<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/NCT03038386</url>
  </required_header>
  <id_info>
    <org_study_id>NL54454.100.15</org_study_id>
    <nct_id>NCT03038386</nct_id>
  </id_info>
  <brief_title>Diagnostic Value of DECT Scan Compared to Diagnostic Needle Aspiration</brief_title>
  <acronym>DEteCT</acronym>
  <official_title>Diagnostic Value of DECT Scan Compared to Diagnostic Needle Aspiration</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Meander Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Meander Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Rationale: Gout is a disease with growing incidence and complexity due to increased life&#xD;
      expectancy, co-morbidity and medication. The disease can be diagnosed by microscopy,&#xD;
      demonstrating monosodium uric acid (MSU) in synovial fluid of the affected joint or in tophi&#xD;
      (subcutaneous or peritendinous MSU depositions). In daily practice, however, the diagnosis is&#xD;
      difficult to ascertain due to sampling error (no synovial fluid acquired because the needle&#xD;
      was not exactly placed in the affected joint, or the location of the gout might have been&#xD;
      extra-articular e.g. around tendons) or to a different cause of acute arthritis (e.g.&#xD;
      infection, reactive arthritis). Recently, Dual Energy CT scan has become available. This&#xD;
      technique allows the visualization and quantification of MSU. Although imaging modalities&#xD;
      such as DECT show promise in the classification of gout, the studies to date have been small&#xD;
      and have primarily involved people with established disease.&#xD;
&#xD;
      A study with cross-sectional design in which patients for whom the clinical questions &quot;does&#xD;
      this patient have gout?&quot; are referred for participation may contribute to assess the value of&#xD;
      DECT scan in diagnosing acute arthritis caused by gout.&#xD;
&#xD;
      Objective: Assessment of value of DECT scan in diagnosing acute arthritis, caused by gout.&#xD;
&#xD;
      Study design: Prospective Study population: Patients with acute mono or oligo arthritis&#xD;
      without prior diagnosis, the rheumatologist has an indication for diagnostic needle&#xD;
      aspiration.&#xD;
&#xD;
      Nature and extent of the burden and risks associated with participation, benefit and group&#xD;
      relatedness: In current daily practice, patients with acute mono- or oligo-arthritis without&#xD;
      prior diagnosis undergo a diagnostic aspiration of the affected joint. This can be done by&#xD;
      blind aspiration or ultra sound guided aspiration depending on the judgement of the&#xD;
      rheumatologist. The aspirated synovial fluid is then assessed by polarized microscopy to&#xD;
      detect MSU crystals. The diagnostic value of DECT in acute gout attacks had not yet been&#xD;
      established and is therefore not used in daily practice. In this study all patients undergo&#xD;
      DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If&#xD;
      the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained&#xD;
      prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound&#xD;
      guided aspiration will take place, with knowledge of DECT results, followed by repeat&#xD;
      microscopy&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2016</start_date>
  <completion_date type="Anticipated">June 2019</completion_date>
  <primary_completion_date type="Actual">December 2018</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>The sensitivity and specificity (95% CI) of DECT scanning for the detection of MSU deposits</measure>
    <time_frame>2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical and laboratory predicators of positive DECT scan in patients with acute mono or oligo arthritis</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants, in whom the first aspirate demonstrated no MSU and/or no synovial fluid, with MSU demonstrated after ultrasound guided joint aspiration</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of participants with positive DECT lesions, in whom the first aspirate(s) demonstrated no MSU and/or no synovial fluid with MSU demonstrated after ultrasound guided joint aspiration at the place of positive DECT lesion</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>cost of the gout diagnostic strategies (blind joint aspiration, ultrasound guided joint aspiration, DECT) will be calculated</measure>
    <time_frame>2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient satisfaction: What does the patient experience as the most patient-friendly way of diagnosing gout: DECT scan, ultrasound-guided joint aspiration or blind aspiration?</measure>
    <time_frame>2 weeks</time_frame>
    <description>VAS DECT, blind joint aspiration, ultrasound guided joint aspiration</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>correlation between cardiovascular risk and the urate volume on DECT</measure>
    <time_frame>2 weeks</time_frame>
    <description>correlation coefficient between cardiovascular risk (SCORE European and ACC/AHA) and the urate volume on DECT</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients with clinical diagnosis gout 6 and 12 month after het DECT</measure>
    <time_frame>6 and 12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of patients on urate lowering medication 6 and 12 month after the DECT</measure>
    <time_frame>6 and 12 month</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Gout</condition>
  <arm_group>
    <arm_group_label>Dual Energy CT</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this study all patients undergo DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound guided aspiration will take place, with knowledge of DECT results, followed by repeat microscopy</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Dual Energy CT</intervention_name>
    <description>In this study all patients undergo DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound guided aspiration will take place, with knowledge of DECT results, followed by repeat microscopy</description>
    <arm_group_label>Dual Energy CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
          -  Mono or oligo arthritis (2-3 swollen joints)&#xD;
&#xD;
          -  Indication for diagnostic aspiration of an inflamed joint in which gout is one of the&#xD;
             possibilities&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Polyarthritis ( up to 4 swollen joint);&#xD;
&#xD;
          -  Chrystal proven gout in history&#xD;
&#xD;
          -  Patient is on uric acid lowering therapy (Allopurinol, Benzbromaron, Febuxostat)&#xD;
&#xD;
          -  Hip arthritis*&#xD;
&#xD;
          -  Metal or prosthesis of the inflamed joint&#xD;
&#xD;
          -  Highly suspicion of infectious arthritis&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Contra indication of joint aspiration (skin infection, hemophilia)&#xD;
&#xD;
          -  No informed consent&#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>Ruth Klaasen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Meander Medical Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ruth Klaasen, MD, PhD</last_name>
    <phone>0031338505050</phone>
    <email>r.klaasen@meandermc.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mihaela Gamala, MD</last_name>
    <phone>0031338505050</phone>
    <email>m.gamala@umcutrecht.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Meander Medical Center</name>
      <address>
        <city>Amersfoort</city>
        <state>Utrecht</state>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ruth Klaasen, MD, PhD</last_name>
      <phone>0031338505050</phone>
      <email>r.klaasen@menadermc.nl</email>
    </contact>
    <contact_backup>
      <last_name>Mihaela Gamala, MD</last_name>
      <phone_ext>0031338505050</phone_ext>
      <email>m.gamala@umcutrecht.nl</email>
    </contact_backup>
    <investigator>
      <last_name>Ruth Klaasen, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mihaela Gamala, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>September 17, 2016</study_first_submitted>
  <study_first_submitted_qc>January 28, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>March 17, 2019</last_update_submitted>
  <last_update_submitted_qc>March 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 19, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Meander Medical Center</investigator_affiliation>
    <investigator_full_name>Mihaela Gamala</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03038386
org study id: NL54454.100.15
nct id: NCT03038386
lead sponsor: 
has dmc: Yes
Rationale: Gout is a disease with growing incidence and complexity due to increased life
      expectancy, co-morbidity and medication. The disease can be diagnosed by microscopy,
      demonstrating monosodium uric acid (MSU) in synovial fluid of the affected joint or in tophi
      (subcutaneous or peritendinous MSU depositions). In daily practice, however, the diagnosis is
      difficult to ascertain due to sampling error (no synovial fluid acquired because the needle
      was not exactly placed in the affected joint, or the location of the gout might have been
      extra-articular e.g. around tendons) or to a different cause of acute arthritis (e.g.
      infection, reactive arthritis). Recently, Dual Energy CT scan has become available. This
      technique allows the visualization and quantification of MSU. Although imaging modalities
      such as DECT show promise in the classification of gout, the studies to date have been small
      and have primarily involved people with established disease.

      A study with cross-sectional design in which patients for whom the clinical questions "does
      this patient have gout?" are referred for participation may contribute to assess the value of
      DECT scan in diagnosing acute arthritis caused by gout.

      Objective: Assessment of value of DECT scan in diagnosing acute arthritis, caused by gout.

      Study design: Prospective Study population: Patients with acute mono or oligo arthritis
      without prior diagnosis, the rheumatologist has an indication for diagnostic needle
      aspiration.

      Nature and extent of the burden and risks associated with participation, benefit and group
      relatedness: In current daily practice, patients with acute mono- or oligo-arthritis without
      prior diagnosis undergo a diagnostic aspiration of the affected joint. This can be done by
      blind aspiration or ultra sound guided aspiration depending on the judgement of the
      rheumatologist. The aspirated synovial fluid is then assessed by polarized microscopy to
      detect MSU crystals. The diagnostic value of DECT in acute gout attacks had not yet been
      established and is therefore not used in daily practice. In this study all patients undergo
      DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If
      the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained
      prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound
      guided aspiration will take place, with knowledge of DECT results, followed by repeat
      microscopy
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The sensitivity and specificity (95% CI) of DECT scanning for the detection of MSU deposits
time frame: 2 weeks
measure: clinical and laboratory predicators of positive DECT scan in patients with acute mono or oligo arthritis
time frame: 2 weeks
measure: number of participants, in whom the first aspirate demonstrated no MSU and/or no synovial fluid, with MSU demonstrated after ultrasound guided joint aspiration
time frame: 2 weeks
measure: number of participants with positive DECT lesions, in whom the first aspirate(s) demonstrated no MSU and/or no synovial fluid with MSU demonstrated after ultrasound guided joint aspiration at the place of positive DECT lesion
time frame: 2 weeks
measure: cost of the gout diagnostic strategies (blind joint aspiration, ultrasound guided joint aspiration, DECT) will be calculated
time frame: 2 weeks
measure: Patient satisfaction: What does the patient experience as the most patient-friendly way of diagnosing gout: DECT scan, ultrasound-guided joint aspiration or blind aspiration?
time frame: 2 weeks
description: VAS DECT, blind joint aspiration, ultrasound guided joint aspiration
measure: correlation between cardiovascular risk and the urate volume on DECT
time frame: 2 weeks
description: correlation coefficient between cardiovascular risk (SCORE European and ACC/AHA) and the urate volume on DECT
measure: number of patients with clinical diagnosis gout 6 and 12 month after het DECT
time frame: 6 and 12 month
measure: number of patients on urate lowering medication 6 and 12 month after the DECT
time frame: 6 and 12 month
arm group label: Dual Energy CT
arm group type: Other
description: In this study all patients undergo DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound guided aspiration will take place, with knowledge of DECT results, followed by repeat microscopy
intervention type: Other
intervention name: Dual Energy CT
description: In this study all patients undergo DECT scan to assess the value of DECT scan in diagnosing acute arthritis caused by gout. If the DECT scan demonstrates MSU depositions and the diagnosis of gout was not ascertained prior to DECT scanning by MSU crystals in the synovial fluid, then additional ultrasound guided aspiration will take place, with knowledge of DECT results, followed by repeat microscopy
arm group label: Dual Energy CT
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ruth Klaasen, MD, PhD
role: Principal Investigator
affiliation: Meander Medical Center
last name: Ruth Klaasen, MD, PhD
phone: 0031338505050
email: r.klaasen@meandermc.nl
last name: Mihaela Gamala, MD
phone: 0031338505050
email: m.gamala@umcutrecht.nl
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Meander Medical Center
investigator full name: Mihaela Gamala
investigator title: MD
sharing ipd: Undecided