<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/NCT01710371</url>
  </required_header>
  <id_info>
    <org_study_id>A9001458</org_study_id>
    <nct_id>NCT01710371</nct_id>
  </id_info>
  <brief_title>Quantitative 18F-AV-133 PET Imaging in Subjects With Diabetes and Healthy Controls</brief_title>
  <official_title>Quantitative PET Imaging of Pancreatic Beta-Cell Mass in Healthy Overweight/Obese Subjects, Subjects With Prediabetes, and Type 2 Diabetes Patients With 18F-FP-DTBZ (18F-AV-133)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Avid Radiopharmaceuticals</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Pfizer</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Avid Radiopharmaceuticals</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late&#xD;
      type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects.&#xD;
      These subjects will also be evaluated for beta-cell function as measured by the insulin and&#xD;
      C-peptide response to a challenge with intravenous arginine under basal and glucose enhanced&#xD;
      conditions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>December 2012</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133</measure>
    <time_frame>PET visit 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133</measure>
    <time_frame>PET visit 1</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133</measure>
    <time_frame>PET visit 1</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Type 2 Diabetes</condition>
  <arm_group>
    <arm_group_label>Arginine Stimulation Testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Establish the methodology for glucose enhanced arginine stimulation testing (AST).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PET Imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Determine if pancreatic PET-determined binding measures of 18F-AV-133 differ in up to 60 subjects determined to be at one of four stages of the natural history of Type 2 Diabetes: Healthy Overweight/obese Volunteers (HOV), Subjects with Pre-diabetes (PD) and Type 2 Diabetes mellitus (T2DM).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>18F-AV-133</intervention_name>
    <description>296 MBq (8 mCi)</description>
    <arm_group_label>PET Imaging</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>10% Arginine Hydrochloride-R-Gene 10</intervention_name>
    <arm_group_label>Arginine Stimulation Testing</arm_group_label>
    <arm_group_label>PET Imaging</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male and/or female subjects of non-childbearing potential between the ages of 30 and&#xD;
             65 years inclusive.&#xD;
&#xD;
          -  Able to tolerate PET, PET/CT and MR imaging&#xD;
&#xD;
          -  Estimated creatinine clearance &gt;= 60mL/min&#xD;
&#xD;
          -  Informed consent documents signed and dated by subject&#xD;
&#xD;
          -  Subjects must be willing and able to comply with all scheduled visits, treatments&#xD;
             laboratory tests, scans and other study procedures.&#xD;
&#xD;
          -  In addition, subjects must meet classification requirements for one of the following&#xD;
&#xD;
               1. Healthy Overweight&#xD;
&#xD;
               2. Pre-diabetes&#xD;
&#xD;
               3. T2DM&#xD;
&#xD;
          -  (T2DM only) Subjects with other chronic medical conditions (besides diabetes) that are&#xD;
             well controlled and stable on medication are acceptable for inclusion in this study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects who are affiliated with or relatives of staff members of either the site or&#xD;
             Pfizer directly involved in the conduct of the trial.&#xD;
&#xD;
          -  Conditions which in the opinion of the study investigator may interfere with the&#xD;
             subject's ability to participate in the study&#xD;
&#xD;
          -  History of allergic reaction to drug/contrast agent or history of drug/alcohol abuse&#xD;
&#xD;
          -  Subjects who have received investigational medications within the last 30 days or a&#xD;
             radiopharmaceutical in the past 7 days.&#xD;
&#xD;
          -  Pregnant or nursing females; females of childbearing potential.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chief Medical Officer</last_name>
    <role>Study Director</role>
    <affiliation>Avid Radiopharmaceuticals</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Research Site</name>
      <address>
        <city>New Haven</city>
        <state>Connecticut</state>
        <zip>06511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>October 17, 2012</study_first_submitted>
  <study_first_submitted_qc>October 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 19, 2012</study_first_posted>
  <last_update_submitted>November 12, 2015</last_update_submitted>
  <last_update_submitted_qc>November 12, 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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Diabetes Mellitus</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</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/NCT01710371
org study id: A9001458
nct id: NCT01710371
lead sponsor: 
collaborator: 
has dmc: No
To evaluate 18F-AV-133 imaging of the pancreas in patients with early type 2 diabetes, late
      type 2 diabetes, subjects with pre-diabetes and in healthy overweight/obese control subjects.
      These subjects will also be evaluated for beta-cell function as measured by the insulin and
      C-peptide response to a challenge with intravenous arginine under basal and glucose enhanced
      conditions.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Optimal PET-determined mean pancreatic Binding Potential of 18F-AV-133
time frame: PET visit 1
measure: Optimal PET-determined mean pancreatic Standardized Uptake Value (SUV) of 18F-AV-133
time frame: PET visit 1
measure: Optimal PET-determined mean pancreatic Volume of Distribution (VT) of 18F-AV-133
time frame: PET visit 1
arm group label: Arginine Stimulation Testing
arm group type: Experimental
description: Establish the methodology for glucose enhanced arginine stimulation testing (AST).
arm group label: PET Imaging
arm group type: Experimental
description: Determine if pancreatic PET-determined binding measures of 18F-AV-133 differ in up to 60 subjects determined to be at one of four stages of the natural history of Type 2 Diabetes: Healthy Overweight/obese Volunteers (HOV), Subjects with Pre-diabetes (PD) and Type 2 Diabetes mellitus (T2DM).
intervention type: Drug
intervention name: 18F-AV-133
description: 296 MBq (8 mCi)
arm group label: PET Imaging
intervention type: Drug
intervention name: 10% Arginine Hydrochloride-R-Gene 10
arm group label: Arginine Stimulation Testing
arm group label: PET Imaging
criteria: 
gender: All
minimum age: 30 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Chief Medical Officer
role: Study Director
affiliation: Avid Radiopharmaceuticals
facility: 
country: United States
responsible party type: Sponsor
mesh term: Diabetes Mellitus
mesh term: Diabetes Mellitus, Type 2