Patients with baseline chronic kidney disease (GFR &lt; 45 ml/min/1.73 m2).&#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_contact>
    <last_name>Katherine Glavin</last_name>
    <phone>913-588-8721</phone>
    <email>kglavin@kumc.edu</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Kansas Health System</name>
      <address>
        <city>Kansas City</city>
        <state>Kansas</state>
        <zip>66160</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>June 2, 2020</study_first_submitted>
  <study_first_submitted_qc>June 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>August 31, 2020</last_update_submitted>
  <last_update_submitted_qc>August 31, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2020</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>Carcinoma</mesh_term>
    <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/NCT04424472
org study id: STUDY00145327
nct id: NCT04424472
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to determine the utility of renal ultrasonography (US) in the
      detection of abdominal recurrences after definitive therapy for renal cell carcinoma (RCC)
      and compare the detection rate to that of cross-sectional imaging.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
masking description: The sonographer for the additional ultrasound will be blinded as will be the blinded radiology who will compare the US to the most recent negative CT/MRI to determine if recurrence is visualized by US
measure: Utility of Renal Ultrasonography (US) in the detection of abdominal recurrences
time frame: 4 weeks
description: Renal Cell Carcinoma (RCC) recurrence detection of ultrasonography in patients who have undergo definitive therapy for RCC compared to detection rate of cross-sectional imaging
measure: Radiation Burden
time frame: 5 years
description: Compare the average radiation exposure over 5 years for patients on current standard of care imaging surveillance for RCC, which consists of both ultrasound and cross-sectional imaging, to that of patients who would only receive cross-section imaging surveillance for RCC. This would yield overall increase in radiation burden for patients with RCC
arm group label: Ultrasonography
arm group type: Experimental
description: Patient will be scheduled to undergo an additional US by a blinded sonographer within 4 weeks of their most recent cross-sectional imaging that indicated a recurrence
intervention type: Diagnostic Test
intervention name: Ultrasonography
description: Abdominal Ultrasonography
arm group label: Ultrasonography
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Katherine Glavin
phone: 913-588-8721
email: kglavin@kumc.edu
facility: 
status: Recruiting
country: United States
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Carcinoma, Renal Cell
sharing ipd: No