<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/NCT03262389</url>
  </required_header>
  <id_info>
    <org_study_id>16-007867</org_study_id>
    <nct_id>NCT03262389</nct_id>
  </id_info>
  <brief_title>Comparison of F-18 FDG and C-11 Acetate PET in Multiple Myeloma</brief_title>
  <official_title>Comparison of F-18 FDG PET CT and PET MRI With C-11 Acetate PET CT and PET MRI in the Diagnosis of Active Multiple Myeloma Disease: a Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Michael C Roarke, MD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</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>
      Investigators are doing this study to determine which of four imaging techniques:&#xD;
      Fludeoxyglucose Positron Emission Tomography (18 FDG PET) computerized tomography (CT), 18&#xD;
      FDG PET Magnetic resonance imaging (MRI), C-11 acetate PET CT, and C-11 acetate PET MRI) is&#xD;
      the best test for finding sites of active myeloma disease.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Participants who are clinically scheduled to undergo F-18 FDG PET/CT myeloma evaluation will&#xD;
      also undergo F-18 FDG PET/MRI, and C-11 acetate PET CT/MRI. On Day 1 of study, participants&#xD;
      will undergo F-18 FDG PET/CT-MRI. F-18 FDG radiopharmaceutical is infused intravenously,&#xD;
      followed by a 60 minute waiting uptake phase. After 60 minutes, participant will undergo&#xD;
      PET/CT imaging for 30 minutes. At 90 minutes, participant will undergo PET/MRI imaging for 30&#xD;
      minutes. On Day 2 of study, participants will undergo C-11 PET/CT-MRI. C-11&#xD;
      radiopharmaceutical is infused intravenously, followed by a 10 minute uptake phase. After 10&#xD;
      minutes, participant will undergo PET/CT imaging for 30 minutes, followed by a 60 minute&#xD;
      pause with the participant at rest. At the end of 60 minute pause, the participant is given&#xD;
      the second C-11 acetate infusion, followed by a 10 minute waiting uptake phase. After 10&#xD;
      minutes, participant will undergo PET/MRI imaging for 30 minutes. On Day 3, study team member&#xD;
      makes a phone call to participant for follow up.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 19, 2017</start_date>
  <completion_date type="Actual">November 23, 2019</completion_date>
  <primary_completion_date type="Actual">November 23, 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>Mean Multiple Myeloma Lesions Detected</measure>
    <time_frame>Day 1, Day 2</time_frame>
    <description>The number of lesions detected in the scans will be averaged for each technique. Two techniques (scans) will be tested on Day 1 and two techniques (scans) will be tested on Day 2.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Visual Image Analysis of Detected Multiple Myeloma Lesions</measure>
    <time_frame>Approximately one month after Day 2</time_frame>
    <description>The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>Multiple Myeloma Patients</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants will receive 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant will receive both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludeoxyglucose PET CT</intervention_name>
    <description>Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).</description>
    <arm_group_label>Multiple Myeloma Patients</arm_group_label>
    <other_name>F-18 FDG PET CT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Acetate C11 PET CT</intervention_name>
    <description>Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).</description>
    <arm_group_label>Multiple Myeloma Patients</arm_group_label>
    <other_name>C-11 acetate PET CT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Fludeoxyglucose PET MRI</intervention_name>
    <description>Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).</description>
    <arm_group_label>Multiple Myeloma Patients</arm_group_label>
    <other_name>F-18 FDG PET MRI</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Sodium Acetate C11 PET MRI</intervention_name>
    <description>Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).</description>
    <arm_group_label>Multiple Myeloma Patients</arm_group_label>
    <other_name>C11 PET MRI</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients being staged for multiple myeloma as follows: new diagnosis, high risk&#xD;
             smoldering multiple myeloma, relapsed as defined by investigator&#xD;
&#xD;
          -  Patients who have undergone standard of care workup&#xD;
&#xD;
          -  300 pounds or less&#xD;
&#xD;
          -  Can provide informed consent&#xD;
&#xD;
          -  Scheduled for a clinically indicated F-18 FDG PET scan&#xD;
&#xD;
          -  English speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant, breast feeding&#xD;
&#xD;
          -  Concurrent active non-multiple myeloma malignancy&#xD;
&#xD;
          -  Contraindication to PET MRI&#xD;
&#xD;
          -  Previous Type I or Type II Diabetes mellitus or a fasting blood glucose &gt;150 mg/dl&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Michael C Roarke</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Arizona</name>
      <address>
        <city>Scottsdale</city>
        <state>Arizona</state>
        <zip>85259</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>February 2021</verification_date>
  <study_first_submitted>August 22, 2017</study_first_submitted>
  <study_first_submitted_qc>August 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 25, 2017</study_first_posted>
  <results_first_submitted>February 22, 2021</results_first_submitted>
  <results_first_submitted_qc>February 22, 2021</results_first_submitted_qc>
  <results_first_posted type="Actual">March 16, 2021</results_first_posted>
  <disposition_first_submitted>August 18, 2020</disposition_first_submitted>
  <disposition_first_submitted_qc>August 18, 2020</disposition_first_submitted_qc>
  <disposition_first_posted type="Actual">August 25, 2020</disposition_first_posted>
  <last_update_submitted>February 22, 2021</last_update_submitted>
  <last_update_submitted_qc>February 22, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 16, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Michael C Roarke, MD</investigator_full_name>
    <investigator_title>Sponsor-Investigator</investigator_title>
  </responsible_party>
  <keyword>positron emission tomography (PET)</keyword>
  <keyword>computerized tomography (CT)</keyword>
  <keyword>Magnetic resonance imaging (MRI)</keyword>
  <keyword>Fludeoxyglucose (F-18 FDG)</keyword>
  <keyword>C-11 acetate</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Multiple Myeloma</mesh_term>
    <mesh_term>Neoplasms, Plasma Cell</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fluorodeoxyglucose F18</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>June 6, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/89/NCT03262389/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Multiple Myeloma (MM) Patients</title>
          <description>New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.&#xD;
Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).&#xD;
Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</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="7"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Machine malfunction Day 1, no return Day 2</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>opted out of the study once his clinical FDG PET CT was done.</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>opted out of PET/MR</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Multiple Myeloma (MM) Patients</title>
          <description>New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.&#xD;
Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).&#xD;
Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="10"/>
          </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="64.4" spread="11.2"/>
                  </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="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>White</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black or African American</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </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="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Mean Multiple Myeloma Lesions Detected</title>
        <description>The number of lesions detected in the scans will be averaged for each technique. Two techniques (scans) will be tested on Day 1 and two techniques (scans) will be tested on Day 2.</description>
        <time_frame>Day 1, Day 2</time_frame>
        <population>Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Multiple Myeloma (MM) Patients</title>
            <description>New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.&#xD;
Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).&#xD;
Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).</description>
          </group>
        </group_list>
        <measure>
          <title>Mean Multiple Myeloma Lesions Detected</title>
          <description>The number of lesions detected in the scans will be averaged for each technique. Two techniques (scans) will be tested on Day 1 and two techniques (scans) will be tested on Day 2.</description>
          <population>Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups.</population>
          <units>number of lesions</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C-11 acetate PET CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.6" spread="5.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C-11 acetate PET MRI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.4" spread="5.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 FDG PET CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1" spread="1.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 FDG PET MRI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.0" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Visual Image Analysis of Detected Multiple Myeloma Lesions</title>
        <description>The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant).</description>
        <time_frame>Approximately one month after Day 2</time_frame>
        <population>Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups.</population>
        <group_list>
          <group group_id="O1">
            <title>Multiple Myeloma (MM) Patients</title>
            <description>New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.&#xD;
Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).&#xD;
Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).</description>
          </group>
        </group_list>
        <measure>
          <title>Visual Image Analysis of Detected Multiple Myeloma Lesions</title>
          <description>The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant).</description>
          <population>Each participant received both PET drugs by both diagnostic techniques (scans) and is therefore included in the analysis population for the four reporting groups.</population>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="7"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>C-11 acetate PET CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.1" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>C-11 acetate PET MRI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.3" spread="1.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 FDG PET CT</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.9" spread="2.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>18 FDG PET MRI</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.0" spread="1.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Adverse Events were collected from baseline to one day following the last administration of study treatment, for at total of approximately 3 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Multiple Myeloma (MM) Patients</title>
          <description>New diagnosis, high risk smoldering MM, relapse as defined by investigator. Participants received 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant received both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.&#xD;
Fludeoxyglucose: Route of administration was intravenous. Dose of each injection was the standard 5 to 10 millicurie (mCi).&#xD;
Sodium Acetate C11: Route of administration was intravenous. Dose of each injection was 10 mCi (370 MBq).</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="10"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="10"/>
              </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="10"/>
              </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>Michael C. Roarke, M.D.</name_or_title>
      <organization>Mayo Clinic</organization>
      <phone>480-342-0988</phone>
      <email>Roarke.Michael@mayo.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/NCT03262389
org study id: 16-007867
nct id: NCT03262389
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
Investigators are doing this study to determine which of four imaging techniques:
      Fludeoxyglucose Positron Emission Tomography (18 FDG PET) computerized tomography (CT), 18
      FDG PET Magnetic resonance imaging (MRI), C-11 acetate PET CT, and C-11 acetate PET MRI) is
      the best test for finding sites of active myeloma disease.
Participants who are clinically scheduled to undergo F-18 FDG PET/CT myeloma evaluation will
      also undergo F-18 FDG PET/MRI, and C-11 acetate PET CT/MRI. On Day 1 of study, participants
      will undergo F-18 FDG PET/CT-MRI. F-18 FDG radiopharmaceutical is infused intravenously,
      followed by a 60 minute waiting uptake phase. After 60 minutes, participant will undergo
      PET/CT imaging for 30 minutes. At 90 minutes, participant will undergo PET/MRI imaging for 30
      minutes. On Day 2 of study, participants will undergo C-11 PET/CT-MRI. C-11
      radiopharmaceutical is infused intravenously, followed by a 10 minute uptake phase. After 10
      minutes, participant will undergo PET/CT imaging for 30 minutes, followed by a 60 minute
      pause with the participant at rest. At the end of 60 minute pause, the participant is given
      the second C-11 acetate infusion, followed by a 10 minute waiting uptake phase. After 10
      minutes, participant will undergo PET/MRI imaging for 30 minutes. On Day 3, study team member
      makes a phone call to participant for follow up.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Mean Multiple Myeloma Lesions Detected
time frame: Day 1, Day 2
description: The number of lesions detected in the scans will be averaged for each technique. Two techniques (scans) will be tested on Day 1 and two techniques (scans) will be tested on Day 2.
measure: Visual Image Analysis of Detected Multiple Myeloma Lesions
time frame: Approximately one month after Day 2
description: The visual image analysis scale has a range of 0-4: (0 no uptake; 1 benign, 2 probably benign, 3 probably malignant, 4 malignant).
arm group label: Multiple Myeloma Patients
arm group type: Experimental
description: Participants will receive 4 different techniques of diagnosis: Fludeoxyglucose (F-18 FDG) PET/MRI, Sodium Acetate (C-11 acetate) PET/CT, C-11 PET/MRI, and F-18 FDG PET/CT. Each participant will receive both PET drugs by both diagnostic techniques and is therefore included in the analysis population for the four reporting groups.
intervention type: Drug
intervention name: Fludeoxyglucose PET CT
description: Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
arm group label: Multiple Myeloma Patients
other name: F-18 FDG PET CT
intervention type: Drug
intervention name: Sodium Acetate C11 PET CT
description: Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
arm group label: Multiple Myeloma Patients
other name: C-11 acetate PET CT
intervention type: Drug
intervention name: Fludeoxyglucose PET MRI
description: Route of administration is intravenous. Dose of each injection will be the standard 5 to 10 millicurie (mCi).
arm group label: Multiple Myeloma Patients
other name: F-18 FDG PET MRI
intervention type: Drug
intervention name: Sodium Acetate C11 PET MRI
description: Route of administration is intravenous. Dose of each injection will be 10 mCi (370 MBq).
arm group label: Multiple Myeloma Patients
other name: C11 PET MRI
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Michael C Roarke
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Sponsor-Investigator
investigator affiliation: Mayo Clinic
investigator full name: Michael C Roarke, MD
investigator title: Sponsor-Investigator
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Fluorodeoxyglucose F18
sharing ipd: No
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 