<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/NCT03304223</url>
  </required_header>
  <id_info>
    <org_study_id>201501004</org_study_id>
    <nct_id>NCT03304223</nct_id>
  </id_info>
  <brief_title>IL2 Imaging in Renal Transplantation</brief_title>
  <official_title>A Proof of Concept Study for [18F]FB-IL2 PET Imaging of Infiltrating T Cells After Renal Transplantation; a Diagnostic Tool for Acute Rejection</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Medical Center Groningen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Medical Center Groningen</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>
      After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and&#xD;
      accurate diagnosis is vital for implementation of additional immunosuppressive therapy.&#xD;
      Currently, a renal biopsy is essential for the diagnosis of renal allograft rejection.&#xD;
      However, this is an intervention associated with complications like bleeding, patient&#xD;
      discomfort and hospital admission. Additionally, limited biopsy sample size may lead to false&#xD;
      negative results. So, the introduction of a new non-invasive diagnostic tool for allograft&#xD;
      rejection could have major implications for the care of renal transplant recipients. For the&#xD;
      purpose of visualizing infiltrating T lymphocytes with positron emission tomography (PET),&#xD;
      the tracer 18-Fluor-Interleukin-2 ([18F]FB-IL2) has been developed. The investigators&#xD;
      hypothesized that a high correlation exists between [18F]FB-IL2 uptake and the extend of T&#xD;
      cell infiltration into renal transplants with signs of rejection&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">December 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2023</completion_date>
  <primary_completion_date type="Actual">December 1, 2022</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>The ability of the [18F]FB-IL2 PET to detect renal transplant rejection</measure>
    <time_frame>At study day 2, when PET procedure is performed.</time_frame>
    <description>Uptake of [18F]FB-IL2 in the renal transplant will be correlated to inflammatory infiltrate and histological BANFF score.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Uptake of [18F]FB-IL2 and correlation with renal function</measure>
    <time_frame>At study day 2, when PET procedure is performed.</time_frame>
    <description>Uptake of [18F]FB-IL2 in the renal transplant will be correlated to renal function as measured by 24-hours urine clearance and the Modification of Diet in Renal Disease equation (MDRD).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Uptake of [18F]FB-IL2 and correlation with T-cell subpopulations</measure>
    <time_frame>At study day 2, when PET procedure is performed.</time_frame>
    <description>Uptake of [18F]FB-IL2 in the renal transplant will be correlated to T-cell subpopulations in urine and blood.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Kidney Transplant Rejection</condition>
  <arm_group>
    <arm_group_label>[18F]FB-IL2 PET scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Renal transplant recipients with a clinical suspicion for renal transplant rejection.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>[18F]FB-IL2 PET scan</intervention_name>
    <description>[18F]FB-IL2 PET scan procedure</description>
    <arm_group_label>[18F]FB-IL2 PET scan</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Female or male aged between 18 and 80 years.&#xD;
&#xD;
          -  Renal Transplant recipients&#xD;
&#xD;
          -  The patient understands the purpose and risks of the study and has given written&#xD;
             informed consent to participate in the study.&#xD;
&#xD;
          -  All patients will have a clinical indication for renal biopsy.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with multiple-organ transplants.&#xD;
&#xD;
          -  Female patients who are pregnant or unwilling to use adequate contraception during the&#xD;
             study.&#xD;
&#xD;
          -  Claustrophobia&#xD;
&#xD;
          -  Altered mental status, or any psychiatric condition that would prohibit the&#xD;
             understanding or rendering of informed consent.&#xD;
&#xD;
          -  A clinical reason for an immediate start of a therapeutic intervention with&#xD;
             immunosuppressive medication.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jan-Stephan F Sanders, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Medical Center Groningen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Groningen</name>
      <address>
        <city>Groningen</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>September 22, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 6, 2017</study_first_posted>
  <last_update_submitted>May 9, 2023</last_update_submitted>
  <last_update_submitted_qc>May 9, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Groningen</investigator_affiliation>
    <investigator_full_name>J.S.F. Sanders</investigator_full_name>
    <investigator_title>MD, PhD</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03304223
org study id: 201501004
nct id: NCT03304223
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
After renal transplantation 5 to 10% of patients experience allograft rejection. Rapid and
      accurate diagnosis is vital for implementation of additional immunosuppressive therapy.
      Currently, a renal biopsy is essential for the diagnosis of renal allograft rejection.
      However, this is an intervention associated with complications like bleeding, patient
      discomfort and hospital admission. Additionally, limited biopsy sample size may lead to false
      negative results. So, the introduction of a new non-invasive diagnostic tool for allograft
      rejection could have major implications for the care of renal transplant recipients. For the
      purpose of visualizing infiltrating T lymphocytes with positron emission tomography (PET),
      the tracer 18-Fluor-Interleukin-2 ([18F]FB-IL2) has been developed. The investigators
      hypothesized that a high correlation exists between [18F]FB-IL2 uptake and the extend of T
      cell infiltration into renal transplants with signs of rejection
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: The ability of the [18F]FB-IL2 PET to detect renal transplant rejection
time frame: At study day 2, when PET procedure is performed.
description: Uptake of [18F]FB-IL2 in the renal transplant will be correlated to inflammatory infiltrate and histological BANFF score.
measure: Uptake of [18F]FB-IL2 and correlation with renal function
time frame: At study day 2, when PET procedure is performed.
description: Uptake of [18F]FB-IL2 in the renal transplant will be correlated to renal function as measured by 24-hours urine clearance and the Modification of Diet in Renal Disease equation (MDRD).
measure: Uptake of [18F]FB-IL2 and correlation with T-cell subpopulations
time frame: At study day 2, when PET procedure is performed.
description: Uptake of [18F]FB-IL2 in the renal transplant will be correlated to T-cell subpopulations in urine and blood.
arm group label: [18F]FB-IL2 PET scan
arm group type: Experimental
description: Renal transplant recipients with a clinical suspicion for renal transplant rejection.
intervention type: Diagnostic Test
intervention name: [18F]FB-IL2 PET scan
description: [18F]FB-IL2 PET scan procedure
arm group label: [18F]FB-IL2 PET scan
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Jan-Stephan F Sanders, MD, PhD
role: Principal Investigator
affiliation: University Medical Center Groningen
facility: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Groningen
investigator full name: J.S.F. Sanders
investigator title: MD, PhD
sharing ipd: Undecided