<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/NCT03779815</url>
  </required_header>
  <id_info>
    <org_study_id>UUH-2018-05-034-001</org_study_id>
    <nct_id>NCT03779815</nct_id>
  </id_info>
  <brief_title>Detection of Amyloidosis in Multiple Myeloma Patients by [18F]Florbetaben Positron Emission Tomography</brief_title>
  <acronym>PET</acronym>
  <official_title>A Pilot Phase 2, Open-label, Non-randomized, Single Center Study to Explore Diagnostic Validity of [18F]Florbetaben Positron Emission Tomography for Detecting Amyloidosis in Multiple Myeloma Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ulsan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ulsan University Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      [18F]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic&#xD;
      amyloidosis.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Diagnostic validity of [18F]Florbetaben PET for detecting amyloidosis will be assessed in&#xD;
      subjects with multiple myeloma.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 20, 2018</start_date>
  <completion_date type="Actual">February 28, 2019</completion_date>
  <primary_completion_date type="Actual">February 28, 2019</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>sensitivity and specificity per patient analysis</measure>
    <time_frame>Up to 6 months after [18F]Florbetaben PET/CT scanning</time_frame>
    <description>Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>sensitivity and specificity per organ analysis</measure>
    <time_frame>Up to 6 months after [18F]Florbetaben PET/CT scanning</time_frame>
    <description>Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of affected organs with clinical, laboratory, radiological, or histopathological evidence of amyloidosis</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation with severity</measure>
    <time_frame>Up to 6 months after [18F]Florbetaben PET/CT scanning</time_frame>
    <description>Correlation of [18F]Florbetaben activity with clinical/radiological/histopathological indices of amyloidosis severity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>Up to 28 days after [18F]Florbetaben PET/CT scanning</time_frame>
    <description>Adverse events will be monitored.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">14</enrollment>
  <condition>Multiple Myeloma</condition>
  <arm_group>
    <arm_group_label>[18F]Florbetaben PET/CT imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Maximally 18 subjects with multiple myeloma (up to 6 subjects in whom amyloidosis in suspected and up to 12 subjects in whom amyloidosis is not suspected)&#xD;
Intravenous injection of [18F]Florbetaben and PET/CT scanning&#xD;
Intervention: Drug ([18F]Florbetaben)</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>[18F]Florbetaben</intervention_name>
    <description>Drug: [18F]Florbetaben&#xD;
[18F]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma&#xD;
Other name: Neuraceq&#xD;
Amount: 300 MBq ± 20% bolus, 10mL intravenously</description>
    <arm_group_label>[18F]Florbetaben PET/CT imaging</arm_group_label>
    <other_name>neuraceq</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject is over 19 years old and male or female of any race/ethnicity&#xD;
&#xD;
          -  Subject has been diagnosed with multiple myeloma by a hemato-oncology specialist&#xD;
&#xD;
          -  Subject has undergone clinical, laboratory, or imaging work-up if amyloidosis is&#xD;
             suspected&#xD;
&#xD;
          -  Subject has voluntarily agreed to participate in the study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject or subject's legally acceptable representative does not provide written&#xD;
             informed consent.&#xD;
&#xD;
          -  Female subject is pregnant or nursing. Exclusion of the possibility of pregnancy is&#xD;
             made by one of the following: 1) Woman is physiologically post-menopausal (cessation&#xD;
             of menses for more than 2 years), 2) woman is surgically sterile (has had a documented&#xD;
             bilateral oophorectomy and/or documented hysterectomy, or 3) if the woman is of&#xD;
             childbearing potential, a serum or urine pregnancy test performed within 24 hours&#xD;
             immediately prior to administration of [18F]Florbetaben has to be negative and the&#xD;
             women is advised to apply contraceptive measures during her participation in this&#xD;
             study.&#xD;
&#xD;
          -  Subject has concurrent severe and/or uncontrolled and/or unstable medical disease&#xD;
             (which could compromise participation in the study) in the judgment of the&#xD;
             investigator.&#xD;
&#xD;
          -  Subject has received any investigational drugs or devices within four weeks prior to&#xD;
             the study enrollment.&#xD;
&#xD;
          -  Subject has been previously included in this study.&#xD;
&#xD;
          -  Subject has any other condition or personal circumstances that, in the judgment of the&#xD;
             investigator, might make collection of complete data difficult or impossible.&#xD;
&#xD;
          -  Subject is allergic to Florbetaben or any of ingredients of Florbetaben&#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>Jae-Cheol Jo, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ulsan University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ulsan University Hospital</name>
      <address>
        <city>Ulsan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>September 12, 2018</study_first_submitted>
  <study_first_submitted_qc>December 16, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ulsan University Hospital</investigator_affiliation>
    <investigator_full_name>Jae-Cheol Jo</investigator_full_name>
    <investigator_title>Assistant professor</investigator_title>
  </responsible_party>
  <keyword>multiple myeloma</keyword>
  <keyword>amyloidosis</keyword>
  <keyword>Florbetaben</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>
    <mesh_term>Amyloidosis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03779815
org study id: UUH-2018-05-034-001
nct id: NCT03779815
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
[18F]Florbetaben PET/CT imaging will noninvasively assess amyloid deposition in systemic
      amyloidosis.
Diagnostic validity of [18F]Florbetaben PET for detecting amyloidosis will be assessed in
      subjects with multiple myeloma.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: sensitivity and specificity per patient analysis
time frame: Up to 6 months after [18F]Florbetaben PET/CT scanning
description: Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of subjects with clinical, laboratory, radiological, or histopathological evidence of amyloidosis
measure: sensitivity and specificity per organ analysis
time frame: Up to 6 months after [18F]Florbetaben PET/CT scanning
description: Sensitivity and specificity of [18F]Florbetaben PET/CT for the diagnosis of affected organs with clinical, laboratory, radiological, or histopathological evidence of amyloidosis
measure: Correlation with severity
time frame: Up to 6 months after [18F]Florbetaben PET/CT scanning
description: Correlation of [18F]Florbetaben activity with clinical/radiological/histopathological indices of amyloidosis severity
measure: Adverse events
time frame: Up to 28 days after [18F]Florbetaben PET/CT scanning
description: Adverse events will be monitored.
arm group label: [18F]Florbetaben PET/CT imaging
arm group type: Experimental
description: Maximally 18 subjects with multiple myeloma (up to 6 subjects in whom amyloidosis in suspected and up to 12 subjects in whom amyloidosis is not suspected)
Intravenous injection of [18F]Florbetaben and PET/CT scanning
Intervention: Drug ([18F]Florbetaben)
intervention type: Drug
intervention name: [18F]Florbetaben
description: Drug: [18F]Florbetaben
[18F]Florbetaben PET/CT Imaging for detecting amyloidosis in multiple myeloma
Other name: Neuraceq
Amount: 300 MBq ± 20% bolus, 10mL intravenously
arm group label: [18F]Florbetaben PET/CT imaging
other name: neuraceq
criteria: 
gender: All
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Jae-Cheol Jo, PhD
role: Principal Investigator
affiliation: Ulsan University Hospital
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Ulsan University Hospital
investigator full name: Jae-Cheol Jo
investigator title: Assistant professor
mesh term: Multiple Myeloma
mesh term: Neoplasms, Plasma Cell
mesh term: Amyloidosis
sharing ipd: No