<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/NCT03781284</url>
  </required_header>
  <id_info>
    <org_study_id>360668</org_study_id>
    <nct_id>NCT03781284</nct_id>
  </id_info>
  <brief_title>PET Combined With MRI for Monitoring Inflammatory Activity in Patients With Ulcerative Colitis</brief_title>
  <official_title>Positron Emission Tomography With 18F-fluorodeoxyglucose Combined With MRI for Monitoring Inflammatory Activity in Patients With Ulcerative Colitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universität Duisburg-Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Crohn's and Colitis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universität Duisburg-Essen</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>
      Colonoscopy is considered crucial for the diagnosis and quantification of ulcerative colitis&#xD;
      (UC). However, there are several drawbacks related to the invasiveness, procedure-related&#xD;
      discomfort, risk of bowel perforation (especially in the period of acute inflammation), and&#xD;
      relatively poor patient acceptance. Most patients regard the necessary bowel cleansing as&#xD;
      burdensome. Feasible, accurate and well accepted non-invasive diagnostic techniques are&#xD;
      needed for the determination of inflammatory activity and optimal tailoring of therapy.&#xD;
      Hybrid PET/MRI represents an innovative combination of two established, non-invasive&#xD;
      diagnostic tools: Magnetic resonance imaging (MRI), allowing for anatomic-functional imaging&#xD;
      of the abdomen at high soft tissue contrast and positron emission tomography (PET) utilizing&#xD;
      18F-fluorodeoxyglucose (FDG) a non-invasive tool to monitor glucose metabolism and allowing a&#xD;
      detection and quantification of inflammatory processes. Since MRI has limited sensitivity in&#xD;
      UC and may be hampered by retained stool, a combination with another imaging modality is very&#xD;
      appealing. PET, on the other side provides functional information, yet with limited&#xD;
      anatomical landmarks and is relatively unsusceptible to artifacts associated to retained&#xD;
      stool. In combination, these modalities might provide a valid alternative for the&#xD;
      non-invasive assessment of the inflammatory activity in UC patients without the need for&#xD;
      bowel purgation. It will therefore have to be investigated whether fecal material does impede&#xD;
      the diagnostic quality of the combination of FDG-PET and MRI. For this purpose, the&#xD;
      investigators will include 50 patients with confirmed ulcerative colitis. Dependent on&#xD;
      clinical activity of the inflammation, patients will be randomized to undergo PET/MRI&#xD;
      enterography either with or without prior bowel purgation followed by a colonoscopy.&#xD;
      Inflammatory activity in 7 bowel segments will be analyzed based on PET/MRI with and without&#xD;
      bowel purgation with the results of colonoscopy as standard of reference.&#xD;
&#xD;
      Patient acceptance of PET/MRI with and without bowel purgation as well as colonoscopy will be&#xD;
      compared. PET/MRI with and without bowel cleansing will be compared with regard to diagnostic&#xD;
      accuracy as well as for its patients' acceptance in comparison to colonoscopy.&#xD;
&#xD;
      The investigators hypothesize that PET/MRI will eventually be highly accurate to detect and&#xD;
      monitor inflammatory activity in patients with ulcerative colitis. Additional information&#xD;
      about extra-intestinal findings might also change the therapeutic concept. PET/MRI might&#xD;
      serve as a non-invasive diagnostic option in patients with UC to quantify inflammatory&#xD;
      activity especially when bowel cleansing or colonoscopy is not applicable.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2016</start_date>
  <completion_date type="Actual">October 31, 2018</completion_date>
  <primary_completion_date type="Actual">October 31, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy of PET/MRI with and without bowel purgation</measure>
    <time_frame>24 hours</time_frame>
    <description>Overall segment-based diagnostic accuracy using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sensitivity of PET/MRI with and without bowel purgation in percent</measure>
    <time_frame>24 hours</time_frame>
    <description>Overall segment-based sensitivity using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Specificity of PET/MRI with and without bowel purgation in percent</measure>
    <time_frame>24 hours</time_frame>
    <description>Overall segment-based specificity using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Negative predictive value of PET/MRI with and without bowel purgation in percent</measure>
    <time_frame>24 hours</time_frame>
    <description>Overall segment-based negative predictive value using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Positive predictive value of PET/MRI with and without bowel purgation in percent</measure>
    <time_frame>24 hours</time_frame>
    <description>Overall segment-based positive predictive value using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Optimized cut-offs</measure>
    <time_frame>24 hours</time_frame>
    <description>Optimized cut-offs for PET for each bowel segment using ileocolonoscopy as reference standard for each colon segment will be calculated</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient acceptance</measure>
    <time_frame>24 hours</time_frame>
    <description>18F-FDG PET/MRI without bowel cleansing shows higher patient acceptance than conventional colonoscopy</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Description of extraintestinal findings</measure>
    <time_frame>24 hours</time_frame>
    <description>Extraintestinal findings will be assessed by evaluating PET/MRI images</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Boston Bowel Preparation Scale</measure>
    <time_frame>24 hours</time_frame>
    <description>Bowel Preparation Quality will be assessed for both patient groups</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">53</enrollment>
  <condition>Ulcerative Colitis</condition>
  <arm_group>
    <arm_group_label>PET/MRI with bowel purgation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>PET/MRI without bowel purgation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>[18F]-FDG PET/MRI</intervention_name>
    <arm_group_label>PET/MRI with bowel purgation</arm_group_label>
    <arm_group_label>PET/MRI without bowel purgation</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Colonoscopy</intervention_name>
    <arm_group_label>PET/MRI with bowel purgation</arm_group_label>
    <arm_group_label>PET/MRI without bowel purgation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with confirmed ulcerative colitis verified by the defining symptoms (rectal&#xD;
             bleeding, diarrhea), endoscopy and histopathology&#xD;
&#xD;
          -  clinically indicated colonoscopy and 18F-FDG PET as either initial assessment or&#xD;
             follow- up examination&#xD;
&#xD;
          -  patient age ≥ 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients aged &lt; 18years&#xD;
&#xD;
          -  Patients with MRI contraindications, e.g. presence of cardiac pacemaker, implanted&#xD;
             cardioverter-defibrillator, neurostimulation systems or with claustrophobia.&#xD;
&#xD;
          -  acute renal failure, severe chronic renal failure (calculated glomerular filtration&#xD;
             rate [GFR] &lt; 30 ml/min)&#xD;
&#xD;
          -  allergy to i.v. gadolinium based contrast agents&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>July 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 18, 2018</last_update_submitted>
  <last_update_submitted_qc>December 18, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universität Duisburg-Essen</investigator_affiliation>
    <investigator_full_name>Jost Langhorst</investigator_full_name>
    <investigator_title>Prof. Dr. med.</investigator_title>
  </responsible_party>
  <keyword>[18F]-FDG PET/MR enterography</keyword>
  <keyword>Diagnosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colitis</mesh_term>
    <mesh_term>Colitis, Ulcerative</mesh_term>
    <mesh_term>Ulcer</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/NCT03781284
org study id: 360668
nct id: NCT03781284
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Colonoscopy is considered crucial for the diagnosis and quantification of ulcerative colitis
      (UC). However, there are several drawbacks related to the invasiveness, procedure-related
      discomfort, risk of bowel perforation (especially in the period of acute inflammation), and
      relatively poor patient acceptance. Most patients regard the necessary bowel cleansing as
      burdensome. Feasible, accurate and well accepted non-invasive diagnostic techniques are
      needed for the determination of inflammatory activity and optimal tailoring of therapy.
      Hybrid PET/MRI represents an innovative combination of two established, non-invasive
      diagnostic tools: Magnetic resonance imaging (MRI), allowing for anatomic-functional imaging
      of the abdomen at high soft tissue contrast and positron emission tomography (PET) utilizing
      18F-fluorodeoxyglucose (FDG) a non-invasive tool to monitor glucose metabolism and allowing a
      detection and quantification of inflammatory processes. Since MRI has limited sensitivity in
      UC and may be hampered by retained stool, a combination with another imaging modality is very
      appealing. PET, on the other side provides functional information, yet with limited
      anatomical landmarks and is relatively unsusceptible to artifacts associated to retained
      stool. In combination, these modalities might provide a valid alternative for the
      non-invasive assessment of the inflammatory activity in UC patients without the need for
      bowel purgation. It will therefore have to be investigated whether fecal material does impede
      the diagnostic quality of the combination of FDG-PET and MRI. For this purpose, the
      investigators will include 50 patients with confirmed ulcerative colitis. Dependent on
      clinical activity of the inflammation, patients will be randomized to undergo PET/MRI
      enterography either with or without prior bowel purgation followed by a colonoscopy.
      Inflammatory activity in 7 bowel segments will be analyzed based on PET/MRI with and without
      bowel purgation with the results of colonoscopy as standard of reference.

      Patient acceptance of PET/MRI with and without bowel purgation as well as colonoscopy will be
      compared. PET/MRI with and without bowel cleansing will be compared with regard to diagnostic
      accuracy as well as for its patients' acceptance in comparison to colonoscopy.

      The investigators hypothesize that PET/MRI will eventually be highly accurate to detect and
      monitor inflammatory activity in patients with ulcerative colitis. Additional information
      about extra-intestinal findings might also change the therapeutic concept. PET/MRI might
      serve as a non-invasive diagnostic option in patients with UC to quantify inflammatory
      activity especially when bowel cleansing or colonoscopy is not applicable.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: Diagnostic accuracy of PET/MRI with and without bowel purgation
time frame: 24 hours
description: Overall segment-based diagnostic accuracy using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation
measure: Sensitivity of PET/MRI with and without bowel purgation in percent
time frame: 24 hours
description: Overall segment-based sensitivity using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation
measure: Specificity of PET/MRI with and without bowel purgation in percent
time frame: 24 hours
description: Overall segment-based specificity using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation
measure: Negative predictive value of PET/MRI with and without bowel purgation in percent
time frame: 24 hours
description: Overall segment-based negative predictive value using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation
measure: Positive predictive value of PET/MRI with and without bowel purgation in percent
time frame: 24 hours
description: Overall segment-based positive predictive value using ileocolonoscopy as reference standard will be calculated for PET/MRI with and without bowel purgation
measure: Optimized cut-offs
time frame: 24 hours
description: Optimized cut-offs for PET for each bowel segment using ileocolonoscopy as reference standard for each colon segment will be calculated
measure: Patient acceptance
time frame: 24 hours
description: 18F-FDG PET/MRI without bowel cleansing shows higher patient acceptance than conventional colonoscopy
measure: Description of extraintestinal findings
time frame: 24 hours
description: Extraintestinal findings will be assessed by evaluating PET/MRI images
measure: The Boston Bowel Preparation Scale
time frame: 24 hours
description: Bowel Preparation Quality will be assessed for both patient groups
arm group label: PET/MRI with bowel purgation
arm group type: Experimental
arm group label: PET/MRI without bowel purgation
arm group type: Experimental
intervention type: Diagnostic Test
intervention name: [18F]-FDG PET/MRI
arm group label: PET/MRI with bowel purgation
arm group label: PET/MRI without bowel purgation
intervention type: Diagnostic Test
intervention name: Colonoscopy
arm group label: PET/MRI with bowel purgation
arm group label: PET/MRI without bowel purgation
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Universität Duisburg-Essen
investigator full name: Jost Langhorst
investigator title: Prof. Dr. med.
mesh term: Colitis
mesh term: Colitis, Ulcerative
mesh term: Ulcer
sharing ipd: No