<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/NCT01671579</url>
  </required_header>
  <id_info>
    <org_study_id>HUM00061688</org_study_id>
    <nct_id>NCT01671579</nct_id>
  </id_info>
  <brief_title>Comparison of Bowel Ultrasound &amp; MR Enterography in the Follow-up of Previously Diagnosed Pediatric Small Bowel Crohn Disease</brief_title>
  <official_title>Comparison of Bowel Ultrasound &amp; MR Enterography in the Follow-up of Previously Diagnosed Pediatric Sm. Bowel Crohn Disease.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Children's Hospital Medical Center, Cincinnati</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Children's Hospital Medical Center, Cincinnati</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To establish the accuracy of bowel ultrasound in the follow-up of known (previously&#xD;
      diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance&#xD;
      imaging technology used to obtain detailed images of the small bowel) as the reference&#xD;
      standard.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      25-30% of individuals with Crohn disease present during childhood or adolescence, and the&#xD;
      incidence is rising. MRE (magnetic resonance enterography) is considered the standard of care&#xD;
      for imaging of pediatric small bowel Crohn's disease. Bowel ultrasound is an emerging&#xD;
      technology for bowel assessment and offers several advantages over MRE, including lower cost,&#xD;
      shorter exam time, and lack of need for sedation and contrast materials and bowel medication.&#xD;
      The researchers goal is to assess the accuracy of bowel ultrasound in the follow-up of known&#xD;
      pediatric small bowel Crohn disease using MRE and the reference standard.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    PI changed institutions&#xD;
  </why_stopped>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">July 2017</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>
  </study_design_info>
  <primary_outcome>
    <measure>Follow-up of known small bowel Crohn disease</measure>
    <time_frame>1 year</time_frame>
    <description>A variety of imaging findings will be documented by ultrasound and correlated with the imaging findings from the clinically ordered MRE exam to determine the efficacy of bowel ultrasound in the follow-up of small bowel Crohn disease in pediatric subjects.</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">33</enrollment>
  <condition>Crohn Disease</condition>
  <arm_group>
    <arm_group_label>Pediatric small bowel Crohn disease</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects with previously diagnosed PSBCD (pediatric small bowel Crohn disease)who are scheduled for a clinically MRE (magnetic resonance enterography)imaging exam.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bowel ultrasound</intervention_name>
    <description>The ultrasound imaging will take place prior to the clinically ordered MRE exam. The subject will be asked to lie on the ultrasound table for approximately 60 minutes while a variety of ultrasound images are completed.</description>
    <arm_group_label>Pediatric small bowel Crohn disease</arm_group_label>
    <other_name>abdominal ultrasound imaging</other_name>
    <other_name>ultrasound elasticity imaging</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>magnetic resonance enterography (MRE)</intervention_name>
    <description>The subject will have a small intravenous (IV) catheter placed in on of their arms before the MRE exam. Medications called Glucagon and MultiHance will be given thru the IV catheter during the imaging study. The glucagon will decrease the movement of the intestines, which helps provide better images of the bowel. MultiHance is a contrast that helps create clearer MRE images. In addition to the MultiHance, the subject will be given an oral contrast medication called VoLumen to drink approximately 45 minutes before the MRE imaging is started. These medications are used for all clinically necessary MRE studies performed in children and adults at the UMHS. The MRE will take approximately 50 to 60 minutes to complete.</description>
    <arm_group_label>Pediatric small bowel Crohn disease</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years of age or younger&#xD;
&#xD;
          -  Subjects with known small bowel Crohn disease undergoing a clinically ordered imaging&#xD;
             follow-up with MR enterography.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with suspected or newly diagnosed Crohn disease&#xD;
&#xD;
          -  Subject who have the following in their body may not undergo MRE imaging:&#xD;
&#xD;
               -  Metal chips/shrapnel&#xD;
&#xD;
               -  Surgical clips&#xD;
&#xD;
               -  Artificial joints&#xD;
&#xD;
               -  Metallic bone plates&#xD;
&#xD;
               -  Prosthetic devices&#xD;
&#xD;
               -  Heart pacemakers&#xD;
&#xD;
               -  Clips in or around the eye balls&#xD;
&#xD;
               -  artificial heart valves&#xD;
&#xD;
               -  Bullet fragments&#xD;
&#xD;
               -  Chemotherapy or insulin pumps&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>10 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jonathan R. Dillman</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Michigan</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Michigan Hospital</name>
      <address>
        <city>Ann Arbor</city>
        <state>Michigan</state>
        <zip>48109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Children's Hospital Medical Center, Cincinnati</investigator_affiliation>
    <investigator_full_name>Jonathan Dillman, MD</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</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/NCT01671579
org study id: HUM00061688
nct id: NCT01671579
lead sponsor: 
has dmc: Yes
To establish the accuracy of bowel ultrasound in the follow-up of known (previously
      diagnosed) pediatric small bowel Crohn disease, using MR Enterography (magnetic resonance
      imaging technology used to obtain detailed images of the small bowel) as the reference
      standard.
25-30% of individuals with Crohn disease present during childhood or adolescence, and the
      incidence is rising. MRE (magnetic resonance enterography) is considered the standard of care
      for imaging of pediatric small bowel Crohn's disease. Bowel ultrasound is an emerging
      technology for bowel assessment and offers several advantages over MRE, including lower cost,
      shorter exam time, and lack of need for sedation and contrast materials and bowel medication.
      The researchers goal is to assess the accuracy of bowel ultrasound in the follow-up of known
      pediatric small bowel Crohn disease using MRE and the reference standard.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Follow-up of known small bowel Crohn disease
time frame: 1 year
description: A variety of imaging findings will be documented by ultrasound and correlated with the imaging findings from the clinically ordered MRE exam to determine the efficacy of bowel ultrasound in the follow-up of small bowel Crohn disease in pediatric subjects.
arm group label: Pediatric small bowel Crohn disease
arm group type: Other
description: Subjects with previously diagnosed PSBCD (pediatric small bowel Crohn disease)who are scheduled for a clinically MRE (magnetic resonance enterography)imaging exam.
intervention type: Procedure
intervention name: Bowel ultrasound
description: The ultrasound imaging will take place prior to the clinically ordered MRE exam. The subject will be asked to lie on the ultrasound table for approximately 60 minutes while a variety of ultrasound images are completed.
arm group label: Pediatric small bowel Crohn disease
other name: abdominal ultrasound imaging
other name: ultrasound elasticity imaging
intervention type: Procedure
intervention name: magnetic resonance enterography (MRE)
description: The subject will have a small intravenous (IV) catheter placed in on of their arms before the MRE exam. Medications called Glucagon and MultiHance will be given thru the IV catheter during the imaging study. The glucagon will decrease the movement of the intestines, which helps provide better images of the bowel. MultiHance is a contrast that helps create clearer MRE images. In addition to the MultiHance, the subject will be given an oral contrast medication called VoLumen to drink approximately 45 minutes before the MRE imaging is started. These medications are used for all clinically necessary MRE studies performed in children and adults at the UMHS. The MRE will take approximately 50 to 60 minutes to complete.
arm group label: Pediatric small bowel Crohn disease
criteria: 
gender: All
minimum age: 10 Years
maximum age: 18 Years
healthy volunteers: No
last name: Jonathan R. Dillman
role: Principal Investigator
affiliation: University of Michigan
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Children's Hospital Medical Center, Cincinnati
investigator full name: Jonathan Dillman, MD
investigator title: Principal Investigator
mesh term: Crohn Disease