<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/NCT01691300</url>
  </required_header>
  <id_info>
    <org_study_id>99-2177A</org_study_id>
    <nct_id>NCT01691300</nct_id>
  </id_info>
  <brief_title>C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT</brief_title>
  <acronym>ACTMM</acronym>
  <official_title>C11-Acetate PET/CT in Multiple Myeloma: Added Value to F18-Fluorodeoxyglucose PET/CT for Staging and Response Assessment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chang Gung Memorial Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chang Gung Memorial Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Positron emission tomography combined with computed tomography using carbon-11 acetate (ACT&#xD;
      PET/CT) may help detect lesions before treatment and evaluate response following therapy in&#xD;
      patients with from multiple myeloma (MM). This study aimed to prospectively assess the&#xD;
      clinical utility of ACT PET/CT in MM as compared to the commonly used&#xD;
      F18-fluorodeoxyglucose(FDG).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</primary_completion_date>
  <phase>N/A</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>Pretreatment lesion detection</measure>
    <time_frame>Within 2 weeks before initiation of therapy</time_frame>
    <description>Reference standards: bone marrow examination and whole-body dynamic contrast-enhanced MRI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-induction response assessment</measure>
    <time_frame>Approximately 4 months after initiation of therapy depending on the regimen</time_frame>
    <description>Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-ASCT response assessment</measure>
    <time_frame>Approximately 3 months after ASCT</time_frame>
    <description>Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Progression free survival</measure>
    <time_frame>With 2 years of follow-up time</time_frame>
    <description>Based on clinical follow-up (M-protein or FLC assay, bone marrow examination or imaging findings)</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>ACT PET/CT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dual-tracer ACT/FDG PET/CT and WB-DCE-MRI at baseline (pretreatment), post-induction and post-ASCT (if eligible)</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ACT PET/CT</intervention_name>
    <description>Old tracer but new indication</description>
    <arm_group_label>ACT PET/CT</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least 20 years of age&#xD;
&#xD;
          -  previously untreated&#xD;
&#xD;
          -  complete pre-treatment clinical staging including bone marrow examination&#xD;
&#xD;
          -  written informed consent to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  concurrent active malignant tumor(s)&#xD;
&#xD;
          -  pregnant or breast feeding women&#xD;
&#xD;
          -  non-compliant to PET/CT or to MRI&#xD;
&#xD;
          -  marked renal impairment (contraindicated for contrast-enhanced MRI)&#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>Chieh Lin, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Molecular Imaging Center and Nuclear Medicine, Chang Gung Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chang Gung Memorial Hostpial</name>
      <address>
        <city>Gueishan</city>
        <state>Taoyuan county</state>
        <zip>33305</zip>
        <country>Taiwan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 20, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 24, 2012</study_first_posted>
  <last_update_submitted>November 11, 2015</last_update_submitted>
  <last_update_submitted_qc>November 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 13, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>C11-acetate PET/CT</keyword>
  <keyword>Multiple myeloma</keyword>
  <keyword>Pretreatment staging</keyword>
  <keyword>Response assessment</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01691300
org study id: 99-2177A
nct id: NCT01691300
lead sponsor: 
has dmc: Yes
Positron emission tomography combined with computed tomography using carbon-11 acetate (ACT
      PET/CT) may help detect lesions before treatment and evaluate response following therapy in
      patients with from multiple myeloma (MM). This study aimed to prospectively assess the
      clinical utility of ACT PET/CT in MM as compared to the commonly used
      F18-fluorodeoxyglucose(FDG).
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pretreatment lesion detection
time frame: Within 2 weeks before initiation of therapy
description: Reference standards: bone marrow examination and whole-body dynamic contrast-enhanced MRI
measure: Post-induction response assessment
time frame: Approximately 4 months after initiation of therapy depending on the regimen
description: Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any
measure: Post-ASCT response assessment
time frame: Approximately 3 months after ASCT
description: Reference standard: clinical response based on International Uniform Criteria and bone marrow examination if any
measure: Progression free survival
time frame: With 2 years of follow-up time
description: Based on clinical follow-up (M-protein or FLC assay, bone marrow examination or imaging findings)
arm group label: ACT PET/CT
arm group type: Experimental
description: Dual-tracer ACT/FDG PET/CT and WB-DCE-MRI at baseline (pretreatment), post-induction and post-ASCT (if eligible)
intervention type: Other
intervention name: ACT PET/CT
description: Old tracer but new indication
arm group label: ACT PET/CT
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: No
last name: Chieh Lin, MD, PhD
role: Principal Investigator
affiliation: Department of Molecular Imaging Center and Nuclear Medicine, Chang Gung Memorial Hospital
facility: 
country: Taiwan
responsible party type: Sponsor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell