<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/NCT04460053</url>
  </required_header>
  <id_info>
    <org_study_id>ILP-NfL</org_study_id>
    <nct_id>NCT04460053</nct_id>
  </id_info>
  <brief_title>Neurofilament Light Protein in Peripheral Blood Used as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.</brief_title>
  <acronym>ILP-NfL</acronym>
  <official_title>A Prospective Feasibility Trial Measuring Neurofilament Light Protein in Peripheral Blood as a Biomarker for Neurotoxicity After Isolated Limb Perfusion.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Roger Olofsson Bagge, MD, PhD</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sahlgrenska University Hospital, Sweden</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>
      A prospective feasibility trial initially including 10 patients to investigate if&#xD;
      Neurofilament light protein can be detected in peripheral blood in patients undergoing&#xD;
      Isolated Limb Perfusion with chemotherapeutic agents. This biomarker could act as predictive&#xD;
      biomarker for neurotoxicity after isolated limb perfusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In isolated limb perfusion (ILP) neurotoxicity is a known side effect, this is in spite of&#xD;
      the fact that a relatively mild hyperthermic temperature is used which should be well&#xD;
      tolerated by the nerves and other normal tissues in the limbs. It seems probable that the&#xD;
      neurotoxicity observed after ILP results from both a thermal enhancement of drug toxicity&#xD;
      combined with a local effect of a high tourniquet pressure that is used to isolate the blood&#xD;
      flow. Prevention of regional and systemic toxicity is essential for improving the outcome&#xD;
      after the procedure. It is known that both higher doses of melphalan, higher temperatures and&#xD;
      longer perfusion time correlates to a higher toxicity. The Wieberdink method is a grading&#xD;
      system for the reaction of the normal tissues after ILP and the grading is used as a routine&#xD;
      in ILP today. Neurofilament light protein (NfL) is released into the cerebrospinal fluid&#xD;
      (CSF) during axonal damage and has been shown to be elevated in different forms of dementia.&#xD;
      An NfL assay sensitive enough to measure NfL in blood was recently developed. Its&#xD;
      concentration reflects axonal injury in both central and peripheral nervous system&#xD;
      disorders.The primary aim of this study is to investigate the possibility to measure&#xD;
      neurofilament as a biomarker for peripheral nerve toxicity after isolated limb perfusion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 12, 2019</start_date>
  <completion_date type="Actual">October 25, 2020</completion_date>
  <primary_completion_date type="Actual">September 18, 2020</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>
    <intervention_model_description>A prospective feasibility trial</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neurofilament light protein measurement in peripheral blood</measure>
    <time_frame>1 day postoperatively</time_frame>
    <description>Neurofilament light protein</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurofilament light protein measurement in peripheral blood</measure>
    <time_frame>3 days postoperatively</time_frame>
    <description>Neurofilament light protein</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neurofilament light protein measurement in peripheral blood</measure>
    <time_frame>4 weeks postoperatively</time_frame>
    <description>Neurofilament light protein</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Malignant Melanoma</condition>
  <arm_group>
    <arm_group_label>Neurofilament light protein measurement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Neurofilament light protein measurement in Isolated limb perfused patients</intervention_name>
    <description>A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.</description>
    <arm_group_label>Neurofilament light protein measurement</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patient scheduled for treatment with isolated limb perfusion&#xD;
&#xD;
          2. Age over 18 years&#xD;
&#xD;
          3. Signed informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Roger Olofsson Bagge</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sahlgrenska University Hospital, Department of Sugery</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sahlgrenska University Hospital</name>
      <address>
        <city>Gothenburg</city>
        <zip>413 45</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>March 2021</verification_date>
  <study_first_submitted>May 9, 2019</study_first_submitted>
  <study_first_submitted_qc>July 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>March 16, 2021</last_update_submitted>
  <last_update_submitted_qc>March 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">March 17, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Sahlgrenska University Hospital, Sweden</investigator_affiliation>
    <investigator_full_name>Roger Olofsson Bagge, MD, PhD</investigator_full_name>
    <investigator_title>Associate professor</investigator_title>
  </responsible_party>
  <keyword>toxicity</keyword>
  <keyword>biomarker</keyword>
  <keyword>Neurofilament Light protein</keyword>
  <keyword>In-transit metastasis</keyword>
  <keyword>Hyperthermic isolated limb perfusion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melanoma</mesh_term>
    <mesh_term>Neurotoxicity Syndromes</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/NCT04460053
org study id: ILP-NfL
nct id: NCT04460053
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A prospective feasibility trial initially including 10 patients to investigate if
      Neurofilament light protein can be detected in peripheral blood in patients undergoing
      Isolated Limb Perfusion with chemotherapeutic agents. This biomarker could act as predictive
      biomarker for neurotoxicity after isolated limb perfusion.
In isolated limb perfusion (ILP) neurotoxicity is a known side effect, this is in spite of
      the fact that a relatively mild hyperthermic temperature is used which should be well
      tolerated by the nerves and other normal tissues in the limbs. It seems probable that the
      neurotoxicity observed after ILP results from both a thermal enhancement of drug toxicity
      combined with a local effect of a high tourniquet pressure that is used to isolate the blood
      flow. Prevention of regional and systemic toxicity is essential for improving the outcome
      after the procedure. It is known that both higher doses of melphalan, higher temperatures and
      longer perfusion time correlates to a higher toxicity. The Wieberdink method is a grading
      system for the reaction of the normal tissues after ILP and the grading is used as a routine
      in ILP today. Neurofilament light protein (NfL) is released into the cerebrospinal fluid
      (CSF) during axonal damage and has been shown to be elevated in different forms of dementia.
      An NfL assay sensitive enough to measure NfL in blood was recently developed. Its
      concentration reflects axonal injury in both central and peripheral nervous system
      disorders.The primary aim of this study is to investigate the possibility to measure
      neurofilament as a biomarker for peripheral nerve toxicity after isolated limb perfusion.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A prospective feasibility trial
primary purpose: Diagnostic
masking: None (Open Label)
measure: Neurofilament light protein measurement in peripheral blood
time frame: 1 day postoperatively
description: Neurofilament light protein
measure: Neurofilament light protein measurement in peripheral blood
time frame: 3 days postoperatively
description: Neurofilament light protein
measure: Neurofilament light protein measurement in peripheral blood
time frame: 4 weeks postoperatively
description: Neurofilament light protein
arm group label: Neurofilament light protein measurement
arm group type: Experimental
description: Neurofilament light protein measurements in peripheral blood pre- peri- and postoperatively.
intervention type: Procedure
intervention name: Neurofilament light protein measurement in Isolated limb perfused patients
description: A prospective feasibility trial measuring neurofilament light protein in peripheral blood as a biomarker for neurotoxicity after isolated limb perfusion.
arm group label: Neurofilament light protein measurement
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roger Olofsson Bagge
role: Principal Investigator
affiliation: Sahlgrenska University Hospital, Department of Sugery
facility: 
country: Sweden
responsible party type: Sponsor-Investigator
investigator affiliation: Sahlgrenska University Hospital, Sweden
investigator full name: Roger Olofsson Bagge, MD, PhD
investigator title: Associate professor
mesh term: Melanoma
mesh term: Neurotoxicity Syndromes
sharing ipd: No