<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/NCT02185170</url>
  </required_header>
  <id_info>
    <org_study_id>DCIC 12 03</org_study_id>
    <nct_id>NCT02185170</nct_id>
  </id_info>
  <brief_title>DEPORRA-CoProst: Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections</brief_title>
  <official_title>Assessment of New Fluorescence Imagery Techniques Using Prostate Chips From Transurethral Resections.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Laboratoire TIMC-IMAG</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>FEMTO-ST Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>LLTech laboratory</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Clinical Investigation Center, Technological Innovation (Grenoble and Besancon)</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is divided in 4 different steps:&#xD;
&#xD;
        -  the first step has two different purpose: assess the impact of the storage medium of&#xD;
           fresh prostatic chips on fluorescence signal and adjust the entire chain&#xD;
           (immunolabelling,counter-stain and imaging),&#xD;
&#xD;
        -  the second step is the adaptation of immunolabelling protocol on histopathology slides,&#xD;
           using fresh prostatic tissue,&#xD;
&#xD;
        -  the third step is to validate the use of:&#xD;
&#xD;
             1. the medical device created by the FEMTO-ST institute use for the detection of&#xD;
                fluorescence signal on fresh tissue,&#xD;
&#xD;
             2. the Light-CT scanner use for tissue structural observation.&#xD;
&#xD;
        -  the four step is to check the preservation of morphological structure of tissue under&#xD;
           the effect of laser excitation from the medical device.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Results of 5 first patients show that chips' cauterization interferes the signal&#xD;
  </why_stopped>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">September 2015</completion_date>
  <primary_completion_date type="Actual">September 2015</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>Complete fluorescence measurement over each field of vision.</measure>
    <time_frame>1 day</time_frame>
    <description>Determinate for the anti-PSMA antibody with Alexa Fluor 488 tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Complete fluorescence measurement over each field of vision.</measure>
    <time_frame>1 day</time_frame>
    <description>Determinate for the anti-PSMA antibody with R-Phycoerythrin tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality criteria of the structure of tissue (ordinal qualitative variables).</measure>
    <time_frame>1 day</time_frame>
    <description>Verification of the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluorescence measurements mean.</measure>
    <time_frame>1 day</time_frame>
    <description>Validate the medical device from &quot;FEMTO-ST institute&quot; for the detection of fluorescence signals on fresh prostatic tissue.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comparison of prostatic chips tissue architecture between the images from the Light-CT scanner and standard histopathology slides</measure>
    <time_frame>1 day</time_frame>
    <description>Validate the Light-CT scanner from LLTech laboratory in the fresh prostatic tissue structural observation</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">5</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Fluorescence assesment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients undergo a transurethral resection.&#xD;
There are four different steps in the study:&#xD;
the first step: fresh prostatic tissue of 30 subjects will be use to asses the fluorescence signal and the entire chain,&#xD;
the second step: fresh prostatic tissue of 10 subjects will be used to asses the immunolabelling protocol,&#xD;
the third step: fresh prostatic tissue of 20 subjects will be used to asses the use of the FEMTO-ST institute medical device,&#xD;
the four step: the fresh prostatic tissue from the 10 subjects of the second step will be evaluated to verify the preservation of morphological structure with the use of the Light-CT scanner.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Trans-urethral resection</intervention_name>
    <description>All subjects of the study are going to have a trans-urethral resection of prostate.</description>
    <arm_group_label>Fluorescence assesment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Use of the FEMTO-ST institute medical device</intervention_name>
    <description>The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.</description>
    <arm_group_label>Fluorescence assesment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Use of the Light-CT scanner</intervention_name>
    <description>The Light-CT Scanner is use in the tissue structural observation</description>
    <arm_group_label>Fluorescence assesment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male patient over 18 years old.&#xD;
&#xD;
          -  Patient scheduled for trans-urethral resection of prostate with:&#xD;
&#xD;
               1. prostate specific antigen (PSA) blood level ≤ 4 ng/ml and age &gt; 80 years old&#xD;
&#xD;
               2. a suspected prostate cancer after a digital rectal examination (DRE) and a PSA&#xD;
                  blood level &gt; 50 ng/ml or an existing prostate cancer&#xD;
&#xD;
          -  Patient affiliated to social security or beneficiary of such a regime.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Protected patient referred to in Articles L1121-6 to L1121-8 of the Code of Public&#xD;
             Health&#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>Jean-Luc Descotes, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Grenoble University Hospital, Urology and Anatomopathology Department</name>
      <address>
        <city>Grenoble</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <link>
    <url>http://www.cic-it-grenoble.fr</url>
    <description>Website of the Grenoble Clinical Investigation Center - Technological Innovation</description>
  </link>
  <link>
    <url>http://www-timc.imag.fr/</url>
    <description>Website of the Techniques for biomedical engineering and complexity management - informatics, mathematics and applications - Grenoble laboratory</description>
  </link>
  <link>
    <url>http://www.femto-st.fr/</url>
    <description>Website of FEMTO-ST</description>
  </link>
  <link>
    <url>http://www.urologie-chu-grenoble.com/</url>
    <description>Website of the Grenoble Hospital University Urology Service</description>
  </link>
  <verification_date>September 2015</verification_date>
  <study_first_submitted>June 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>September 21, 2015</last_update_submitted>
  <last_update_submitted_qc>September 21, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 22, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Prostate</keyword>
  <keyword>Cancer</keyword>
  <keyword>Medical Device</keyword>
  <keyword>Fluorescence</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/NCT02185170
org study id: DCIC 12 03
nct id: NCT02185170
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
The aim of this study is divided in 4 different steps:

        -  the first step has two different purpose: assess the impact of the storage medium of
           fresh prostatic chips on fluorescence signal and adjust the entire chain
           (immunolabelling,counter-stain and imaging),

        -  the second step is the adaptation of immunolabelling protocol on histopathology slides,
           using fresh prostatic tissue,

        -  the third step is to validate the use of:

             1. the medical device created by the FEMTO-ST institute use for the detection of
                fluorescence signal on fresh tissue,

             2. the Light-CT scanner use for tissue structural observation.

        -  the four step is to check the preservation of morphological structure of tissue under
           the effect of laser excitation from the medical device.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Complete fluorescence measurement over each field of vision.
time frame: 1 day
description: Determinate for the anti-PSMA antibody with Alexa Fluor 488 tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol.
measure: Complete fluorescence measurement over each field of vision.
time frame: 1 day
description: Determinate for the anti-PSMA antibody with R-Phycoerythrin tracer, the ideal couple of antibody concentration/incubation time giving the highest immunofluorescent signal in the adjustment of fixed tissue sample protocol to fresh tissue sample protocol.
measure: Quality criteria of the structure of tissue (ordinal qualitative variables).
time frame: 1 day
description: Verification of the preservation of morphological structure of tissue under the effect of laser excitation from the medical device.
measure: Fluorescence measurements mean.
time frame: 1 day
description: Validate the medical device from "FEMTO-ST institute" for the detection of fluorescence signals on fresh prostatic tissue.
measure: Comparison of prostatic chips tissue architecture between the images from the Light-CT scanner and standard histopathology slides
time frame: 1 day
description: Validate the Light-CT scanner from LLTech laboratory in the fresh prostatic tissue structural observation
arm group label: Fluorescence assesment
arm group type: Experimental
description: All patients undergo a transurethral resection.
There are four different steps in the study:
the first step: fresh prostatic tissue of 30 subjects will be use to asses the fluorescence signal and the entire chain,
the second step: fresh prostatic tissue of 10 subjects will be used to asses the immunolabelling protocol,
the third step: fresh prostatic tissue of 20 subjects will be used to asses the use of the FEMTO-ST institute medical device,
the four step: the fresh prostatic tissue from the 10 subjects of the second step will be evaluated to verify the preservation of morphological structure with the use of the Light-CT scanner.
intervention type: Procedure
intervention name: Trans-urethral resection
description: All subjects of the study are going to have a trans-urethral resection of prostate.
arm group label: Fluorescence assesment
intervention type: Device
intervention name: Use of the FEMTO-ST institute medical device
description: The FEMTO-ST institute medical device is use to detect prostatic and malignant tissue.
arm group label: Fluorescence assesment
intervention type: Device
intervention name: Use of the Light-CT scanner
description: The Light-CT Scanner is use in the tissue structural observation
arm group label: Fluorescence assesment
criteria: 
gender: Male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Luc Descotes, MD
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
url: http://www.cic-it-grenoble.fr
description: Website of the Grenoble Clinical Investigation Center - Technological Innovation
url: http://www-timc.imag.fr/
description: Website of the Techniques for biomedical engineering and complexity management - informatics, mathematics and applications - Grenoble laboratory
url: http://www.femto-st.fr/
description: Website of FEMTO-ST
url: http://www.urologie-chu-grenoble.com/
description: Website of the Grenoble Hospital University Urology Service
responsible party type: Sponsor
mesh term: Prostatic Neoplasms