<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/NCT03019029</url>
  </required_header>
  <id_info>
    <org_study_id>16-006798</org_study_id>
    <nct_id>NCT03019029</nct_id>
  </id_info>
  <brief_title>Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis</brief_title>
  <official_title>Diagnostic Utility of F-18 Florbetapir PET/MR in Peripheral Nerve Amyloidosis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The primary aim of this study will be to examine the diagnostic utility of 18-F Florbetapir&#xD;
      PET/MR (Positron Emission Tomography/Magnetic Resonance) in imaging patients with&#xD;
      pathologically-confirmed systemic amyloidosis involving the peripheral nerves and compare&#xD;
      these results to non-amyloid diseased controls.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with pathologically proven amyloidosis involving the peripheral nervous system will&#xD;
      undergo 18-F Florbetapir PET/MR on a GE (General Electric Healthcare) SIGNA PET/MR scanner. A&#xD;
      control arm comprised of patients with pathologically-confirmed non-amyloid causes of&#xD;
      peripheral neuropathy will also undergo 18-F Florbetapir PET/MR scanning. all images will be&#xD;
      reviewed for peripheral nerve uptake.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Enrolling by invitation</overall_status>
  <start_date type="Actual">March 13, 2017</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</primary_completion_date>
  <phase>Phase 1/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>
    <intervention_model_description>Participants with biopsy proven peripheral nerve amyloidosis will undergo an F-18 Florbetapir PET/MR scan</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Locations of peripheral nerve 18-F Florbetapir uptake</measure>
    <time_frame>50-120 minutes post injection</time_frame>
    <description>Standardized uptake value (SUV)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pattern of F-18 Florbetapir uptake (Heterogeneous vs. Homogeneous, focal vs. diffuse)</measure>
    <time_frame>50-120 minutes post injection</time_frame>
    <description>Heterogeneous vs. Homogeneous, focal vs. diffuse. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>T1 and T2 characteristics (Hypointense, isointense or hyperintense relative to skeletal muscle)</measure>
    <time_frame>50-120 minutes post injection</time_frame>
    <description>Hypointense, isointense or hyperintense relative to skeletal muscle. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Morphologic changes</measure>
    <time_frame>50-120 minutes post injection</time_frame>
    <description>Presence or absence of neural enlargement</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pattern of contrast enhancement (Solid, heterogeneous or peripheral enhancement)</measure>
    <time_frame>50-120 minutes post injection</time_frame>
    <description>Solid, heterogeneous or peripheral enhancement. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Additional sites of 18-F Florbetapir uptake</measure>
    <time_frame>50-120 minutes post injection</time_frame>
    <description>i.e. cardiac myocardium, skeletal muscle, bone marrow</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">10</enrollment>
  <condition>Amyloidosis</condition>
  <arm_group>
    <arm_group_label>Peripheral nerve amyloidosis</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with pathologically-confirmed peripheral nerve amyloidosis will undergo 18-F Florbetapir PET/MR scan on a GE SIGNA PET/MR scanner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>18-F Florbetapir PET/MR scan</intervention_name>
    <description>18-F Florbetapir PET/MR scan, PET/MR on a GE SIGNA PET/MR scanner</description>
    <arm_group_label>Peripheral nerve amyloidosis</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults: 18-100&#xD;
&#xD;
          -  Pathologically-confirmed peripheral nerve amyloidosis or pathologically-confirmed&#xD;
             non-amyloid causes of peripheral neuropathy&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Metallic devices that are not MR safe (cardiac pacers, stents, aneurysm coils, etc.)&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  BMI over 38&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stephen M Broski</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic in Rochester</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</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>January 2023</verification_date>
  <study_first_submitted>January 3, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>January 16, 2023</last_update_submitted>
  <last_update_submitted_qc>January 16, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Stephen M. Broski</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Peripheral Nerve Amyloidosis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT03019029
org study id: 16-006798
nct id: NCT03019029
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
The primary aim of this study will be to examine the diagnostic utility of 18-F Florbetapir
      PET/MR (Positron Emission Tomography/Magnetic Resonance) in imaging patients with
      pathologically-confirmed systemic amyloidosis involving the peripheral nerves and compare
      these results to non-amyloid diseased controls.
Patients with pathologically proven amyloidosis involving the peripheral nervous system will
      undergo 18-F Florbetapir PET/MR on a GE (General Electric Healthcare) SIGNA PET/MR scanner. A
      control arm comprised of patients with pathologically-confirmed non-amyloid causes of
      peripheral neuropathy will also undergo 18-F Florbetapir PET/MR scanning. all images will be
      reviewed for peripheral nerve uptake.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Participants with biopsy proven peripheral nerve amyloidosis will undergo an F-18 Florbetapir PET/MR scan
primary purpose: Diagnostic
masking: None (Open Label)
measure: Locations of peripheral nerve 18-F Florbetapir uptake
time frame: 50-120 minutes post injection
description: Standardized uptake value (SUV)
measure: Pattern of F-18 Florbetapir uptake (Heterogeneous vs. Homogeneous, focal vs. diffuse)
time frame: 50-120 minutes post injection
description: Heterogeneous vs. Homogeneous, focal vs. diffuse. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate.
measure: T1 and T2 characteristics (Hypointense, isointense or hyperintense relative to skeletal muscle)
time frame: 50-120 minutes post injection
description: Hypointense, isointense or hyperintense relative to skeletal muscle. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate.
measure: Morphologic changes
time frame: 50-120 minutes post injection
description: Presence or absence of neural enlargement
measure: Pattern of contrast enhancement (Solid, heterogeneous or peripheral enhancement)
time frame: 50-120 minutes post injection
description: Solid, heterogeneous or peripheral enhancement. This is a categorical variable. There is not a quantitative or semi-quantitative scale that is appropriate.
measure: Additional sites of 18-F Florbetapir uptake
time frame: 50-120 minutes post injection
description: i.e. cardiac myocardium, skeletal muscle, bone marrow
arm group label: Peripheral nerve amyloidosis
arm group type: Experimental
description: Patients with pathologically-confirmed peripheral nerve amyloidosis will undergo 18-F Florbetapir PET/MR scan on a GE SIGNA PET/MR scanner.
intervention type: Other
intervention name: 18-F Florbetapir PET/MR scan
description: 18-F Florbetapir PET/MR scan, PET/MR on a GE SIGNA PET/MR scanner
arm group label: Peripheral nerve amyloidosis
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: No
last name: Stephen M Broski
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: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Stephen M. Broski
investigator title: Principal Investigator
mesh term: Amyloidosis
sharing ipd: No