<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/NCT01729169</url>
  </required_header>
  <id_info>
    <org_study_id>SarcoidosisPET</org_study_id>
    <nct_id>NCT01729169</nct_id>
  </id_info>
  <brief_title>Cardiac Sarcoidosis: FDG PET vs. Ga-DOTANOC PET</brief_title>
  <official_title>Diagnosing Cardiac Sarcoidosis Using FDG PET: Optimization</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lars Christian Gormsen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Aarhus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Diagnosing cardiac sarcoidosis has always been challenging: No single imaging modality has&#xD;
      proved effective and cardiac biopsies have a very low sensitivity.&#xD;
      18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET preceded by at least 12 hours of&#xD;
      fasting has previously been demonstrated to have reasonable accuracy, however, in some&#xD;
      patients physiological FDG uptake in the cardiac region hampers correct identification of&#xD;
      sarcoid granulomas. Gallium Ga 68-DOTANOC is a conjugate of the somatostatin analogue&#xD;
      Nal3-octreotide (NOC) and gallium Ga 68-labeled&#xD;
      1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA). We aim to study whether&#xD;
      68Ga-DOTANOC has superior sensitivity and accuracy than 18-FDG PET in diagnosing cardiac&#xD;
      sarcoidosis. In addition, we aim to compare 18-FDG PET preceded by 12 hours fasting with&#xD;
      18-FDG PET during somatostatin blockade of insulin mediated cardiac glucose uptake.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Intervention:&#xD;
&#xD;
        -  Study A: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement (prone&#xD;
           to arrhythmias, cardiac failure, unexplained dyspnea) are studied twice: 1) 18-FDG PET&#xD;
           preceded by 12 hours fasting and 2) 18-FDG PET performed during a 2 hour somatostatin&#xD;
           blockade (300 microgram/hour)/Heparin infusion.&#xD;
&#xD;
        -  Study B: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement are&#xD;
           studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 68Ga-DOTANOC PET&#xD;
           preceded by at least 6 hours fasting.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">January 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Crossover</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Cardiac sarcoidosis - Sensitivity</measure>
    <time_frame>01/01/2015</time_frame>
    <description>Ability to correctly identify patients with cardiac sarcoidosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Myocardial cardiac glucose uptake assessed by Cardiac SUV</measure>
    <time_frame>01/01/2015</time_frame>
    <description>Semiquantitative assessment of myocardial glucose uptake, the Standardized Uptake Value (SUV). Expressed in g/ml.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">19</enrollment>
  <condition>Sarcoidosis</condition>
  <condition>Cardiac Sarcoidosis</condition>
  <arm_group>
    <arm_group_label>Sarcoidosis patients</arm_group_label>
    <description>Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Biopsy proven sarcoidosis&#xD;
&#xD;
          -  Suspected cardiac sarcoidosis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ischemic heart disease&#xD;
&#xD;
          -  Diabetes&#xD;
&#xD;
          -  Cardiomyopathy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Aarhus University Hospital</name>
      <address>
        <city>Aarhus</city>
        <zip>8000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>November 13, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>May 10, 2016</last_update_submitted>
  <last_update_submitted_qc>May 10, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital</investigator_affiliation>
    <investigator_full_name>Lars Christian Gormsen</investigator_full_name>
    <investigator_title>Consultant, MD PhD</investigator_title>
  </responsible_party>
  <keyword>Sarcoidosis</keyword>
  <keyword>Cardiac sarcoidosis</keyword>
  <keyword>18-FDG PET</keyword>
  <keyword>68Ga-DOTANOC PET</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sarcoidosis</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/NCT01729169
org study id: SarcoidosisPET
nct id: NCT01729169
lead sponsor: 
has dmc: No
Diagnosing cardiac sarcoidosis has always been challenging: No single imaging modality has
      proved effective and cardiac biopsies have a very low sensitivity.
      18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET preceded by at least 12 hours of
      fasting has previously been demonstrated to have reasonable accuracy, however, in some
      patients physiological FDG uptake in the cardiac region hampers correct identification of
      sarcoid granulomas. Gallium Ga 68-DOTANOC is a conjugate of the somatostatin analogue
      Nal3-octreotide (NOC) and gallium Ga 68-labeled
      1,4,7,10-tetraazacyclododecane-N,N',N'',N'''-tetraacetic acid (DOTA). We aim to study whether
      68Ga-DOTANOC has superior sensitivity and accuracy than 18-FDG PET in diagnosing cardiac
      sarcoidosis. In addition, we aim to compare 18-FDG PET preceded by 12 hours fasting with
      18-FDG PET during somatostatin blockade of insulin mediated cardiac glucose uptake.
Intervention:

        -  Study A: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement (prone
           to arrhythmias, cardiac failure, unexplained dyspnea) are studied twice: 1) 18-FDG PET
           preceded by 12 hours fasting and 2) 18-FDG PET performed during a 2 hour somatostatin
           blockade (300 microgram/hour)/Heparin infusion.

        -  Study B: Subjects with biopsy proven sarcoidosis suspected of cardiac involvement are
           studied twice: 1) 18-FDG PET preceded by 12 hours fasting and 2) 68Ga-DOTANOC PET
           preceded by at least 6 hours fasting.
observational model: Case-Crossover
time perspective: Prospective
measure: Cardiac sarcoidosis - Sensitivity
time frame: 01/01/2015
description: Ability to correctly identify patients with cardiac sarcoidosis
measure: Myocardial cardiac glucose uptake assessed by Cardiac SUV
time frame: 01/01/2015
description: Semiquantitative assessment of myocardial glucose uptake, the Standardized Uptake Value (SUV). Expressed in g/ml.
arm group label: Sarcoidosis patients
description: Patients with biopsy proven sarcoidosis suspected of having cardiac sarcoidosis
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Sponsor-Investigator
investigator affiliation: Aarhus University Hospital
investigator full name: Lars Christian Gormsen
investigator title: Consultant, MD PhD
mesh term: Sarcoidosis