<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/NCT02973516</url>
  </required_header>
  <id_info>
    <org_study_id>GDX-44-008</org_study_id>
    <nct_id>NCT02973516</nct_id>
  </id_info>
  <brief_title>Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis</brief_title>
  <official_title>Proof of Concept Study Concerning Efficacy of P03277 MR Imaging in HCC Diagnosis, Phase IIa Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Guerbet</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Guerbet</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is an exploratory study aiming to collect data about diagnosis efficacy&#xD;
      (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with&#xD;
      suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC&#xD;
      confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology&#xD;
      analysis. The standard of reference for diagnosis will be given by the site according to&#xD;
      their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous&#xD;
      contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site&#xD;
      and/or the more recent AFP results available). 10 additional subjects will be included to&#xD;
      explore the diagnostic efficacy for HCC at half dose of P03277.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 2016</start_date>
  <completion_date type="Actual">April 4, 2019</completion_date>
  <primary_completion_date type="Actual">April 4, 2019</primary_completion_date>
  <phase>Phase 2</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>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic Value Evaluation for HCC</measure>
    <time_frame>One day procedure</time_frame>
    <description>Sensitivity and specificity of diagnosis obtained by gadopiclenol imaging versus standard of reference</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Chronic Liver Disease</condition>
  <condition>HepatoCellular Carcinoma</condition>
  <arm_group>
    <arm_group_label>P03277 triphasic imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>P03277 will be administered in order to acquire triphasic liver imaging</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>P03277 at 0.1 mmol/kg</intervention_name>
    <description>P03277 will be administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.</description>
    <arm_group_label>P03277 triphasic imaging</arm_group_label>
    <other_name>gadopiclenol at 0.1 mmol/kg</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>P03277 at 0.05 mmol/kg</intervention_name>
    <description>P03277 will be administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.</description>
    <arm_group_label>P03277 triphasic imaging</arm_group_label>
    <other_name>gadopiclenol at 0.05 mmol/kg</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject presenting with liver cirrhosis or chronic liver disease as shown by previous&#xD;
             liver biopsy or by combination of clinical, endoscopic, biological, ultrasound&#xD;
             parameters, and elastography&#xD;
&#xD;
          -  Subject presenting with 1 to a maximum of 3 untreated hepatic nodule(s) of less than&#xD;
             or equal to 3 cm (long axis) previously identified and/or characterized through&#xD;
             enhanced CT and/or MRI within a maximum of 21 days before P03277 imaging, confirmed&#xD;
             for HCC or not&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject presenting with hepatic nodule more than 3 cm in addition to nodule(s) less&#xD;
             than or equal to 3 cm&#xD;
&#xD;
          -  Subject already treated for HCC by surgery or thermal ablation for which the resection&#xD;
             or coagulation area is less than 2 cm from the new nodule(s)&#xD;
&#xD;
          -  Subject previously treated by transarterial chemoembolization&#xD;
&#xD;
          -  Subject with moderate or severe renal impairment (eGFR &lt; 60 mL/min/1.73 m2) based on&#xD;
             measurement done or available within the 7 days before P03277 administration and&#xD;
             assessed after any iodinated contrast agent administration, or with dialysis end stage&#xD;
             renal disease (ESRD)&#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>Clinical Project Manager</last_name>
    <role>Study Director</role>
    <affiliation>Guerbet</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Beaujon</name>
      <address>
        <city>Clichy</city>
        <zip>92118</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 25, 2016</study_first_posted>
  <results_first_submitted>September 9, 2021</results_first_submitted>
  <results_first_submitted_qc>September 9, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">October 6, 2021</results_first_posted>
  <disposition_first_submitted>July 27, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>July 29, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 3, 2020</disposition_first_posted>
  <last_update_submitted>October 6, 2021</last_update_submitted>
  <last_update_submitted_qc>October 6, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Liver Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>December 12, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT02973516/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 11, 2019</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/16/NCT02973516/SAP_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Among the 41 screened patients, one failed to meet randomization criteria and was screen failure. Therefore, 40 patients were included: 30 in Cohort 1 (0.1 mmol/kg) and 10 in Cohort 2 (0.05 mmol/kg),</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Cohort 1</title>
          <description>Gadopiclenol administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.</description>
        </group>
        <group group_id="P2">
          <title>Cohort 2</title>
          <description>Gadopiclenol administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="30"/>
                <participants group_id="P2" count="10"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Analysis was performed for the Full Analysis Set (FAS). One patient from cohort 1 was not included in the FAS for not presenting any nodule at the time of inclusion.</population>
      <group_list>
        <group group_id="B1">
          <title>Cohort 1</title>
          <description>Gadopiclenol administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.</description>
        </group>
        <group group_id="B2">
          <title>Cohort 2</title>
          <description>Gadopiclenol administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="29"/>
            <count group_id="B2" value="10"/>
            <count group_id="B3" value="39"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.1" spread="6.5"/>
                    <measurement group_id="B2" value="60.7" spread="15.4"/>
                    <measurement group_id="B3" value="61" spread="9.3"/>
                  </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="6"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="8"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Body Mass Index</title>
          <units>kg/m^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27.07" spread="6.08"/>
                    <measurement group_id="B2" value="27.98" spread="5.16"/>
                    <measurement group_id="B3" value="27.30" spread="5.80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Diagnostic Value Evaluation for HCC</title>
        <description>Sensitivity and specificity of diagnosis obtained by gadopiclenol imaging versus standard of reference</description>
        <time_frame>One day procedure</time_frame>
        <population>Analysis performed on the Full Analysis Set Nodules (FASN). A total of 56 suspected nodules were characterized: 43 from cohort 1 and 13 from cohort 2.</population>
        <group_list>
          <group group_id="O1">
            <title>Cohort 1</title>
            <description>Gadopiclenol administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.</description>
          </group>
          <group group_id="O2">
            <title>Cohort 2</title>
            <description>Gadopiclenol administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.</description>
          </group>
        </group_list>
        <measure>
          <title>Diagnostic Value Evaluation for HCC</title>
          <description>Sensitivity and specificity of diagnosis obtained by gadopiclenol imaging versus standard of reference</description>
          <population>Analysis performed on the Full Analysis Set Nodules (FASN). A total of 56 suspected nodules were characterized: 43 from cohort 1 and 13 from cohort 2.</population>
          <units>percent</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="29"/>
                <count group_id="O2" value="10"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Sensitivity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="62"/>
                    <measurement group_id="O2" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Specificity</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="86"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Accuracy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="74"/>
                    <measurement group_id="O2" value="92"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Positive predictive value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="81"/>
                    <measurement group_id="O2" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Negative predictive value</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="70"/>
                    <measurement group_id="O2" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse events were recorded from informed consent signature up to 13 weeks after gadopiclenol administration</time_frame>
      <desc>Post-injection adverse events are reported below.</desc>
      <group_list>
        <group group_id="E1">
          <title>Cohort 1</title>
          <description>Gadopiclenol administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.</description>
        </group>
        <group group_id="E2">
          <title>Cohort 2</title>
          <description>Gadopiclenol administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <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="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>gastric perforation</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>procedural complication</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="30"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_vocab>MedDRA 20.1</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="30"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Feeling hot</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection site coldness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection site haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
              <event>
                <sub_title>Injection site pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood pressure increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle tightness</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="30"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="10"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There IS 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>
    <limitations_and_caveats>This study is an exploratory study with limited number of patients included. The number of nodules in each cohort is considerably different, therefore limiting the possibility of comparison between the cohorts.&#xD;
Gadopiclenol owns very high relaxivity, which prolonged the wash-out at portal or delayed phases in some cases, further clinical investigation with larger number of patients is needed to study behavior of gadopiclenol in liver imaging.</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jing Hao, MD, Head of Global Medical Affairs and Clinical Development</name_or_title>
      <organization>Guerbet</organization>
      <phone>+33 (0) 1 45 91 50 00</phone>
      <email>jing.hao@guerbet.com</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/NCT02973516
org study id: GDX-44-008
nct id: NCT02973516
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
This study is an exploratory study aiming to collect data about diagnosis efficacy
      (sensitivity and specificity) of P03277 triphasic liver imaging for HCC in subjects with
      suspected small nodules and chronic liver disease. 30 subjects will be included, having HCC
      confirmed or not by previous enhanced CT and/or MRI and before any biopsy for histology
      analysis. The standard of reference for diagnosis will be given by the site according to
      their standard of care and adapted from EASL/EORTC diagnostic criteria (considering previous
      contrast enhanced imaging (CT and/or MRI) and/or biopsy specimen analysis given on-site
      and/or the more recent AFP results available). 10 additional subjects will be included to
      explore the diagnostic efficacy for HCC at half dose of P03277.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Diagnostic Value Evaluation for HCC
time frame: One day procedure
description: Sensitivity and specificity of diagnosis obtained by gadopiclenol imaging versus standard of reference
arm group label: P03277 triphasic imaging
arm group type: Experimental
description: P03277 will be administered in order to acquire triphasic liver imaging
intervention type: Drug
intervention name: P03277 at 0.1 mmol/kg
description: P03277 will be administered at 0.1 mmol/kg BW (corresponding to 0.2 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
arm group label: P03277 triphasic imaging
other name: gadopiclenol at 0.1 mmol/kg
intervention type: Drug
intervention name: P03277 at 0.05 mmol/kg
description: P03277 will be administered at 0.05 mmol/kg BW (corresponding to 0.1 mL/kg BW) by intravenous (IV) bolus injection at 2 mL/s rate without dilution, followed by a 0.9% saline flush.
arm group label: P03277 triphasic imaging
other name: gadopiclenol at 0.05 mmol/kg
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Project Manager
role: Study Director
affiliation: Guerbet
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Liver Diseases
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: This study is an exploratory study with limited number of patients included. The number of nodules in each cohort is considerably different, therefore limiting the possibility of comparison between the cohorts.
Gadopiclenol owns very high relaxivity, which prolonged the wash-out at portal or delayed phases in some cases, further clinical investigation with larger number of patients is needed to study behavior of gadopiclenol in liver imaging.
point of contact: 