<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/NCT03253458</url>
  </required_header>
  <id_info>
    <org_study_id>NL57326.018.17</org_study_id>
    <secondary_id>METC 2017_130</secondary_id>
    <nct_id>NCT03253458</nct_id>
  </id_info>
  <brief_title>Focal Prostate Imaging With CLE and OCT</brief_title>
  <acronym>FPI</acronym>
  <official_title>In-vivo Focal Prostate Imaging With Confocal Laser Endomicroscopy and Optical Coherence Tomography</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Amsterdam UMC, location VUmc</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The current limitations in prostate cancer diagnostics lead to over- and undertreatment for a&#xD;
      significant fraction of patients. Confocal Laser Endomicroscopy (CLE) and Optical Coherence&#xD;
      Tomography (OCT) are focal imaging modalities with potential for in-vivo prostate imaging.&#xD;
      The investigators anticipate that integrating focal imaging with MRI/TRUS fusion will further&#xD;
      improve prostate cancer detection and provides a real-time histopathological threedimensional&#xD;
      representation of the tumor lesions.&#xD;
&#xD;
      This is an investigator-initiated, prospective in-vivo safety and feasibility study with&#xD;
      transperineal template mapping biopsies (TTMB) and two focal imaging methods, CLE and OCT, in&#xD;
      prostate tissue.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study design:&#xD;
&#xD;
      This is an investigator-initiated, prospective in-vivo safety and feasibility study with two&#xD;
      procedures.&#xD;
&#xD;
      Procedure 1 (AMC):&#xD;
&#xD;
      Patients that are indicated for transperineal template mapping biopsies (TTMB) are included&#xD;
      for procedure 1 and will receive transperineal CLE or OCT measurements prior to TTMB.&#xD;
      Procedure 1 is to test the technical feasibility and safety of in-vivo focal imaging with CLE&#xD;
      and OCT. Only if transperineal CLE or OCT measurements are possible, the investigators&#xD;
      proceed with procedure 2.&#xD;
&#xD;
      For procedure 1: 4 patients that are scheduled for TTMB; 2 patients for CLE and 2 patients&#xD;
      for OCT.&#xD;
&#xD;
      Procedure 2 (VUmc):&#xD;
&#xD;
      Patients scheduled for a robot-assisted laparoscopic prostatectomy (RALP) will be included in&#xD;
      procedure 2 and receive transperineal CLE or OCT measurements prior to their surgery. Results&#xD;
      will be correlated with histology by correlating biopsies during the TTMB procedure or with&#xD;
      RALP the measurement trajectory will be marked. After the RALP, the prostate will be cut&#xD;
      exactly through the measurement trajectory for whole mount coupes. In high-risk of&#xD;
      high-intermediate-risk patients receiving an extended pelvic lymph node dissection with the&#xD;
      RALP, ex-vivo CLE measurements will be performed.&#xD;
&#xD;
      For procedure 2: 10 patients that are scheduled for RALP; 5 patients for CLE and 5 patients&#xD;
      for OCT. Intervention: Transperineal CLE or OCT measurements will be performed directly prior&#xD;
      to the TTMB or RALP. The CLE and OCT probes are inserted by a needle with the same diameter&#xD;
      as a biopsy gun. In the case of RALP, measurement trajectories will be marked for&#xD;
      histopathology correlation.&#xD;
&#xD;
      Intervention:&#xD;
&#xD;
      Transperineal CLE or OCT measurements will be performed directly prior to the TTMB or RALP.&#xD;
      The CLE and OCT probes are inserted by a needle with the same diameter as a biopsy gun. In&#xD;
      the case of RALP, measurement trajectories will be marked for histopathology correlation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 11, 2018</start_date>
  <completion_date type="Anticipated">July 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 31, 2019</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>Visual image criteria for CLE and quantitative parameters (attenuation coefficient and residue) of OCT for the characterization of the prostate tissue</measure>
    <time_frame>2 years</time_frame>
    <description>Describing visual characteristics on CLE imaging&#xD;
Attenuation coefficient on OCT imaging calculated with our in-house build software&#xD;
Residue of the OCT imaging calculated with our in-house build software</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical feasibility of CLE and OCT imaging in the prostate by a transperineal approach</measure>
    <time_frame>2 years</time_frame>
    <description>Tissue visualization is not blocked by blood on CLE and OCT imaging&#xD;
OCT image quality determination by visibility in depth</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety of CLE and OCT imaging in the prostate</measure>
    <time_frame>2 years</time_frame>
    <description>Procedure-related adverse events of needle based CLE and OCT</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>Prostate Cancer</condition>
  <arm_group>
    <arm_group_label>Optical imaging</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All consenting patients will undergo Confocal Laser Endomicroscopy or Optical Coherence Tomography imaging prior to biopsy or surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Confocal Laser Endomicroscopy</intervention_name>
    <description>Transperineal confocal laser endomicroscopy or optical coherence tomography measurements. Probe will be placed guided by ultrasound, similar procedure as transperineal template guided mapping biopsies.</description>
    <arm_group_label>Optical imaging</arm_group_label>
    <other_name>Optical Coherence Tomography</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion criteria&#xD;
&#xD;
          -  age ≥ 18 years&#xD;
&#xD;
          -  signed informed consent&#xD;
&#xD;
          -  mpMRI data available&#xD;
&#xD;
        Exclusion criteria&#xD;
&#xD;
          -  Patients with a known allergic reaction to fluorescein cannot participate in this&#xD;
             study.&#xD;
&#xD;
          -  Documented acute prostatitis or urinary tract infections&#xD;
&#xD;
          -  No ability to stop anticoagulant or antiplatelet therapy&#xD;
&#xD;
          -  Medical history of a bleeding disorder or if available platelet Count &lt;140/uL,&#xD;
             prothrombin time &gt;14.5 sec., partial thromboplastin time &gt;34 sec.&#xD;
&#xD;
          -  Major concurrent debilitating illness or ASA ≥4&#xD;
&#xD;
          -  Biological or chemotherapy for PCa&#xD;
&#xD;
          -  Hormonal therapy within last six months&#xD;
&#xD;
          -  Has any medical condition or other circumstances which would significantly decrease&#xD;
             the chances of obtaining reliable data, achieving study objectives, or completing the&#xD;
             study&#xD;
&#xD;
          -  Is incapable of understanding the language in which the information for the patient is&#xD;
             given&#xD;
      </textblock>
    </criteria>
    <gender>Male</gender>
    <gender_based>Yes</gender_based>
    <gender_description>Prostate cancer only occurs in male</gender_description>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Theo M de Reijke, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>AMC-UvA</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Abel Swaan, MSc</last_name>
    <phone>+31205668978</phone>
    <email>a.swaan@amc.uva.nl</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Christophe Mannaerts, MD</last_name>
    <phone>+31205664377</phone>
    <email>c.k.mannaerts@amc.uva.nl</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>AMC University Hospital</name>
      <address>
        <city>Amsterdam</city>
        <state>Noord-Holland</state>
        <zip>1105 AZ</zip>
        <country>Netherlands</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Abel Swaan, Drs. Msc.</last_name>
      <phone>+31 20 568978</phone>
      <email>a.swaan@amc.uva.nl</email>
    </contact>
    <contact_backup>
      <last_name>Christophe Mannaerts, Drs. Msc.</last_name>
      <phone>+31 20 564377</phone>
      <email>c.k.mannaerts@amc.uva.nl</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Netherlands</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 7, 2017</study_first_submitted>
  <study_first_submitted_qc>August 15, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 18, 2017</study_first_posted>
  <last_update_submitted>January 17, 2019</last_update_submitted>
  <last_update_submitted_qc>January 17, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)</investigator_affiliation>
    <investigator_full_name>Dr. T.M. de Reijke</investigator_full_name>
    <investigator_title>Theo M. de Reijke</investigator_title>
  </responsible_party>
  <keyword>Optical coherence tomography</keyword>
  <keyword>Confocal Laser Endomicroscopy</keyword>
  <keyword>Histology</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prostatic Neoplasms</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/NCT03253458
org study id: NL57326.018.17
secondary id: METC 2017_130
nct id: NCT03253458
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The current limitations in prostate cancer diagnostics lead to over- and undertreatment for a
      significant fraction of patients. Confocal Laser Endomicroscopy (CLE) and Optical Coherence
      Tomography (OCT) are focal imaging modalities with potential for in-vivo prostate imaging.
      The investigators anticipate that integrating focal imaging with MRI/TRUS fusion will further
      improve prostate cancer detection and provides a real-time histopathological threedimensional
      representation of the tumor lesions.

      This is an investigator-initiated, prospective in-vivo safety and feasibility study with
      transperineal template mapping biopsies (TTMB) and two focal imaging methods, CLE and OCT, in
      prostate tissue.
Study design:

      This is an investigator-initiated, prospective in-vivo safety and feasibility study with two
      procedures.

      Procedure 1 (AMC):

      Patients that are indicated for transperineal template mapping biopsies (TTMB) are included
      for procedure 1 and will receive transperineal CLE or OCT measurements prior to TTMB.
      Procedure 1 is to test the technical feasibility and safety of in-vivo focal imaging with CLE
      and OCT. Only if transperineal CLE or OCT measurements are possible, the investigators
      proceed with procedure 2.

      For procedure 1: 4 patients that are scheduled for TTMB; 2 patients for CLE and 2 patients
      for OCT.

      Procedure 2 (VUmc):

      Patients scheduled for a robot-assisted laparoscopic prostatectomy (RALP) will be included in
      procedure 2 and receive transperineal CLE or OCT measurements prior to their surgery. Results
      will be correlated with histology by correlating biopsies during the TTMB procedure or with
      RALP the measurement trajectory will be marked. After the RALP, the prostate will be cut
      exactly through the measurement trajectory for whole mount coupes. In high-risk of
      high-intermediate-risk patients receiving an extended pelvic lymph node dissection with the
      RALP, ex-vivo CLE measurements will be performed.

      For procedure 2: 10 patients that are scheduled for RALP; 5 patients for CLE and 5 patients
      for OCT. Intervention: Transperineal CLE or OCT measurements will be performed directly prior
      to the TTMB or RALP. The CLE and OCT probes are inserted by a needle with the same diameter
      as a biopsy gun. In the case of RALP, measurement trajectories will be marked for
      histopathology correlation.

      Intervention:

      Transperineal CLE or OCT measurements will be performed directly prior to the TTMB or RALP.
      The CLE and OCT probes are inserted by a needle with the same diameter as a biopsy gun. In
      the case of RALP, measurement trajectories will be marked for histopathology correlation.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Visual image criteria for CLE and quantitative parameters (attenuation coefficient and residue) of OCT for the characterization of the prostate tissue
time frame: 2 years
description: Describing visual characteristics on CLE imaging
Attenuation coefficient on OCT imaging calculated with our in-house build software
Residue of the OCT imaging calculated with our in-house build software
measure: Technical feasibility of CLE and OCT imaging in the prostate by a transperineal approach
time frame: 2 years
description: Tissue visualization is not blocked by blood on CLE and OCT imaging
OCT image quality determination by visibility in depth
measure: Safety of CLE and OCT imaging in the prostate
time frame: 2 years
description: Procedure-related adverse events of needle based CLE and OCT
arm group label: Optical imaging
arm group type: Experimental
description: All consenting patients will undergo Confocal Laser Endomicroscopy or Optical Coherence Tomography imaging prior to biopsy or surgery.
intervention type: Device
intervention name: Confocal Laser Endomicroscopy
description: Transperineal confocal laser endomicroscopy or optical coherence tomography measurements. Probe will be placed guided by ultrasound, similar procedure as transperineal template guided mapping biopsies.
arm group label: Optical imaging
other name: Optical Coherence Tomography
criteria: 
gender: Male
gender based: Yes
gender description: Prostate cancer only occurs in male
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Theo M de Reijke, MD
role: Principal Investigator
affiliation: AMC-UvA
last name: Abel Swaan, MSc
phone: +31205668978
email: a.swaan@amc.uva.nl
last name: Christophe Mannaerts, MD
phone: +31205664377
email: c.k.mannaerts@amc.uva.nl
facility: 
status: Recruiting
contact: 
contact backup: 
country: Netherlands
responsible party type: Principal Investigator
investigator affiliation: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
investigator full name: Dr. T.M. de Reijke
investigator title: Theo M. de Reijke
mesh term: Prostatic Neoplasms
sharing ipd: No