xml: <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/NCT06024837</url>
    </required_header>
    <id_info>
      <org_study_id>IRBN1162022/CHUSTE</org_study_id>
      <nct_id>NCT06024837</nct_id>
    </id_info>
    <brief_title>Performance of Spectral CT-scan in Patients With Metastatic Colorectal Cancer: a Prospective Multicentre Study</brief_title>
    <official_title>Performance of Spectral CT-scan in Patients With Metastatic Colorectal Cancer: a Prospective Multicentre Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Universitaire de Saint Etienne</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>
        Spectral CT is a rapidly expanding imaging modality that allows a reduction in iodine dose&#xD;
        and irradiation compared to conventional scanning. It uses the difference in attenuation of&#xD;
        the material according to the two different energy levels of the incident x-ray beams. The&#xD;
        dual-energy scanner has a wide range of clinical applications, particularly in abdominal&#xD;
        imaging.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        First of all, the virtual creation of mono-energy images between 40 and 140 keV has shown&#xD;
        subjective and objective improvement of tumor detection of hypovascular lesions using low&#xD;
        energies (40keV). It has been shown to be of interest in vascular and cardiac imaging, and to&#xD;
        reduce artefacts in bone imaging. However, its performance in oncology analysis has been&#xD;
        little studied. The selection of patients for peritoneal and hepatic carcinosis surgery is&#xD;
        fundamental, as surgery allows a prolongation of survival, but are associated with a&#xD;
        non-negligible morbi-mortality rate.&#xD;
  &#xD;
        Spectral CT provides improved detection of peritoneal carcinosis and liver metastases of&#xD;
        colorectal cancer compared to conventional CT acquisition.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">June 7, 2023</start_date>
    <completion_date type="Anticipated">June 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Comparison of peritoneal and hepatic lesion mapping between spectral scanning and conventional scanning</measure>
      <time_frame>1 year</time_frame>
      <description>Comparison of peritoneal and hepatic lesion mapping between spectral scanning (monoenergetic acquisitions, iodine mapping, etc.) and conventional scanning (acquisition obtained during spectral acquisition).</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Comparison of evaluation of response to chemotherapy (if indicated) in RECIST 1.1 and Radiomics</measure>
      <time_frame>1 year</time_frame>
      <description>Collection of demographic, biological and surgical data.</description>
    </secondary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">100</enrollment>
    <condition>Colo-rectal Cancer</condition>
    <arm_group>
      <arm_group_label>Patients with Colo-rectal Cancer</arm_group_label>
      <description>Patients with Colo-rectal Cancer will be included.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>CT Images</intervention_name>
      <description>Analysis of CT images of peritoneal and/or liver metastases from colorectal cancer</description>
      <arm_group_label>Patients with Colo-rectal Cancer</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Patients with synchronous or metachronous peritoneal and/or liver metastases of colorectal&#xD;
          cancer with curative surgical plans.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients followed for colorectal cancer with synchronous or metachronous liver&#xD;
               metastases and/or peritoneal carcinosis&#xD;
  &#xD;
            -  Patients with a curative surgical resection plan&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients with non-metastatic colorectal cancer&#xD;
  &#xD;
            -  Patients treated with chemotherapy without surgical plans&#xD;
  &#xD;
            -  Patients with colorectal cancer with extra-hepatic and extra-peritoneal metastases&#xD;
               alone (e.g. lung, bone)&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rémi GRANGE, MD</last_name>
      <role>Principal Investigator</role>
      <affiliation>CHU Saint Etienne</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rémi GRANGE, MD</last_name>
      <phone>(0)477828963</phone>
      <phone_ext>+33</phone_ext>
      <email>remi.grange@chu-st-etienne.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Sylvain GRANGE, MD</last_name>
      <phone>(0)477829066</phone>
      <phone_ext>+33</phone_ext>
      <email>sylvain.grange@chu-st-etienne.fr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>CHU Saint-Etienne</name>
        <address>
          <city>Saint-Étienne</city>
          <zip>42000</zip>
          <country>France</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Rémi GRANGE, MD</last_name>
        <phone>(0)477828963</phone>
        <phone_ext>+33</phone_ext>
        <email>remi.grange@chu-st-etienne.fr</email>
      </contact>
      <contact_backup>
        <last_name>Sylvain GRANGE, MD</last_name>
        <phone>(0)477829066</phone>
        <phone_ext>+33</phone_ext>
        <email>sylvain.grange@chu-st-etienne.fr</email>
      </contact_backup>
      <investigator>
        <last_name>Rémi Grange, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Sylvain Grange, MD</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 29, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>August 29, 2023</last_update_submitted>
    <last_update_submitted_qc>August 29, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Colo-rectal cancer</keyword>
    <keyword>spectral CT scan</keyword>
    <keyword>liver metastases</keyword>
    <keyword>peritoneal carcinosis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Rectal Neoplasms</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06024837
  org study id: IRBN1162022/CHUSTE
  nct id: NCT06024837
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Spectral CT is a rapidly expanding imaging modality that allows a reduction in iodine dose
        and irradiation compared to conventional scanning. It uses the difference in attenuation of
        the material according to the two different energy levels of the incident x-ray beams. The
        dual-energy scanner has a wide range of clinical applications, particularly in abdominal
        imaging.
  First of all, the virtual creation of mono-energy images between 40 and 140 keV has shown
        subjective and objective improvement of tumor detection of hypovascular lesions using low
        energies (40keV). It has been shown to be of interest in vascular and cardiac imaging, and to
        reduce artefacts in bone imaging. However, its performance in oncology analysis has been
        little studied. The selection of patients for peritoneal and hepatic carcinosis surgery is
        fundamental, as surgery allows a prolongation of survival, but are associated with a
        non-negligible morbi-mortality rate.
  
        Spectral CT provides improved detection of peritoneal carcinosis and liver metastases of
        colorectal cancer compared to conventional CT acquisition.
  observational model: Cohort
  time perspective: Prospective
  measure: Comparison of peritoneal and hepatic lesion mapping between spectral scanning and conventional scanning
  time frame: 1 year
  description: Comparison of peritoneal and hepatic lesion mapping between spectral scanning (monoenergetic acquisitions, iodine mapping, etc.) and conventional scanning (acquisition obtained during spectral acquisition).
  measure: Comparison of evaluation of response to chemotherapy (if indicated) in RECIST 1.1 and Radiomics
  time frame: 1 year
  description: Collection of demographic, biological and surgical data.
  arm group label: Patients with Colo-rectal Cancer
  description: Patients with Colo-rectal Cancer will be included.
  intervention type: Other
  intervention name: CT Images
  description: Analysis of CT images of peritoneal and/or liver metastases from colorectal cancer
  arm group label: Patients with Colo-rectal Cancer
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: No
  last name: Rémi GRANGE, MD
  role: Principal Investigator
  affiliation: CHU Saint Etienne
  last name: Rémi GRANGE, MD
  phone: (0)477828963
  phone ext: +33
  email: remi.grange@chu-st-etienne.fr
  last name: Sylvain GRANGE, MD
  phone: (0)477829066
  phone ext: +33
  email: sylvain.grange@chu-st-etienne.fr
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  country: France
  responsible party type: Sponsor
  mesh term: Rectal Neoplasms
  sharing ipd: No