<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/NCT04430127</url>
  </required_header>
  <id_info>
    <org_study_id>2020-00052</org_study_id>
    <nct_id>NCT04430127</nct_id>
  </id_info>
  <brief_title>The Role of Quantitative Measures on Dual-energy CT in the Prediction of Colorectal Adenocarcinoma</brief_title>
  <official_title>The Role of Quantitative Measures on Dual-energy CT in the Prediction of Colorectal Adenocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Fribourgeois</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Fribourgeois</source>
  <oversight_info>
    <has_dmc>Yes</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>
      To demonstrate the potential role of dual-energy computed tomography (DECT) by iodine maps&#xD;
      data, aimed at discriminating colon cancer from colon wall pseudo-thickening.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Prospectively, 50 consecutive patients with pathology-proved colorectal tumor (detected by&#xD;
      optical colonoscopy) who undergo routine thoraco-abdominal DECT for initial staging in the&#xD;
      Department of Radiology at our institution from April 2020, will be included. The exclusion&#xD;
      criteria are as follows: patients with body mass index (BMI) above 30 kg/m2, patients with&#xD;
      renal insufficiency (estimated glomerular filtration rate &lt; 30 ml/min), allergy to iodinated&#xD;
      contrast and a known history of previous abdominal radiotherapy.&#xD;
&#xD;
      All patients will undergo a staging enhanced thoraco-abdominal CT by 256-slices CTs&#xD;
      (Revolution CT, GE healthcare) at Fribourg hospital. DECTs will be acquired without an enema,&#xD;
      rectal insufflation or oral contrast to have collapsed colorectal wall for further&#xD;
      measurements and to simulate routine clinical practice. No additional screening procedures,&#xD;
      such as a laboratory or diagnostic tests are necessary for the present study.&#xD;
&#xD;
      Upon acquiring 50 patients, CT quantitative assessments will be performed. Initially, data&#xD;
      will be transferred to AW Advantage workstations (GE Healthcare). Thereafter, for each&#xD;
      patient, the iodine map images will be created by post-processing by. All CT quantitative&#xD;
      measurements will be performed independently by two radiologists. Three regions of interest&#xD;
      (ROI) will be applied to colorectal tumor and the normal collapsed colorectal wall (confirmed&#xD;
      previously by colonoscopy) and consequently, the mean of these measurements will be reported.&#xD;
      These measurements correspond to mean iodine uptake of colorectal tumor and normal collapsed&#xD;
      wall, respectively. Finally, the iodine uptake of the tumoral lesion and normal collapsed&#xD;
      wall in each patient will be compared to demonstrate the significant difference in iodine&#xD;
      uptake. Investigators anticipate that the obtained cut-off value will be a new benchmark in&#xD;
      clinical practice, to exclude the colorectal tumors on non-prepared collapsed colon wall and&#xD;
      eliminate the need for a complementary colonoscopy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 1, 2020</start_date>
  <completion_date type="Anticipated">December 31, 2022</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2022</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference of iodine uptake</measure>
    <time_frame>3.11.2021</time_frame>
    <description>Difference of iodine uptake between colorectal tumor and pseudo-thickened colorectal wall on DECT</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Colorectal Adenocarcinoma</condition>
  <arm_group>
    <arm_group_label>Colorectal adenocarcinoma</arm_group_label>
    <description>patients with pathology-proved colorectal tumor (detected by optical colonoscopy) who undergo routine thoraco-abdominal DECT for initial staging</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No supplementary intervention is performed</intervention_name>
    <description>No supplementary intervention will be applied</description>
    <arm_group_label>Colorectal adenocarcinoma</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with pathology-proved colorectal tumor (detected by optical colonoscopy) who&#xD;
        undergo routine thoraco-abdominal DECT for initial staging in the Department of Radiology&#xD;
        at our institution from April 2020&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        . pathology-proved colorectal tumor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  BMI above 30 kg/m2&#xD;
&#xD;
          -  renal insufficiency (estimated glomerular filtration rate &lt; 30 ml/min),&#xD;
&#xD;
          -  allergy to iodinated contrast, and a&#xD;
&#xD;
          -  known history of previous abdominal radiotherapy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Sonaz Malekzadeh</name>
      <address>
        <city>Fribourg</city>
        <zip>1708</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sonaz Malekzadeh, MD</last_name>
      <phone>+41783012848</phone>
      <email>soonazmalakzadeh@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 10, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>August 2, 2022</last_update_submitted>
  <last_update_submitted_qc>August 2, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 4, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Fribourgeois</investigator_affiliation>
    <investigator_full_name>Malekzadeh</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adenocarcinoma</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04430127
org study id: 2020-00052
nct id: NCT04430127
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
To demonstrate the potential role of dual-energy computed tomography (DECT) by iodine maps
      data, aimed at discriminating colon cancer from colon wall pseudo-thickening.
Prospectively, 50 consecutive patients with pathology-proved colorectal tumor (detected by
      optical colonoscopy) who undergo routine thoraco-abdominal DECT for initial staging in the
      Department of Radiology at our institution from April 2020, will be included. The exclusion
      criteria are as follows: patients with body mass index (BMI) above 30 kg/m2, patients with
      renal insufficiency (estimated glomerular filtration rate < 30 ml/min), allergy to iodinated
      contrast and a known history of previous abdominal radiotherapy.

      All patients will undergo a staging enhanced thoraco-abdominal CT by 256-slices CTs
      (Revolution CT, GE healthcare) at Fribourg hospital. DECTs will be acquired without an enema,
      rectal insufflation or oral contrast to have collapsed colorectal wall for further
      measurements and to simulate routine clinical practice. No additional screening procedures,
      such as a laboratory or diagnostic tests are necessary for the present study.

      Upon acquiring 50 patients, CT quantitative assessments will be performed. Initially, data
      will be transferred to AW Advantage workstations (GE Healthcare). Thereafter, for each
      patient, the iodine map images will be created by post-processing by. All CT quantitative
      measurements will be performed independently by two radiologists. Three regions of interest
      (ROI) will be applied to colorectal tumor and the normal collapsed colorectal wall (confirmed
      previously by colonoscopy) and consequently, the mean of these measurements will be reported.
      These measurements correspond to mean iodine uptake of colorectal tumor and normal collapsed
      wall, respectively. Finally, the iodine uptake of the tumoral lesion and normal collapsed
      wall in each patient will be compared to demonstrate the significant difference in iodine
      uptake. Investigators anticipate that the obtained cut-off value will be a new benchmark in
      clinical practice, to exclude the colorectal tumors on non-prepared collapsed colon wall and
      eliminate the need for a complementary colonoscopy.
observational model: Other
time perspective: Prospective
measure: Difference of iodine uptake
time frame: 3.11.2021
description: Difference of iodine uptake between colorectal tumor and pseudo-thickened colorectal wall on DECT
arm group label: Colorectal adenocarcinoma
description: patients with pathology-proved colorectal tumor (detected by optical colonoscopy) who undergo routine thoraco-abdominal DECT for initial staging
intervention type: Other
intervention name: No supplementary intervention is performed
description: No supplementary intervention will be applied
arm group label: Colorectal adenocarcinoma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 80 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Hôpital Fribourgeois
investigator full name: Malekzadeh
investigator title: Principal Investigator
mesh term: Adenocarcinoma
sharing ipd: No