<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/NCT02260349</url>
  </required_header>
  <id_info>
    <org_study_id>1308190</org_study_id>
    <secondary_id>2014-000218-67</secondary_id>
    <nct_id>NCT02260349</nct_id>
  </id_info>
  <brief_title>Interest of Indocyanine Green in Neoplastic Prostatic Tissue</brief_title>
  <official_title>Interest of Indocyanine Green in the Neoplastic Prostatic Tissue Characterization and the Peroperative Surgical Margins Detection During a Radical Prostatectomy.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Saint Etienne</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Saint Etienne</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prostate cancer, with more than 70,000 new cases and 8900 deaths a year in France, is a major&#xD;
      public health problem. Until 28% of patients treated with surgery will present a positive&#xD;
      surgical margin resulting in an incomplete clearance of the tumoral process and exposing so&#xD;
      the patient at a local, systemic recurrence and increased morbidity. An increasing number of&#xD;
      international publications have shown (ICG) was interesting for the detection of the sentinel&#xD;
      lymph node, in the surgery of tumors of type hepatocarcinoma and liver metastases from&#xD;
      colorectal diseases, but also in the surgery of the kidney, bladder or breast. ICG has&#xD;
      affinity for tumor and tissues around the tumor related to micro-vascular histology for a&#xD;
      localized and specific deposit (EPR effect).&#xD;
&#xD;
      The detection of ICG 's deposits is now possible with to the use of a device which allow to&#xD;
      visualize the infra-red fluorescence (NIR; Near Infra-Red) for objects larger than 0.15 mm.&#xD;
      Thanks to this feature, the location of residual tumor tissue when performing a radical&#xD;
      prostatectomy could be made much easier.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The ability of ICG to detect a surgical margin positive intraoperatively has never be&#xD;
      evaluated. We want to perform a monocentric prospective ex-vivo pilot in order to evaluate&#xD;
      the diagnostic performance of fluorescence in the detection of surgical margins compared to&#xD;
      pathologic analysis. This study will be conducted in 37 patients operated on for a radical&#xD;
      prostatectomy after systemic injection of 0, 25 mg/Kg of ICG 24 h before the surgery. The&#xD;
      fluorescence analysis will be performed in the operation room and then specimen will be sent&#xD;
      to the laboratory for an analysis as usual. Two pieces of prostate will be prelevated&#xD;
      according to a protocol. The histopathological procedure will be performed without knowledge&#xD;
      of fluorescence analysis. Except the ICG injection the medical procedure won't be changed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Scientific coordinator left the hospital&#xD;
  </why_stopped>
  <start_date>April 2014</start_date>
  <completion_date type="Actual">February 2016</completion_date>
  <primary_completion_date type="Actual">February 2016</primary_completion_date>
  <phase>Phase 3</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>Sensitivity of indocyanine green</measure>
    <time_frame>24h after indocyanine green infusion</time_frame>
    <description>Sensitivity (true positive) of the fluorescence due to indocyanine green to detect neoplasm tissue in prostatic biopsy compared to histological analysis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Specificity of indocyanine green</measure>
    <time_frame>24h after indocyanine green infusion</time_frame>
    <description>Specificity (true negative) of the fluorescence due to indocyanine green to detect neoplasm tissue in prostatic biopsy compared to histological analysis</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Prostatic Neoplasms</condition>
  <arm_group>
    <arm_group_label>patient with Indocyanine green infusion</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Infusion of Indocyanine Green 0,25 mg/Kg 24h before prostatic surgery</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>indocyanine green infusion</intervention_name>
    <description>intravenous injection (0,25mg/kg) of the indocyanine green 24h before prostatic surgery.</description>
    <arm_group_label>patient with Indocyanine green infusion</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with prostatic cancer proved by biopsy and needing total prostatectomy with&#xD;
             or without curettage.&#xD;
&#xD;
          -  Patient affiliated to a social security scheme&#xD;
&#xD;
          -  Patient has given its informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  contra-indication to surgery&#xD;
&#xD;
          -  non confirmed adenocarcinoma diagnostic&#xD;
&#xD;
          -  antecedent of prostatic cancer treatment&#xD;
&#xD;
          -  antecedent of pelvic surgery&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas MOTTET, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU SAINT-ETIENNE</affiliation>
  </overall_official>
  <removed_countries>
    <country>France</country>
  </removed_countries>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 25, 2014</study_first_submitted>
  <study_first_submitted_qc>October 6, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 9, 2014</study_first_posted>
  <last_update_submitted>March 9, 2016</last_update_submitted>
  <last_update_submitted_qc>March 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 10, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostatic Neoplasms</keyword>
  <keyword>Prostate cancer</keyword>
  <keyword>surgical margins</keyword>
  <keyword>indocyanine green</keyword>
  <keyword>characterization</keyword>
  <keyword>prostatectomy</keyword>
  <keyword>peroperative</keyword>
  <keyword>detection</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT02260349
org study id: 1308190
secondary id: 2014-000218-67
nct id: NCT02260349
lead sponsor: 
has dmc: No
Prostate cancer, with more than 70,000 new cases and 8900 deaths a year in France, is a major
      public health problem. Until 28% of patients treated with surgery will present a positive
      surgical margin resulting in an incomplete clearance of the tumoral process and exposing so
      the patient at a local, systemic recurrence and increased morbidity. An increasing number of
      international publications have shown (ICG) was interesting for the detection of the sentinel
      lymph node, in the surgery of tumors of type hepatocarcinoma and liver metastases from
      colorectal diseases, but also in the surgery of the kidney, bladder or breast. ICG has
      affinity for tumor and tissues around the tumor related to micro-vascular histology for a
      localized and specific deposit (EPR effect).

      The detection of ICG 's deposits is now possible with to the use of a device which allow to
      visualize the infra-red fluorescence (NIR; Near Infra-Red) for objects larger than 0.15 mm.
      Thanks to this feature, the location of residual tumor tissue when performing a radical
      prostatectomy could be made much easier.
The ability of ICG to detect a surgical margin positive intraoperatively has never be
      evaluated. We want to perform a monocentric prospective ex-vivo pilot in order to evaluate
      the diagnostic performance of fluorescence in the detection of surgical margins compared to
      pathologic analysis. This study will be conducted in 37 patients operated on for a radical
      prostatectomy after systemic injection of 0, 25 mg/Kg of ICG 24 h before the surgery. The
      fluorescence analysis will be performed in the operation room and then specimen will be sent
      to the laboratory for an analysis as usual. Two pieces of prostate will be prelevated
      according to a protocol. The histopathological procedure will be performed without knowledge
      of fluorescence analysis. Except the ICG injection the medical procedure won't be changed.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Sensitivity of indocyanine green
time frame: 24h after indocyanine green infusion
description: Sensitivity (true positive) of the fluorescence due to indocyanine green to detect neoplasm tissue in prostatic biopsy compared to histological analysis
measure: Specificity of indocyanine green
time frame: 24h after indocyanine green infusion
description: Specificity (true negative) of the fluorescence due to indocyanine green to detect neoplasm tissue in prostatic biopsy compared to histological analysis
arm group label: patient with Indocyanine green infusion
arm group type: Experimental
description: Infusion of Indocyanine Green 0,25 mg/Kg 24h before prostatic surgery
intervention type: Drug
intervention name: indocyanine green infusion
description: intravenous injection (0,25mg/kg) of the indocyanine green 24h before prostatic surgery.
arm group label: patient with Indocyanine green infusion
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas MOTTET, PhD
role: Principal Investigator
affiliation: CHU SAINT-ETIENNE
country: France
responsible party type: Sponsor
mesh term: Prostatic Neoplasms