<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/NCT01673802</url>
  </required_header>
  <id_info>
    <org_study_id>R11-153</org_study_id>
    <secondary_id>117354</secondary_id>
    <nct_id>NCT01673802</nct_id>
  </id_info>
  <brief_title>The Role of Gadoxetate (Eovist) Enhanced CT in Evaluating Cholangiocarcinoma</brief_title>
  <official_title>The Role of Gadoxetate Enhanced Spectral Dual-Energy CT in Evaluating Hilar Cholangiocarcinoma</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Society of Abdominal Radiology</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alabama at Birmingham</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this project is to evaluate the role of gadoxetate (Eovist®) enhanced&#xD;
      dual-energy CT in better evaluating perihilar cholangiocarcinoma. This pilot project aims to&#xD;
      address a long-term pitfall in the imaging of cholangiocarcinomas, by providing higher&#xD;
      resolution delineation of these often infiltrative tumors on single-source, Dual-Energy&#xD;
      Spectral Multi Detector CT (MDCT), capitalizing on improved spatial resolution achievable&#xD;
      with MDCT compared to MRI and at the same time producing a non-invasive CT cholangiogram to&#xD;
      aid in accurate diagnosis and treatment planning of cholangiocarcinoma, particularly, the&#xD;
      hilar variety.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of this project is to evaluate the role of gadoxetate (Eovist) enhanced&#xD;
      dual-energy CT in better evaluating perihilar cholangiocarcinoma, by exploiting the&#xD;
      combination of the physiologic behavior of gadoxetate in liver tissue combined with the&#xD;
      advantageous mass attenuation coefficient of Gadolinium achievable through dual energy&#xD;
      technique. This combination of unique CT imaging sensitivity, high resolution and&#xD;
      differential enhancement potentially allows improved visualization and detection of tumor&#xD;
      relative to enhancing surrounding hepatic parenchyma and ductal anatomy in the hepatobiliary&#xD;
      phase, due to the biliary excretion of the agent.&#xD;
&#xD;
      Cholangiocarcinoma is a hepatic adenocarcinoma that arises from the bile duct epithelium and&#xD;
      is the second most prevalent liver cancer after hepatocellular carcinoma. The hilar&#xD;
      intrahepatic variety of cholangiocarcinoma can present as an infiltrative, exophytic, or&#xD;
      polypoid lesion. Most extra-hepatic cholangiocarcinomas are infiltrative, causing a focal&#xD;
      stricture of the bile duct and result in proximal biliary ductal dilatation.&#xD;
&#xD;
      While magnetic resonance (MR) cholangiography is diagnostic in the majority of patients with&#xD;
      malignant hilar strictures, evaluation is limited by spatial resolution and in some patients,&#xD;
      the inability to have an MRI scan. Standard Multi Detector CT (MDCT) using iodinated contrast&#xD;
      agents, on the other hand, is limited in evaluation of cholangiocarcinomas, due to the lack&#xD;
      of consistent enhancement of the tumor with iodinated contrast.&#xD;
&#xD;
      Single-source, Dual-Energy (SSDE) Spectral MDCT utilizes a single fast switching x-ray beam&#xD;
      source to acquire near simultaneous data sets at two different photon energies during a&#xD;
      single acquisition. Data is acquired at 80 kilovolt peak (kVp) and 140 kVp with image&#xD;
      reconstruction achievable as a selectable monochromatic presentation over a range of 40 - 140&#xD;
      kiloelectron volt (keV), typically 70-78 keV for diagnostic image presentation. At lower tube&#xD;
      voltage, the frequency of photoelectric interactions increases exponentially and is strongly&#xD;
      dependent on the atomic number. Therefore, for substances with higher atomic number, such as&#xD;
      iodine and gadolinium the increased frequency of photoelectric and k-edge interactions at low&#xD;
      tube voltage substantially increases CT attenuation, thus improving contrast. Gadolinium is&#xD;
      further unique with k-edge attenuation at approximately 53 keV, within the available&#xD;
      monochromatic reconstruction range, thus allowing for significant greater detectability.&#xD;
      Additional material decomposition technique allows for unique material presentation and&#xD;
      analysis such as gadolinium/ water pair analysis with high spatial resolution.&#xD;
&#xD;
      Dual-Energy technology is limited by the types of contrast agents currently available, all&#xD;
      based on Iodine. Gadoxetate (Eovist) is a relatively new Gadolinium based MRI contrast agent&#xD;
      that is capable of producing not only standard appearing MRI images in the hepatic arterial&#xD;
      and portal venous phases, but also provides an opportunity to better visualize the bile ducts&#xD;
      and liver parenchyma as it is excreted by the liver into the biliary system during the&#xD;
      hepatobiliary phase.&#xD;
&#xD;
      This pilot project aims to address a long-term pitfall in the imaging of cholangiocarcinomas,&#xD;
      by providing higher resolution delineation of these often infiltrative tumors on&#xD;
      single-source, Dual-Energy Spectral MDCT, capitalizing on improved spatial resolution&#xD;
      achievable with MDCT compared to MRI and at the same time producing a non-invasive CT&#xD;
      cholangiogram to aid in accurate diagnosis and treatment planning of cholangiocarcinoma,&#xD;
      particularly, the hilar variety.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">January 2014</completion_date>
  <primary_completion_date type="Actual">January 2014</primary_completion_date>
  <phase>Early Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Single arm study, with dose adjustment.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT</measure>
    <time_frame>24 hrs</time_frame>
    <description>CT scans were assessed for tumor visualization after use of Gadoxetate disodium</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Cholangiocarcinoma</condition>
  <arm_group>
    <arm_group_label>CT imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CT scan</intervention_name>
    <description>Gadoxetate (Eovist) enhanced dual energy CT</description>
    <arm_group_label>CT imaging</arm_group_label>
    <other_name>Dual Energy CT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subjects will be adult (age 19 or older) with suspected cholangiocarcinoma of the&#xD;
             liver.&#xD;
&#xD;
          2. Subject must be able to provide a written informed consent.&#xD;
&#xD;
          3. Subject will be scheduled for gadoxetate contrast enhanced MRI scan of the liver&#xD;
             (obtained as part of usual clinical practice).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Standard MRI safety screening criteria will be employed, and subject will be excluded&#xD;
             if any contraindications to undergo MRI are met.&#xD;
&#xD;
          2. Subjects with metallic biliary stents or multiple peripancreatic surgical clips on&#xD;
             abdominal MDCT will be excluded.&#xD;
&#xD;
          3. Subjects on hemodialysis or with glomerular filtration rate (GFR) less than 30 will be&#xD;
             excluded.&#xD;
&#xD;
          4. Subjects will not be excluded on the basis of gender, race, ethnicity, or religion.&#xD;
&#xD;
          5. Subject may not be pregnant or lactating.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John V Thomas, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Alabama at Birmingham</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>August 13, 2012</study_first_submitted>
  <study_first_submitted_qc>August 23, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2012</study_first_posted>
  <results_first_submitted>May 20, 2014</results_first_submitted>
  <results_first_submitted_qc>May 20, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">June 20, 2014</results_first_posted>
  <last_update_submitted>April 12, 2017</last_update_submitted>
  <last_update_submitted_qc>April 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>John V. Thomas</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Cholangiocarcinoma</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Cholangiocarcinoma</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Gadoxetate Uptake in CT Imaging</title>
          <description>Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Gadoxetate Standard Dose 0.025 mmol/kg</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
        <period>
          <title>Gadoxetate Double Dose 0.050 mmol/kg</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Gadoxetate Uptake in CT Imaging</title>
          <description>Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="18"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Full Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="54.9" lower_limit="31" upper_limit="81"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT</title>
        <description>CT scans were assessed for tumor visualization after use of Gadoxetate disodium</description>
        <time_frame>24 hrs</time_frame>
        <population>Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT</population>
        <group_list>
          <group group_id="O1">
            <title>Gadoxetate Uptake in CT Imaging</title>
            <description>Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT</title>
          <description>CT scans were assessed for tumor visualization after use of Gadoxetate disodium</description>
          <population>Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT</population>
          <units>participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Baseline to 24 hours</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Gadoxetate Uptake in CT Imaging</title>
          <description>Patients will undergo a standard of care Gadoxetate (Eovist 0.025 mmol/kg) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast. After the first 8 subjects were accrued, it was apparent that the standard clinical dose was suboptimal for visualization on rsDECT. After obtaining additional regulatory approvals including an investigative New Drug (IND) letter from the FDA, as well as new approval from our institution's IRB, all subsequent subjects were scanned with 0.05 mmol/kg Gadoxetate Disodium. Both groups were injected with Gadoxetate Disodium at a rate of 1 ml/s.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="18"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>John V. Thomas, MD; Principal Investigator</name_or_title>
      <organization>University of Alabama at Bimringham</organization>
      <phone>205-996-4132</phone>
      <email>jvthomas@uabmc.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01673802
org study id: R11-153
secondary id: 117354
nct id: NCT01673802
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this project is to evaluate the role of gadoxetate (Eovist®) enhanced
      dual-energy CT in better evaluating perihilar cholangiocarcinoma. This pilot project aims to
      address a long-term pitfall in the imaging of cholangiocarcinomas, by providing higher
      resolution delineation of these often infiltrative tumors on single-source, Dual-Energy
      Spectral Multi Detector CT (MDCT), capitalizing on improved spatial resolution achievable
      with MDCT compared to MRI and at the same time producing a non-invasive CT cholangiogram to
      aid in accurate diagnosis and treatment planning of cholangiocarcinoma, particularly, the
      hilar variety.
The purpose of this project is to evaluate the role of gadoxetate (Eovist) enhanced
      dual-energy CT in better evaluating perihilar cholangiocarcinoma, by exploiting the
      combination of the physiologic behavior of gadoxetate in liver tissue combined with the
      advantageous mass attenuation coefficient of Gadolinium achievable through dual energy
      technique. This combination of unique CT imaging sensitivity, high resolution and
      differential enhancement potentially allows improved visualization and detection of tumor
      relative to enhancing surrounding hepatic parenchyma and ductal anatomy in the hepatobiliary
      phase, due to the biliary excretion of the agent.

      Cholangiocarcinoma is a hepatic adenocarcinoma that arises from the bile duct epithelium and
      is the second most prevalent liver cancer after hepatocellular carcinoma. The hilar
      intrahepatic variety of cholangiocarcinoma can present as an infiltrative, exophytic, or
      polypoid lesion. Most extra-hepatic cholangiocarcinomas are infiltrative, causing a focal
      stricture of the bile duct and result in proximal biliary ductal dilatation.

      While magnetic resonance (MR) cholangiography is diagnostic in the majority of patients with
      malignant hilar strictures, evaluation is limited by spatial resolution and in some patients,
      the inability to have an MRI scan. Standard Multi Detector CT (MDCT) using iodinated contrast
      agents, on the other hand, is limited in evaluation of cholangiocarcinomas, due to the lack
      of consistent enhancement of the tumor with iodinated contrast.

      Single-source, Dual-Energy (SSDE) Spectral MDCT utilizes a single fast switching x-ray beam
      source to acquire near simultaneous data sets at two different photon energies during a
      single acquisition. Data is acquired at 80 kilovolt peak (kVp) and 140 kVp with image
      reconstruction achievable as a selectable monochromatic presentation over a range of 40 - 140
      kiloelectron volt (keV), typically 70-78 keV for diagnostic image presentation. At lower tube
      voltage, the frequency of photoelectric interactions increases exponentially and is strongly
      dependent on the atomic number. Therefore, for substances with higher atomic number, such as
      iodine and gadolinium the increased frequency of photoelectric and k-edge interactions at low
      tube voltage substantially increases CT attenuation, thus improving contrast. Gadolinium is
      further unique with k-edge attenuation at approximately 53 keV, within the available
      monochromatic reconstruction range, thus allowing for significant greater detectability.
      Additional material decomposition technique allows for unique material presentation and
      analysis such as gadolinium/ water pair analysis with high spatial resolution.

      Dual-Energy technology is limited by the types of contrast agents currently available, all
      based on Iodine. Gadoxetate (Eovist) is a relatively new Gadolinium based MRI contrast agent
      that is capable of producing not only standard appearing MRI images in the hepatic arterial
      and portal venous phases, but also provides an opportunity to better visualize the bile ducts
      and liver parenchyma as it is excreted by the liver into the biliary system during the
      hepatobiliary phase.

      This pilot project aims to address a long-term pitfall in the imaging of cholangiocarcinomas,
      by providing higher resolution delineation of these often infiltrative tumors on
      single-source, Dual-Energy Spectral MDCT, capitalizing on improved spatial resolution
      achievable with MDCT compared to MRI and at the same time producing a non-invasive CT
      cholangiogram to aid in accurate diagnosis and treatment planning of cholangiocarcinoma,
      particularly, the hilar variety.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Single arm study, with dose adjustment.
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Subjects Where Hilar Cholangiocarcinomas Could be Visualized Using Gadoxetate Disodium Enhanced Dual Energy CT
time frame: 24 hrs
description: CT scans were assessed for tumor visualization after use of Gadoxetate disodium
arm group label: CT imaging
arm group type: Experimental
description: Patients will undergo a standard of care Gadoxetate (Eovist) MRI for cholangiocarcinoma. Patients will then be immediately placed on the CT scanner. Patients will undergo a dual energy CT of the abdomen with no additional contrast.
intervention type: Drug
intervention name: CT scan
description: Gadoxetate (Eovist) enhanced dual energy CT
arm group label: CT imaging
other name: Dual Energy CT
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: John V Thomas, MD
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: John V. Thomas
investigator title: Associate Professor
mesh term: Cholangiocarcinoma
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 