<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/NCT02983760</url>
  </required_header>
  <id_info>
    <org_study_id>SPECTACULAR - RB 16.068</org_study_id>
    <nct_id>NCT02983760</nct_id>
  </id_info>
  <brief_title>Comparison of 3 Diagnostic Strategies of PE: Planar V/Q Scan, CTPA, and V/Q SPECT.</brief_title>
  <acronym>SPECTACULAR</acronym>
  <official_title>Comparison of 3 Diagnostic Strategies of Pulmonary Embolism : Planar Ventilation-perfusion Scintigraphy (Planar V/Q Scan), Computed Tomography Pulmonary Angiography (CTPA), and V/Q Single Photon Emission Computed Tomography (SPECT)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pulmonary embolism (PE) remains a diagnostic challenge. False negative testing exposes&#xD;
      patient to the risk of potentially fatal recurrence. False positive testing exposes patients&#xD;
      to potentially fatal unduly side effects of anticoagulants.&#xD;
&#xD;
      Current diagnostic strategies rely on the sequential use of pretest clinical probability,&#xD;
      Ddimer test, and chest imaging. Two chest imaging modalities have been validated for PE&#xD;
      diagnostic exclusion: Computed Tomography Pulmonary Angiography (CTPA) and planar V/Q scan.&#xD;
      Main limitations of planar V/Q are the high proportion of non-conclusive results, therefore&#xD;
      requiring additional testing and more complex diagnostic algorithms. Main limitations of CTPA&#xD;
      are its higher radiation dose and contraindications (renal failure).&#xD;
&#xD;
      In a randomized trial that compared strategies based on CTPA and on planar V/Q scan, a 30%&#xD;
      increase in the rate of PE diagnoses was found in the arm using CTPA, raising the hypothesis&#xD;
      of over-diagnosing and over-treating PE when using CTPA.&#xD;
&#xD;
      V/Q Single Photon Emission CT (SPECT) is a new method of scintigraphic acquisition that has&#xD;
      been reported to improve the diagnostic performances of the test, which could reduce the&#xD;
      number of non-conclusive tests and allow simplified diagnostic algorithms.&#xD;
&#xD;
      The investigators hypothesize that a strategy based on V/Q SPECT could be an alternative to&#xD;
      the two usual approaches responding rightly to the two mains issues and combining the&#xD;
      advantages of CTPA (simplified diagnostic approach) and planar V/Q (no overdiagnosis, lower&#xD;
      radiation exposure, no contraindication).&#xD;
&#xD;
      Although a recent survey showed that up to 70% of nuclear medicine centers perform SPECT&#xD;
      rather than planar imaging for diagnosing PE, a diagnostic management outcome study, in which&#xD;
      diagnostic decision would be made on the basis of a standardized algorithm based on the V/Q&#xD;
      SPECT is lacking. Such a study needs to be conducted to ensure that the safety of diagnostic&#xD;
      exclusion using a V/Q SPECT based strategy is non-inferior to that of previously validated&#xD;
      strategies, and to verify that the use of V/Q SPECT does not lead to over-diagnosis.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 10, 2017</start_date>
  <completion_date type="Anticipated">July 10, 2022</completion_date>
  <primary_completion_date type="Anticipated">July 10, 2022</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Thromboembolic events rate in a 3 month follow-up period in patients left untreated after a negative diagnostic strategy.</measure>
    <time_frame>3 months</time_frame>
    <description>Rate of symptomatic objectively confirmed thromboembolic events during the 3-month follow-up period in patients left untreated after a negative diagnostic work-up in V/Q SPECT-based strategy in comparison with planar V/Q-based strategy and CTPA-based strategy.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of PE diagnostic in each arm</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of patients deemed to have PE according to the strategy in each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of additionnal tests required in each arm</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of patients for whom additional tests are requested in each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major bleeding incidence in each arm</measure>
    <time_frame>3 months</time_frame>
    <description>Incidence of major bleeding episodes in each arm.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incidence and cause of death in each arm</measure>
    <time_frame>3 months</time_frame>
    <description>Incidence and cause of death in each arm</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">3672</enrollment>
  <condition>Pulmonary Embolism</condition>
  <arm_group>
    <arm_group_label>Planar V/Q-based strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTPA-based strategy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control arm</description>
  </arm_group>
  <arm_group>
    <arm_group_label>V/Q SPECT-based strategy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental arm</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Planar V/Q-based strategy</intervention_name>
    <description>Strategy based on planar pulmonary scintigraphy</description>
    <arm_group_label>Planar V/Q-based strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CTPA-based strategy</intervention_name>
    <description>Strategy based on pulmonary angiography</description>
    <arm_group_label>CTPA-based strategy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>V/Q SPECT-based strategy</intervention_name>
    <description>Strategy based on pulmonary tomoscintigraphy</description>
    <arm_group_label>V/Q SPECT-based strategy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Outpatients with a clinically suspected PE (defined as an acute onset of new or&#xD;
             worsening shortness of breath, chest pain, hemoptysis, presyncope, or syncope) without&#xD;
             another obvious apparent cause.&#xD;
&#xD;
          -  High pretest clinical probability of PE or a non-high pretest clinical probability but&#xD;
             a positive D-Dimer test.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age less than 18 years&#xD;
&#xD;
          -  Patients with already confirmed PE&#xD;
&#xD;
          -  Patients with a clinically suspected high-risk pulmonary embolism (hypotension or&#xD;
             shock)&#xD;
&#xD;
          -  Use of therapeutic doses of anticoagulants for more than 48 hours&#xD;
&#xD;
          -  Other indication for long-term use of anticoagulants&#xD;
&#xD;
          -  Contraindication to contrast media (including renal insufficiency with a creatinine&#xD;
             clearance lower than 30 ml/min)&#xD;
&#xD;
          -  Life expectancy less than 3 months&#xD;
&#xD;
          -  Unable/unwilling to give informed consent&#xD;
&#xD;
          -  Unlikely to comply with study follow-up&#xD;
&#xD;
          -  Ongoing pregnancy or breastfeeding&#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>Pierre-Yves Salaun</last_name>
    <role>Study Director</role>
    <affiliation>CHRU de Brest</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Pierre-Yves Salaun</last_name>
    <phone>0298223117</phone>
    <email>pierre-yves.salaun@chu-brest.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Grégoire Le Gal</last_name>
    <email>gregoire.legal@chu-brest.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Hopital Saint Esprit</name>
      <address>
        <city>Agen</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Albert Trinh-Duc</last_name>
      <phone>+33(0)553697093</phone>
      <email>albert.trinh-duc@wanadoo.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU d'ANGERS</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre-Marie ROY</last_name>
      <phone>0141353715</phone>
      <email>pmroy@chu-angers.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Pierre-Yves Salaun</last_name>
      <phone>0298223117</phone>
      <email>pierre-yves.salaun@chu-brest.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hôpital des Armées Clermont Tonnerre</name>
      <address>
        <city>Brest</city>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Nicolas Paleiron</last_name>
      <phone>+33 (0)2 98 43 73 01</phone>
      <email>nicolas.paleiron@free.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU Clermont Ferrand</name>
      <address>
        <city>Clermont-Ferrand</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CHU de Dijon</name>
      <address>
        <city>Dijon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>CH des Pays de Morlaix</name>
      <address>
        <city>Morlaix</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Roge Christophe</last_name>
      <phone>+33 (0)2 98 62 61 60</phone>
      <email>croge@ch-morlaix.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Hegp - Ap-Hp</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Olivier Sanchez</last_name>
      <phone>0156093461</phone>
      <email>olivier.sanchez@ap-hp.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU la Réunion</name>
      <address>
        <city>Saint-Denis</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Xavier COMBES</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Saint Etienne</name>
      <address>
        <city>Saint-Étienne</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent Bertoletti</last_name>
      <phone>+33(0)477127770</phone>
      <email>laurent.bertoletti@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>CH Toulon</name>
      <address>
        <city>Toulon</city>
        <country>France</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Geneva University Hospital</name>
      <address>
        <city>Genève</city>
        <zip>1205</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marc Righini</last_name>
      <phone>+41 (0)22 372 92 94</phone>
      <email>Marc.Righini@hcuge.ch</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>November 28, 2016</study_first_submitted>
  <study_first_submitted_qc>December 2, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 6, 2016</study_first_posted>
  <last_update_submitted>July 20, 2021</last_update_submitted>
  <last_update_submitted_qc>July 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pulmonary embolism</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Embolism</mesh_term>
    <mesh_term>Embolism</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/NCT02983760
org study id: SPECTACULAR - RB 16.068
nct id: NCT02983760
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Pulmonary embolism (PE) remains a diagnostic challenge. False negative testing exposes
      patient to the risk of potentially fatal recurrence. False positive testing exposes patients
      to potentially fatal unduly side effects of anticoagulants.

      Current diagnostic strategies rely on the sequential use of pretest clinical probability,
      Ddimer test, and chest imaging. Two chest imaging modalities have been validated for PE
      diagnostic exclusion: Computed Tomography Pulmonary Angiography (CTPA) and planar V/Q scan.
      Main limitations of planar V/Q are the high proportion of non-conclusive results, therefore
      requiring additional testing and more complex diagnostic algorithms. Main limitations of CTPA
      are its higher radiation dose and contraindications (renal failure).

      In a randomized trial that compared strategies based on CTPA and on planar V/Q scan, a 30%
      increase in the rate of PE diagnoses was found in the arm using CTPA, raising the hypothesis
      of over-diagnosing and over-treating PE when using CTPA.

      V/Q Single Photon Emission CT (SPECT) is a new method of scintigraphic acquisition that has
      been reported to improve the diagnostic performances of the test, which could reduce the
      number of non-conclusive tests and allow simplified diagnostic algorithms.

      The investigators hypothesize that a strategy based on V/Q SPECT could be an alternative to
      the two usual approaches responding rightly to the two mains issues and combining the
      advantages of CTPA (simplified diagnostic approach) and planar V/Q (no overdiagnosis, lower
      radiation exposure, no contraindication).

      Although a recent survey showed that up to 70% of nuclear medicine centers perform SPECT
      rather than planar imaging for diagnosing PE, a diagnostic management outcome study, in which
      diagnostic decision would be made on the basis of a standardized algorithm based on the V/Q
      SPECT is lacking. Such a study needs to be conducted to ensure that the safety of diagnostic
      exclusion using a V/Q SPECT based strategy is non-inferior to that of previously validated
      strategies, and to verify that the use of V/Q SPECT does not lead to over-diagnosis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Thromboembolic events rate in a 3 month follow-up period in patients left untreated after a negative diagnostic strategy.
time frame: 3 months
description: Rate of symptomatic objectively confirmed thromboembolic events during the 3-month follow-up period in patients left untreated after a negative diagnostic work-up in V/Q SPECT-based strategy in comparison with planar V/Q-based strategy and CTPA-based strategy.
measure: Proportion of PE diagnostic in each arm
time frame: 3 months
description: Proportion of patients deemed to have PE according to the strategy in each arm.
measure: Proportion of additionnal tests required in each arm
time frame: 3 months
description: Proportion of patients for whom additional tests are requested in each arm.
measure: Major bleeding incidence in each arm
time frame: 3 months
description: Incidence of major bleeding episodes in each arm.
measure: Incidence and cause of death in each arm
time frame: 3 months
description: Incidence and cause of death in each arm
arm group label: Planar V/Q-based strategy
arm group type: Active Comparator
description: Control arm
arm group label: CTPA-based strategy
arm group type: Active Comparator
description: Control arm
arm group label: V/Q SPECT-based strategy
arm group type: Experimental
description: Experimental arm
intervention type: Device
intervention name: Planar V/Q-based strategy
description: Strategy based on planar pulmonary scintigraphy
arm group label: Planar V/Q-based strategy
intervention type: Device
intervention name: CTPA-based strategy
description: Strategy based on pulmonary angiography
arm group label: CTPA-based strategy
intervention type: Device
intervention name: V/Q SPECT-based strategy
description: Strategy based on pulmonary tomoscintigraphy
arm group label: V/Q SPECT-based strategy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pierre-Yves Salaun
role: Study Director
affiliation: CHRU de Brest
last name: Pierre-Yves Salaun
phone: 0298223117
email: pierre-yves.salaun@chu-brest.fr
last name: Grégoire Le Gal
email: gregoire.legal@chu-brest.fr
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
contact: 
country: France
country: Switzerland
responsible party type: Sponsor
mesh term: Pulmonary Embolism
mesh term: Embolism