<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/NCT03785236</url>
  </required_header>
  <id_info>
    <org_study_id>NL52630.091.15</org_study_id>
    <nct_id>NCT03785236</nct_id>
  </id_info>
  <brief_title>Visualizing Beta Cells After Islet Transplantation</brief_title>
  <acronym>GLP1-transpl</acronym>
  <official_title>Visualizing Beta Cells After Intrahepatic Islet of Langerhans Transplantation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Radboud University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Radboud University Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      In patients with type 1 diabetes (T1D) that have undergone islet of Langerhans&#xD;
      transplantation or are on the waiting list for transplantation, Ga-68-exendin PET imaging is&#xD;
      performed to study the visualization of transplanted islet grafts in patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Detecting damage to islets with a reliable imaging technique could be important for improving&#xD;
      islet survival after transplantation. This could lead to better patient outcomes which would&#xD;
      be of great interest for the treatment of type 1 diabetes. In order to assess the possibility&#xD;
      of visualizing transplanted islet grafts with Ga-68-NODAGA-exendin-4 PET, a proof-of -concept&#xD;
      study is performed in 10 patients with type 1 diabetes who have undergone intrahepatic islet&#xD;
      transplantation with biochemically proven functional islet grafts and 5 patients with type 1&#xD;
      diabetes who are on the waiting list for islet transplantation. The investigators propose to&#xD;
      determine the uptake of the radiolabeled tracer and compare it to functionality of the islet&#xD;
      grafts. These highly relevant data will provide us with more information on the suitability&#xD;
      of GLP-1 receptor imaging for monitoring of transplanted islet mass.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Suitable participants have complicated T1D, often with serious complications, participation is&#xD;
    therefore challenging. Participants also fall within an unique group and few suitable&#xD;
    individuals were available for inclusion.&#xD;
  </why_stopped>
  <start_date type="Actual">June 6, 2016</start_date>
  <completion_date type="Actual">May 27, 2021</completion_date>
  <primary_completion_date type="Actual">May 27, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hepatic uptake of 68Ga-NODAGA-exendin-4</measure>
    <time_frame>1 year</time_frame>
    <description>Hepatic uptake of 68Ga-NODAGA-exendin-4 obtained by quantitative analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Islet graft function</measure>
    <time_frame>1 year</time_frame>
    <description>Correlation of tracer uptake and islet graft function</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">13</enrollment>
  <condition>Type 1 Diabetes Mellitus</condition>
  <arm_group>
    <arm_group_label>Tx-group</arm_group_label>
    <description>T1D patients that received islet of Langerhans transplantation (Tx) at least 3 months earlier</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <description>T1D patients that await islet of Langerhans transplantation</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>68Ga-NODAGA-exendin PET/CT</intervention_name>
    <description>68Ga-NODAGA-exendin PET/CT</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Tx-group</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The population consists of 10 individuals with type 1 diabetes patients who have undergone&#xD;
        intrahepatic islet transplantation at least 3 months earlier at. Furthermore, 5 T1D&#xD;
        patients without an islet transplant will be included as a control for uptake of the&#xD;
        radiotracer in the liver. All participating individuals need to be 18 years or older. In&#xD;
        total, 15 participants will be included.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
        Tx-group:&#xD;
&#xD;
          -  &gt;18 years old&#xD;
&#xD;
          -  T1D patient undergone islet transplantation&#xD;
&#xD;
          -  Clinically proven functional islet graft&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Control group:&#xD;
&#xD;
          -  &gt;18 years old&#xD;
&#xD;
          -  T1D patients who are on the waiting list for islet transplantation&#xD;
&#xD;
          -  Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with synthetic exendin or Dipeptidyl-Peptidase IV inhibitors within the last&#xD;
             3 months&#xD;
&#xD;
          -  Breast feeding&#xD;
&#xD;
          -  Pregnancy or the wish to become pregnant within 6 months&#xD;
&#xD;
          -  Kidney disease&#xD;
&#xD;
          -  Liver disease&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  No signed informed consent&#xD;
&#xD;
        Exclusion criteria for MR:&#xD;
&#xD;
          -  fragments, clips or devices in brain, eyes, spinal canal&#xD;
&#xD;
          -  Implantable defibrillator or pacemaker (wires)&#xD;
&#xD;
          -  Mandibular magnetic implants&#xD;
&#xD;
          -  Neurostimulator, bladder stimulator, non-removable insulin pump&#xD;
&#xD;
          -  Metal tissue-expander in chest&#xD;
&#xD;
          -  Cochlear implant&#xD;
&#xD;
          -  Ossicular replacement prosthesis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Radboud university medical center</name>
      <address>
        <city>Nijmegen</city>
        <state>Gelderland</state>
        <zip>6525 GA</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Uppsala University Hospital</name>
      <address>
        <city>Uppsala</city>
        <zip>SE-751 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
    <country>Sweden</country>
  </location_countries>
  <verification_date>January 2022</verification_date>
  <study_first_submitted>December 20, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>January 29, 2022</last_update_submitted>
  <last_update_submitted_qc>January 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 14, 2022</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, Type 1</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/NCT03785236
org study id: NL52630.091.15
nct id: NCT03785236
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In patients with type 1 diabetes (T1D) that have undergone islet of Langerhans
      transplantation or are on the waiting list for transplantation, Ga-68-exendin PET imaging is
      performed to study the visualization of transplanted islet grafts in patients.
Detecting damage to islets with a reliable imaging technique could be important for improving
      islet survival after transplantation. This could lead to better patient outcomes which would
      be of great interest for the treatment of type 1 diabetes. In order to assess the possibility
      of visualizing transplanted islet grafts with Ga-68-NODAGA-exendin-4 PET, a proof-of -concept
      study is performed in 10 patients with type 1 diabetes who have undergone intrahepatic islet
      transplantation with biochemically proven functional islet grafts and 5 patients with type 1
      diabetes who are on the waiting list for islet transplantation. The investigators propose to
      determine the uptake of the radiolabeled tracer and compare it to functionality of the islet
      grafts. These highly relevant data will provide us with more information on the suitability
      of GLP-1 receptor imaging for monitoring of transplanted islet mass.
observational model: Case-Control
time perspective: Cross-Sectional
measure: Hepatic uptake of 68Ga-NODAGA-exendin-4
time frame: 1 year
description: Hepatic uptake of 68Ga-NODAGA-exendin-4 obtained by quantitative analysis
measure: Islet graft function
time frame: 1 year
description: Correlation of tracer uptake and islet graft function
arm group label: Tx-group
description: T1D patients that received islet of Langerhans transplantation (Tx) at least 3 months earlier
arm group label: Control group
description: T1D patients that await islet of Langerhans transplantation
intervention type: Radiation
intervention name: 68Ga-NODAGA-exendin PET/CT
description: 68Ga-NODAGA-exendin PET/CT
arm group label: Control group
arm group label: Tx-group
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
facility: 
facility: 
country: Netherlands
country: Sweden
responsible party type: Sponsor
mesh term: Diabetes Mellitus, Type 1
sharing ipd: No