<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/NCT04466787</url>
  </required_header>
  <id_info>
    <org_study_id>69HCL18_0412</org_study_id>
    <secondary_id>2018-A02696-49</secondary_id>
    <nct_id>NCT04466787</nct_id>
  </id_info>
  <brief_title>Comparison of Spectral Photon Counting CT (SPCCT) With Dual Energy CT (DECT) and Magnetic Resonance Imaging (MRI) for Plaque and Lumen Carotid Arteries Evaluation</brief_title>
  <acronym>CAPL</acronym>
  <official_title>Comparison of Spectral Photon Counting CT (SPCCT) With Dual Energy CT (DECT) and Magnetic Resonance Imaging (MRI) for Plaque and Lumen Carotid Arteries Evaluation.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hospices Civils de Lyon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hospices Civils de Lyon</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>
      In this study, the investigator propose to determine the efficiency of a new and more&#xD;
      sophisticated imaging prototype, the Spectral Photon Counting Computed Tomography (SPCCT), at&#xD;
      characterizing vulnerable plaques and luminal stenosis in Carotid Atherosclerosis patients&#xD;
      compared to DECT (Dual Energy CT) and MRI (Magnetic Resonance Imaging) which are used in&#xD;
      current practice&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">June 20, 2019</start_date>
  <completion_date type="Anticipated">June 2024</completion_date>
  <primary_completion_date type="Anticipated">May 2024</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>
    <masking_description>The images will be read without knowing the CT scan used</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Lipid Necrotic Core (LNC) in mm² identified with SPCCT</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of the height and thickness of surface of the plaque's components</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipid Necrotic Core (LNC) in mm² identified with DECT</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of the height and thickness of surface of the plaque's components</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipid Necrotic Core (LNC) in mm² identified with histology</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of the height and thickness of surface of the plaque's components</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intra Plaque Hemorrhage (IPH) in mm² identified with SPCCT</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of the height and thickness of surface of the plaque's components</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intra Plaque Hemorrhage (IPH) in mm² identified with DECT</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of the height and thickness of surface of the plaque's components</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intra Plaque Hemorrhage (IPH) identified with histology</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of the height and thickness of surface of the plaque's components</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fibrous Cap Ulceration (FCU) in mm² identified with SPCCT</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of the height and thickness of surface of the plaque's components</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fibrous Cap Ulceration (FCU) in mm² identified with DECT</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of the height and thickness of surface of the plaque's components</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fibrous Cap Ulceration (FCU) in mm² identified with histology</measure>
    <time_frame>1 month</time_frame>
    <description>measurement of the height and thickness of surface of the plaque's components</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of irregularities identified with SPCCT</measure>
    <time_frame>1 month</time_frame>
    <description>- Irregularities as defined by &lt; 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of irregularities identified with DECT</measure>
    <time_frame>1 month</time_frame>
    <description>- Irregularities as defined by &lt; 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of irregularities identified with MRI</measure>
    <time_frame>1 month</time_frame>
    <description>- Irregularities as defined by &lt; 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ulcerations identified with SPCCT</measure>
    <time_frame>1 month</time_frame>
    <description>- Ulceration as defined by &gt; 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ulcerations identified with DECT</measure>
    <time_frame>1 month</time_frame>
    <description>- Ulceration as defined by &gt; 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ulcerations identified with MRI</measure>
    <time_frame>1 month</time_frame>
    <description>- Ulceration as defined by &gt; 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessable vascular segments with lack of image artifacts</measure>
    <time_frame>1 month</time_frame>
    <description>It will be assessed by estimating the image quality on scale from 1 to 4 (1 = poor, 2 = moderate, 3 = good, and 4 = excellent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>radiation dose received during SPCCT</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>radiation dose received during DECT</measure>
    <time_frame>1 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance to SPCCT assessed by a tolerance survey</measure>
    <time_frame>1 month</time_frame>
    <description>1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance to DECT assessed by a tolerance survey</measure>
    <time_frame>1 month</time_frame>
    <description>1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Tolerance to MRI assessed by a tolerance survey</measure>
    <time_frame>1 month</time_frame>
    <description>1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Supra-Aortic Stenosis</condition>
  <arm_group>
    <arm_group_label>Spectral Photon Counting Computed Tomography (SPCCT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The randomized SPCCT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dual Energy CT (DECT)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The randomized DECT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Spectral Photon Counting Computed Tomography (SPCCT)</intervention_name>
    <description>The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients &lt; 80 kg and 1 mL/kg for patients &gt; 80 kg, with a maximum of 90 mL.&#xD;
The SPCCT scanner is a prototype spectral photon-counting computed tomography system derived from a modified clinical CT system with a field of View (FOV) of 168 mm in-plane, and a z-coverage of 2 mm.</description>
    <arm_group_label>Spectral Photon Counting Computed Tomography (SPCCT)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Dual Energy CT (DECT)</intervention_name>
    <description>The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients &lt; 80 kg and 1 mL/kg for patients &gt; 80 kg, with a maximum of 90 mL.&#xD;
DECT : IQon, Philips</description>
    <arm_group_label>Dual Energy CT (DECT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female subjects of any ethnic background, aged &gt; 18 years&#xD;
&#xD;
          -  Any of the following known or suspected supra-aortic arterial disease based on : Prior&#xD;
             stroke; Transient Ischemic Attack; Amaurosis Fugax; Referred for evaluation of any&#xD;
             supra-aortic vessel; Follow-up for a stent in a supra-aortic vessel; Prior imaging&#xD;
             ultrasounds study showing &gt; ou = 50 % stenosis of a supra-aortic vessel segment&#xD;
             (within 60 days before consent)&#xD;
&#xD;
          -  Patient undergoing surgery within one month of carotid plaque evaluation&#xD;
&#xD;
          -  Willingness and ability to follow directions and complete all study procedures&#xD;
             specified in the protocol&#xD;
&#xD;
          -  Pre-menopausal women only : Negative urinary pregnancy test on the day of imaging&#xD;
             before the administration of study drug&#xD;
&#xD;
          -  Patient has accepted to participate to the study and has signed the written consent&#xD;
&#xD;
          -  Patient is affiliated to social security&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication to MRI examinations (e.g. inability to hold breath, severe&#xD;
             arrhythmias, very low cardiac output, severe claustrophobia, metallic devices not&#xD;
             approved for MRI such as defibrillators, pacemaker, heart valve prostheses, cochlear&#xD;
             implants, neuro-stimulators, implanted automated injection device, intraocular&#xD;
             metallic foreign bodies, neurosurgical and vascular clips);&#xD;
&#xD;
          -  Contraindication to the use of iodine and gadolinium containing contrast media&#xD;
             (including subjects with suspicion for/or known to have NSF);- History of severe&#xD;
             allergic or anaphylactic reaction to any allergen including drugs and contrast agents&#xD;
             (as judged by the investigator, taking into account the intensity of the event);&#xD;
&#xD;
          -  Estimated Glomerular Filtration Rate (eGFR) value &lt; 30 mL/min/1.73 m2 derived from a&#xD;
             serum creatinine result within 1 month before the imaging;&#xD;
&#xD;
          -  Any subject on hemodialysis or peritoneal dialysis (Note: If there are multiple&#xD;
             creatinine values, the values obtained prior to and closest to the time of the&#xD;
             examination should be used);&#xD;
&#xD;
          -  Acute renal insufficiency of any intensity, either due to hepato-renal syndrome or&#xD;
             occurring in the per-operative liver transplantation period;&#xD;
&#xD;
          -  Known subject history of severe cardiovascular disease (e.g. acute myocardial&#xD;
             infarction [&lt; 14 days], unstable angina, congestive heart failure New York Heart&#xD;
             Association class IV) or known long QT syndrome;&#xD;
&#xD;
          -  Suspected clinical instability or unpredictability of the clinical course during the&#xD;
             study period (e.g. due to previous surgery);&#xD;
&#xD;
          -  Scheduled or potentially expected for the period between the SPCCT or DECT and MRI:&#xD;
             Any procedure that may alter the MRI or CT interpretation; Any interventional or&#xD;
             surgical procedure involving the supra-aortic vessels.&#xD;
&#xD;
          -  Pregnant or nursing (including pumping for storage and feeding); 11. Patient under&#xD;
             guardianship, curators or safeguard of justice.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Philippe DOUEK, Pr</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospices Civils de Lyon</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Philippe DOUEK, Pr</last_name>
    <phone>4 72 07 18 83</phone>
    <phone_ext>+33</phone_ext>
    <email>douek@creatis.insa-lyon.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Adeline MANSUY</last_name>
    <phone>4 72 11 51 70</phone>
    <phone_ext>+33</phone_ext>
    <email>adeline.mansuy@chu-lyon.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Louis Pradel cardiovascular Hospital</name>
      <address>
        <city>Bron</city>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Douek Philippe, Pr</last_name>
      <email>douek@creatis.insa-lyon.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>March 19, 2020</study_first_submitted>
  <study_first_submitted_qc>July 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>August 3, 2023</last_update_submitted>
  <last_update_submitted_qc>August 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>diagnostic</keyword>
  <keyword>carotid plaque</keyword>
  <keyword>SPCCT</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aortic Valve Stenosis</mesh_term>
    <mesh_term>Aortic Stenosis, Supravalvular</mesh_term>
  </condition_browse>
  <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/NCT04466787
org study id: 69HCL18_0412
secondary id: 2018-A02696-49
nct id: NCT04466787
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In this study, the investigator propose to determine the efficiency of a new and more
      sophisticated imaging prototype, the Spectral Photon Counting Computed Tomography (SPCCT), at
      characterizing vulnerable plaques and luminal stenosis in Carotid Atherosclerosis patients
      compared to DECT (Dual Energy CT) and MRI (Magnetic Resonance Imaging) which are used in
      current practice
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
masking description: The images will be read without knowing the CT scan used
measure: Lipid Necrotic Core (LNC) in mm² identified with SPCCT
time frame: 1 month
description: measurement of the height and thickness of surface of the plaque's components
measure: Lipid Necrotic Core (LNC) in mm² identified with DECT
time frame: 1 month
description: measurement of the height and thickness of surface of the plaque's components
measure: Lipid Necrotic Core (LNC) in mm² identified with histology
time frame: 1 month
description: measurement of the height and thickness of surface of the plaque's components
measure: Intra Plaque Hemorrhage (IPH) in mm² identified with SPCCT
time frame: 1 month
description: measurement of the height and thickness of surface of the plaque's components
measure: Intra Plaque Hemorrhage (IPH) in mm² identified with DECT
time frame: 1 month
description: measurement of the height and thickness of surface of the plaque's components
measure: Intra Plaque Hemorrhage (IPH) identified with histology
time frame: 1 month
description: measurement of the height and thickness of surface of the plaque's components
measure: Fibrous Cap Ulceration (FCU) in mm² identified with SPCCT
time frame: 1 month
description: measurement of the height and thickness of surface of the plaque's components
measure: Fibrous Cap Ulceration (FCU) in mm² identified with DECT
time frame: 1 month
description: measurement of the height and thickness of surface of the plaque's components
measure: Fibrous Cap Ulceration (FCU) in mm² identified with histology
time frame: 1 month
description: measurement of the height and thickness of surface of the plaque's components
measure: Number of irregularities identified with SPCCT
time frame: 1 month
description: - Irregularities as defined by < 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
measure: Number of irregularities identified with DECT
time frame: 1 month
description: - Irregularities as defined by < 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
measure: Number of irregularities identified with MRI
time frame: 1 month
description: - Irregularities as defined by < 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
measure: Number of ulcerations identified with SPCCT
time frame: 1 month
description: - Ulceration as defined by > 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
measure: Number of ulcerations identified with DECT
time frame: 1 month
description: - Ulceration as defined by > 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
measure: Number of ulcerations identified with MRI
time frame: 1 month
description: - Ulceration as defined by > 2 mm indentation, fissure, or erosion on the luminal surface of a plaque, exposing a portion of the inner plaque to direct contact with circulating blood.
measure: Assessable vascular segments with lack of image artifacts
time frame: 1 month
description: It will be assessed by estimating the image quality on scale from 1 to 4 (1 = poor, 2 = moderate, 3 = good, and 4 = excellent)
measure: radiation dose received during SPCCT
time frame: 1 month
measure: radiation dose received during DECT
time frame: 1 month
measure: Tolerance to SPCCT assessed by a tolerance survey
time frame: 1 month
description: 1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004
measure: Tolerance to DECT assessed by a tolerance survey
time frame: 1 month
description: 1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004
measure: Tolerance to MRI assessed by a tolerance survey
time frame: 1 month
description: 1 to 10, 1= very bad, 10= very good. Survey adapted from Sparrow et al., Journal of magnetic resonance imaging 19:410-416, 2004
arm group label: Spectral Photon Counting Computed Tomography (SPCCT)
arm group type: Experimental
description: The randomized SPCCT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis
arm group label: Dual Energy CT (DECT)
arm group type: Active Comparator
description: The randomized DECT patient will have this CT scan and an MRI before surgery. The plaque carotid will be collected for histological analysis
intervention type: Diagnostic Test
intervention name: Spectral Photon Counting Computed Tomography (SPCCT)
description: The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients < 80 kg and 1 mL/kg for patients > 80 kg, with a maximum of 90 mL.
The SPCCT scanner is a prototype spectral photon-counting computed tomography system derived from a modified clinical CT system with a field of View (FOV) of 168 mm in-plane, and a z-coverage of 2 mm.
arm group label: Spectral Photon Counting Computed Tomography (SPCCT)
intervention type: Diagnostic Test
intervention name: Dual Energy CT (DECT)
description: The acquisition for the assessment of the brain parenchyma and for the evaluation of the cervical and intracranial arteries will be performed without and with iodine based contrast media, respectively. The same parameters will be used for both conditions but for a large volume, from the aortic arch to the top of the head. The iodinate contrast agent's injection (Iomeron 400, Bracco Imaging France) will be performed at 5mL/s into an 18G catheter, followed by a 20 mL saline flush that will be injected at the same rate. The bolus volume will be determined according to the patient's body weight : 70 mL for patients < 80 kg and 1 mL/kg for patients > 80 kg, with a maximum of 90 mL.
DECT : IQon, Philips
arm group label: Dual Energy CT (DECT)
criteria: 
gender: All
gender based: Yes
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Philippe DOUEK, Pr
role: Principal Investigator
affiliation: Hospices Civils de Lyon
last name: Philippe DOUEK, Pr
phone: 4 72 07 18 83
phone ext: +33
email: douek@creatis.insa-lyon.fr
last name: Adeline MANSUY
phone: 4 72 11 51 70
phone ext: +33
email: adeline.mansuy@chu-lyon.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Aortic Valve Stenosis
mesh term: Aortic Stenosis, Supravalvular
sharing ipd: Undecided