<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/NCT03841149</url>
  </required_header>
  <id_info>
    <org_study_id>NI18037J</org_study_id>
    <secondary_id>2018-A01394-51</secondary_id>
    <nct_id>NCT03841149</nct_id>
  </id_info>
  <brief_title>Volume 3D_US Kidney</brief_title>
  <acronym>VolUS3D</acronym>
  <official_title>Measurement of Kidney Volume and Renal Tumor Volume Using 3D-Ultrasound Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</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 measure the volume of the kidney and tumors using 3D-US&#xD;
      acquisition and to correlate these measurements to contrast-enhanced CT or MRI.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Additional objectives are comparison between true volume measurements and volume estimation&#xD;
      using measurements of the three perpendicular diameters, comparison of inter and intra&#xD;
      variability of 3D US measurements with inter and intra variability of 3D CT or MRI&#xD;
      measurements, calculation of 3D and 2D volume measurements during contrast-enhanced US&#xD;
      examination when the injection is performed for clinical routine purposes such as vascular&#xD;
      and extension staging, during interventional procedures such as US guided biopsy targeting&#xD;
      the non-necrotic tumour parenchyma. Concordance between 2D and 3D US acquisitions will be&#xD;
      compared to CT and MRI measurements. Comparison of volume measurements between non-contrast&#xD;
      and contrast-enhanced methods (US, CT and MRI) will be performed. The results will be&#xD;
      compared to renal function before and after tumour treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 29, 2020</start_date>
  <completion_date type="Anticipated">September 29, 2023</completion_date>
  <primary_completion_date type="Anticipated">September 29, 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>3D-US volume measurements</measure>
    <time_frame>1 month</time_frame>
    <description>Kidney and renal tumor</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>2D-US volume measurements</measure>
    <time_frame>1 month</time_frame>
    <description>Kidney and renal tumor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter and intra variability measurements</measure>
    <time_frame>1 month</time_frame>
    <description>Kidney and renal tumor</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>2D and 3D US volume measurements during Contrast-enhanced US (if performed for patient management)</measure>
    <time_frame>1 month</time_frame>
    <description>Kidney and renal tumor</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">80</enrollment>
  <condition>Chronic Kidney Diseases</condition>
  <condition>Renal Tumor</condition>
  <arm_group>
    <arm_group_label>VolUS3D patients</arm_group_label>
    <description>Patients with renal tumour</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ultrasound Imaging</intervention_name>
    <description>3D volume calculation using on-line and off-line softwares</description>
    <arm_group_label>VolUS3D patients</arm_group_label>
    <other_name>3D Ultrasound transducer and fusion imaging</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients (n=80) referred for renal tumour management (including imaging, biopsy or&#xD;
        percutaneous ablation)&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patient (age 18)&#xD;
&#xD;
          -  Absence of participant's opposition&#xD;
&#xD;
          -  No contra-indication to contrast-enhanced CT AND MRI (a single contrast-enhanced&#xD;
             imaging modality is sufficient)&#xD;
&#xD;
          -  Affiliated to Social Security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Contra-indication to both contrast-enhanced CT AND MRI&#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>Jean-Michel Correas, PU-PH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean-Michel Correas, PU-PH</last_name>
    <phone>+33 1 44 49 41 40</phone>
    <email>jean-michel.correas@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Hélène Morel</last_name>
    <phone>+33 1 71 19 63 46</phone>
    <email>helene.morel@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hôpital Necker-Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-Michel Correas, PU-PH</last_name>
      <phone>+33 1 44 49 41 40</phone>
      <email>jean-Michel.correas@aphp.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>December 22, 2021</last_update_submitted>
  <last_update_submitted_qc>December 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>3D Ultrasound volume measurements</keyword>
  <keyword>Renal volume</keyword>
  <keyword>Tumour Volume</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Kidney Neoplasms</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Renal Insufficiency, Chronic</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/NCT03841149
org study id: NI18037J
secondary id: 2018-A01394-51
nct id: NCT03841149
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to measure the volume of the kidney and tumors using 3D-US
      acquisition and to correlate these measurements to contrast-enhanced CT or MRI.
Additional objectives are comparison between true volume measurements and volume estimation
      using measurements of the three perpendicular diameters, comparison of inter and intra
      variability of 3D US measurements with inter and intra variability of 3D CT or MRI
      measurements, calculation of 3D and 2D volume measurements during contrast-enhanced US
      examination when the injection is performed for clinical routine purposes such as vascular
      and extension staging, during interventional procedures such as US guided biopsy targeting
      the non-necrotic tumour parenchyma. Concordance between 2D and 3D US acquisitions will be
      compared to CT and MRI measurements. Comparison of volume measurements between non-contrast
      and contrast-enhanced methods (US, CT and MRI) will be performed. The results will be
      compared to renal function before and after tumour treatment.
observational model: Cohort
time perspective: Prospective
measure: 3D-US volume measurements
time frame: 1 month
description: Kidney and renal tumor
measure: 2D-US volume measurements
time frame: 1 month
description: Kidney and renal tumor
measure: Inter and intra variability measurements
time frame: 1 month
description: Kidney and renal tumor
measure: 2D and 3D US volume measurements during Contrast-enhanced US (if performed for patient management)
time frame: 1 month
description: Kidney and renal tumor
arm group label: VolUS3D patients
description: Patients with renal tumour
intervention type: Other
intervention name: Ultrasound Imaging
description: 3D volume calculation using on-line and off-line softwares
arm group label: VolUS3D patients
other name: 3D Ultrasound transducer and fusion imaging
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Michel Correas, PU-PH
role: Principal Investigator
affiliation: Assistance Publique - Hôpitaux de Paris
last name: Jean-Michel Correas, PU-PH
phone: +33 1 44 49 41 40
email: jean-michel.correas@aphp.fr
last name: Hélène Morel
phone: +33 1 71 19 63 46
email: helene.morel@aphp.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Kidney Neoplasms
mesh term: Kidney Diseases
mesh term: Renal Insufficiency, Chronic
sharing ipd: No