<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/NCT03038568</url>
  </required_header>
  <id_info>
    <org_study_id>17-010</org_study_id>
    <nct_id>NCT03038568</nct_id>
  </id_info>
  <brief_title>Assessing How Normal Variations in CT Scanning Affects Its Interpretation</brief_title>
  <official_title>Stability of Radiomic Features for Abdominal Tumors on Contrast Enhanced CT</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Memorial Sloan Kettering Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Queen's University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Memorial Sloan Kettering Cancer Center</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>
      The purpose of the study is to see how measurements of tumor differences vary with slight&#xD;
      changes in CT scan parameters. Reproducible radiomic features can be extracted for abdominal&#xD;
      tumors, and specifically colorectal liver metastases, imaged with clinical CT scanners even&#xD;
      in the setting of variable scan parameters and variable contrast timing. Participants will be&#xD;
      consented to undergo an additional CT of their abdomen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 27, 2017</start_date>
  <completion_date type="Anticipated">January 27, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 27, 2024</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>assess the stability (reproducibility) of radiomic measurements obtained from repeat abdominal CT scans</measure>
    <time_frame>2 years</time_frame>
    <description>There will be 18 cohorts, each cohort differing by the length of the time gap in acquisition and noise index. In addition each acquisition will be reconstructed in 21 different ways (combinations of 3 slice thicknesses and 7 ASiR levels).</description>
  </primary_outcome>
  <number_of_groups>18</number_of_groups>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Colorectal Cancer Metastatic</condition>
  <arm_group>
    <arm_group_label>Cohort 1</arm_group_label>
    <description>-15 second time gap between routine abdominal CT and add on CT, Noise Index of 12</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 2</arm_group_label>
    <description>-15 second time gap between routine abdominal CT and add on CT, Noise Index of 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 3</arm_group_label>
    <description>-15 second time gap between routine abdominal CT and add on CT, Noise Index of 16</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 4</arm_group_label>
    <description>-10 second time gap between routine abdominal CT and add on CT, Noise index 12</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 5</arm_group_label>
    <description>-10 second time gap between routine abdominal CT and add on CT, Noise index 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 6</arm_group_label>
    <description>-10 second time gap between routine abdominal CT and add on CT, Noise index 16</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 7</arm_group_label>
    <description>- 5 second time gap between routine abdominal CT and add on CT, Noise index 12</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 8</arm_group_label>
    <description>- 5 second time gap between routine abdominal CT and add on CT, Noise index 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 9</arm_group_label>
    <description>- 5 second time gap between routine abdominal CT and add on CT, Noise index 16</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 10</arm_group_label>
    <description>+ 5 second time gap between routine abdominal CT and add on CT, Noise index 12</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 11</arm_group_label>
    <description>+ 5 second time gap between routine abdominal CT and add on CT, Noise index 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 12</arm_group_label>
    <description>+ 5 second time gap between routine abdominal CT and add on CT, Noise index 16</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 13</arm_group_label>
    <description>+ 10 second time gap between routine abdominal CT and add on CT, Noise index 12</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 14</arm_group_label>
    <description>+ 10 second time gap between routine abdominal CT and add on CT, Noise index 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 15</arm_group_label>
    <description>+ 10 second time gap between routine abdominal CT and add on CT, Noise index 16</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 16</arm_group_label>
    <description>+ 15 second time gap between routine abdominal CT and add on CT, Noise 12</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 17</arm_group_label>
    <description>+ 15 second time gap between routine abdominal CT and add on CT, Noise 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cohort 18</arm_group_label>
    <description>+ 15 second time gap between routine abdominal CT and add on CT, Noise 16</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>CT scan</intervention_name>
    <description>Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.</description>
    <arm_group_label>Cohort 1</arm_group_label>
    <arm_group_label>Cohort 10</arm_group_label>
    <arm_group_label>Cohort 11</arm_group_label>
    <arm_group_label>Cohort 12</arm_group_label>
    <arm_group_label>Cohort 13</arm_group_label>
    <arm_group_label>Cohort 14</arm_group_label>
    <arm_group_label>Cohort 15</arm_group_label>
    <arm_group_label>Cohort 16</arm_group_label>
    <arm_group_label>Cohort 17</arm_group_label>
    <arm_group_label>Cohort 18</arm_group_label>
    <arm_group_label>Cohort 2</arm_group_label>
    <arm_group_label>Cohort 3</arm_group_label>
    <arm_group_label>Cohort 4</arm_group_label>
    <arm_group_label>Cohort 5</arm_group_label>
    <arm_group_label>Cohort 6</arm_group_label>
    <arm_group_label>Cohort 7</arm_group_label>
    <arm_group_label>Cohort 8</arm_group_label>
    <arm_group_label>Cohort 9</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who undergo contrast enhanced CT scanning for colorectal liver metastases will be&#xD;
        consented for one additional CT abdomen phase during the same imaging session.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients ≥ 18 years of age on the day of signed informed consent&#xD;
&#xD;
          -  Patients scheduled and approved for contrast enhanced CT that includes imaging of the&#xD;
             abdomen and pelvis following the Department of Radiology standard of care protocol as&#xD;
             per local institutional guidelines&#xD;
&#xD;
          -  Patients with measurable colorectal liver metastases on prior imaging, with at least&#xD;
             one tumor greater than 2.0 cm in axial maximal diameter&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient who is pregnant and/or lactating&#xD;
&#xD;
          -  Patient scheduled for CT that includes the abdomen with a multiphasic contrast&#xD;
             enhanced protocol (e.g. Triple Phase or Quadruple Phase Liver CT)&#xD;
&#xD;
          -  Patient who require reduced intravenous contrast dose based on the Department of&#xD;
             Radiology contrast policy as per local institutional guidelines&#xD;
&#xD;
          -  Any other medical condition, including mental illness or substance abuse, deemed by&#xD;
             the Investigator to be likely to interfere with a patient's ability to sign informed&#xD;
             consent, cooperate and participate in the study, or follow up procedures&#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>Kinh Gian Richard Do, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Memorial Sloan Kettering Cancer Center</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kinh Gian Richard Do, MD, PhD</last_name>
    <phone>212-639-8591</phone>
    <email>dok@mskcc.org</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mithat Gonen, PhD</last_name>
    <phone>646-888-8238</phone>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Memorial Sloan Kettering Cancer Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kinh Gian Richard Do, MD, PhD</last_name>
      <phone>212-639-8591</phone>
    </contact>
    <contact_backup>
      <last_name>Mithat Gonen, PhD</last_name>
      <phone>646-888-8238</phone>
    </contact_backup>
    <investigator>
      <last_name>Kinh Gian Richard Do, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>MD Anderson Cancer Center, Texas (Data collection only)</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yun Shin Chun, MD</last_name>
      <phone>877-632-6789</phone>
    </contact>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>Canada</country>
  </removed_countries>
  <link>
    <url>http://www.mskcc.org/mskcc/html/44.cfm</url>
    <description>Memorial Sloan Kettering Cancer Center</description>
  </link>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 30, 2017</study_first_submitted>
  <study_first_submitted_qc>January 30, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 31, 2017</study_first_posted>
  <last_update_submitted>April 14, 2023</last_update_submitted>
  <last_update_submitted_qc>April 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>colorectal liver metastases</keyword>
  <keyword>CT scan</keyword>
  <keyword>17-010</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Colorectal Neoplasms</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/NCT03038568
org study id: 17-010
nct id: NCT03038568
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to see how measurements of tumor differences vary with slight
      changes in CT scan parameters. Reproducible radiomic features can be extracted for abdominal
      tumors, and specifically colorectal liver metastases, imaged with clinical CT scanners even
      in the setting of variable scan parameters and variable contrast timing. Participants will be
      consented to undergo an additional CT of their abdomen.
observational model: Cohort
time perspective: Prospective
measure: assess the stability (reproducibility) of radiomic measurements obtained from repeat abdominal CT scans
time frame: 2 years
description: There will be 18 cohorts, each cohort differing by the length of the time gap in acquisition and noise index. In addition each acquisition will be reconstructed in 21 different ways (combinations of 3 slice thicknesses and 7 ASiR levels).
arm group label: Cohort 1
description: -15 second time gap between routine abdominal CT and add on CT, Noise Index of 12
arm group label: Cohort 2
description: -15 second time gap between routine abdominal CT and add on CT, Noise Index of 14
arm group label: Cohort 3
description: -15 second time gap between routine abdominal CT and add on CT, Noise Index of 16
arm group label: Cohort 4
description: -10 second time gap between routine abdominal CT and add on CT, Noise index 12
arm group label: Cohort 5
description: -10 second time gap between routine abdominal CT and add on CT, Noise index 14
arm group label: Cohort 6
description: -10 second time gap between routine abdominal CT and add on CT, Noise index 16
arm group label: Cohort 7
description: - 5 second time gap between routine abdominal CT and add on CT, Noise index 12
arm group label: Cohort 8
description: - 5 second time gap between routine abdominal CT and add on CT, Noise index 14
arm group label: Cohort 9
description: - 5 second time gap between routine abdominal CT and add on CT, Noise index 16
arm group label: Cohort 10
description: + 5 second time gap between routine abdominal CT and add on CT, Noise index 12
arm group label: Cohort 11
description: + 5 second time gap between routine abdominal CT and add on CT, Noise index 14
arm group label: Cohort 12
description: + 5 second time gap between routine abdominal CT and add on CT, Noise index 16
arm group label: Cohort 13
description: + 10 second time gap between routine abdominal CT and add on CT, Noise index 12
arm group label: Cohort 14
description: + 10 second time gap between routine abdominal CT and add on CT, Noise index 14
arm group label: Cohort 15
description: + 10 second time gap between routine abdominal CT and add on CT, Noise index 16
arm group label: Cohort 16
description: + 15 second time gap between routine abdominal CT and add on CT, Noise 12
arm group label: Cohort 17
description: + 15 second time gap between routine abdominal CT and add on CT, Noise 14
arm group label: Cohort 18
description: + 15 second time gap between routine abdominal CT and add on CT, Noise 16
intervention type: Diagnostic Test
intervention name: CT scan
description: Patients with colorectal liver metastases scheduled for abdominopelvic CECT will be consented to undergo an additional CT of their abdomen (termed add-on CT) within 15 seconds, before or after, their clinical portal venous phase CT (PV CT), which is performed at a fixed delay of 80 seconds at our institution.
arm group label: Cohort 1
arm group label: Cohort 10
arm group label: Cohort 11
arm group label: Cohort 12
arm group label: Cohort 13
arm group label: Cohort 14
arm group label: Cohort 15
arm group label: Cohort 16
arm group label: Cohort 17
arm group label: Cohort 18
arm group label: Cohort 2
arm group label: Cohort 3
arm group label: Cohort 4
arm group label: Cohort 5
arm group label: Cohort 6
arm group label: Cohort 7
arm group label: Cohort 8
arm group label: Cohort 9
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kinh Gian Richard Do, MD, PhD
role: Principal Investigator
affiliation: Memorial Sloan Kettering Cancer Center
last name: Kinh Gian Richard Do, MD, PhD
phone: 212-639-8591
email: dok@mskcc.org
last name: Mithat Gonen, PhD
phone: 646-888-8238
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
facility: 
status: Recruiting
contact: 
country: United States
country: Canada
url: http://www.mskcc.org/mskcc/html/44.cfm
description: Memorial Sloan Kettering Cancer Center
responsible party type: Sponsor
mesh term: Colorectal Neoplasms