<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/NCT02250287</url>
  </required_header>
  <id_info>
    <org_study_id>14-000866</org_study_id>
    <nct_id>NCT02250287</nct_id>
  </id_info>
  <brief_title>New Quantitive MRI Parameters in Assessing Kidneys of Autosomal Dominant Polycystic Kidney Disease</brief_title>
  <acronym>MRI Pilot</acronym>
  <official_title>Pilot and Feasibility Study: Evaluation of New Quantitative Magnetic Resonance Imaging Parameters in Assessing the Kidneys of Autosomal Dominant Polycystic Kidney Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to establish normal Magnetic Resonance quantitative values&#xD;
      (tissues stiffness, Apparent Diffusion Coefficient values and Blood Oxygen Level&#xD;
      Determination values for both renal cortex and medullary tissues and total renal blood flow)&#xD;
      for young Autosomal Dominant Polycystic Kidney Disease patients with normal renal function,&#xD;
      and normal young adult controls without Autosomal Dominant Polycystic Kidney Disease and&#xD;
      normal renal function.&#xD;
&#xD;
      Hypothesis: Newer Magnetic Resonance quantitative imaging parameters (tissue stiffness,&#xD;
      Apparent Diffusion Coefficient, Blood Oxygen Level Determination levels, Magnetization&#xD;
      Transfer and renal blood flow) will have different values in young adult ADPKD patients as&#xD;
      compared to normal volunteers.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2014</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate renal tissue stiffness</measure>
    <time_frame>baseline</time_frame>
    <description>The renal parenchymal tissue stiffness is measured in kilopascals with magnetic resonance elastography sequence.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Magnetization transfer ratio</measure>
    <time_frame>baseline</time_frame>
    <description>The magnetization transfer ratio of renal tissue is measured with magnetization transfer sequence and expressed as a ratio.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Diffusion</measure>
    <time_frame>baseline</time_frame>
    <description>Diffusion is quantified as apparent diffusion coefficient (x10-3/mm2) in renal tissue is measured with intravoxel incoherent motion imaging (IVIM) sequence and diffusion tensor imaging (DTI).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Perfusion quantified as blood flow in mL/s.</measure>
    <time_frame>baseline</time_frame>
    <description>Perfusion in the renal tissue is measured with arterial spin labeling sequence and phase contrast magnetic resonance angiography.</description>
  </primary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Autosomal Dominant Polycystic Kidney Disease</condition>
  <condition>Kidney Disease</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Ten known ADPKD patients between the ages of 18-30, and 10 normal non-ADPKD volunteers&#xD;
        between the ages of 18-30, who are MRI compatible will be studied. Study participants will&#xD;
        be selected from a list queried from the Polycystic Kidney Disease database.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria ADPKD participants&#xD;
&#xD;
          -  Male and female subjects between 18-30 years of age&#xD;
&#xD;
          -  Diagnosis of ADPKD&#xD;
&#xD;
          -  Glomerular Filtration Rate (GFR) of &gt; or = to 60 mL/min (Chronic Kidney&#xD;
             Disease-Epidemiology Collaboration equation)&#xD;
&#xD;
          -  Ability to provide written, informed consent&#xD;
&#xD;
        Exclusion criteria for ADPKD participants&#xD;
&#xD;
          -  Clinically significant concomitant systemic disease&#xD;
&#xD;
          -  Subjects with Diabetes Mellitus&#xD;
&#xD;
          -  Urinary protein excretion&#xD;
&#xD;
          -  Abnormal urinalysis suggestive of concomitant glomerular disease&#xD;
&#xD;
          -  Subjects having contraindications to, or interference with MRI assessments&#xD;
&#xD;
          -  Subjects with supine blood pressure higher than 140/90 mm Hg or taking blood pressure&#xD;
             medications&#xD;
&#xD;
        Inclusion criteria for Normal Volunteers&#xD;
&#xD;
          -  Male and female subjects between 18-30 years of age&#xD;
&#xD;
          -  Glomerular Filtration Rate (GFR) of &gt; or = to 60 mL/min (Chronic Kidney&#xD;
             Disease-Epidemiology Collaboration equation)&#xD;
&#xD;
          -  Ability to provide written, informed consent&#xD;
&#xD;
        Exclusion criteria for Normal Volunteers&#xD;
&#xD;
          -  Previous personal or family history of kidney disease&#xD;
&#xD;
          -  Clinically significant concomitant systemic disease&#xD;
&#xD;
          -  Subjects with Diabetes Mellitus&#xD;
&#xD;
          -  Urinary protein excretion&#xD;
&#xD;
          -  Abnormal urinalysis suggestive of concomitant glomerular disease&#xD;
&#xD;
          -  Subjects having contraindications to, or interference with MRI assessments&#xD;
&#xD;
          -  Subjects with supine blood pressure higher than 140/90 mm Hg or taking blood pressure&#xD;
             medications&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>30 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sudhakar Venkatesh, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 24, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2014</study_first_posted>
  <last_update_submitted>June 16, 2016</last_update_submitted>
  <last_update_submitted_qc>June 16, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">June 17, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Sudhakar K. Venkatesh, M.D.</investigator_full_name>
    <investigator_title>Primary Investigator</investigator_title>
  </responsible_party>
  <keyword>autosomal dominant polycystic kidney disease</keyword>
  <keyword>magnetic resonance imaging parameters</keyword>
  <keyword>magnetic resonance elastography</keyword>
  <keyword>apparent diffusion coefficient</keyword>
  <keyword>blood oxygen level determinations</keyword>
  <keyword>diffusion weighted imaging</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthrogryposis</mesh_term>
    <mesh_term>Kidney Diseases</mesh_term>
    <mesh_term>Polycystic Kidney Diseases</mesh_term>
    <mesh_term>Polycystic Kidney, Autosomal Dominant</mesh_term>
  </condition_browse>
  <!-- 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/NCT02250287
org study id: 14-000866
nct id: NCT02250287
lead sponsor: 
has dmc: No
The purpose of this study is to establish normal Magnetic Resonance quantitative values
      (tissues stiffness, Apparent Diffusion Coefficient values and Blood Oxygen Level
      Determination values for both renal cortex and medullary tissues and total renal blood flow)
      for young Autosomal Dominant Polycystic Kidney Disease patients with normal renal function,
      and normal young adult controls without Autosomal Dominant Polycystic Kidney Disease and
      normal renal function.

      Hypothesis: Newer Magnetic Resonance quantitative imaging parameters (tissue stiffness,
      Apparent Diffusion Coefficient, Blood Oxygen Level Determination levels, Magnetization
      Transfer and renal blood flow) will have different values in young adult ADPKD patients as
      compared to normal volunteers.
observational model: Case-Control
time perspective: Retrospective
measure: Evaluate renal tissue stiffness
time frame: baseline
description: The renal parenchymal tissue stiffness is measured in kilopascals with magnetic resonance elastography sequence.
measure: Magnetization transfer ratio
time frame: baseline
description: The magnetization transfer ratio of renal tissue is measured with magnetization transfer sequence and expressed as a ratio.
measure: Diffusion
time frame: baseline
description: Diffusion is quantified as apparent diffusion coefficient (x10-3/mm2) in renal tissue is measured with intravoxel incoherent motion imaging (IVIM) sequence and diffusion tensor imaging (DTI).
measure: Perfusion quantified as blood flow in mL/s.
time frame: baseline
description: Perfusion in the renal tissue is measured with arterial spin labeling sequence and phase contrast magnetic resonance angiography.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 30 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sudhakar Venkatesh, MD
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Sudhakar K. Venkatesh, M.D.
investigator title: Primary Investigator
mesh term: Arthrogryposis
mesh term: Kidney Diseases
mesh term: Polycystic Kidney Diseases
mesh term: Polycystic Kidney, Autosomal Dominant