<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/NCT02224885</url>
  </required_header>
  <id_info>
    <org_study_id>MKT-IR-HEGP-2014</org_study_id>
    <nct_id>NCT02224885</nct_id>
  </id_info>
  <brief_title>Needle-based Confocal Laser Endomicroscopy in Fluoroscopy-guided Procedures</brief_title>
  <official_title>Needle-based Confocal Laser Endomicroscopy in Fluoroscopy-guided Procedures for Lung Applications (Biopsies and Ablation) and Liver Procedures in Interventional Radiology: a Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mauna Kea Technologies</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mauna Kea Technologies</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study is a prospective study in order to demonstrate the technical feasibility and&#xD;
      safety of doing endomicroscopic imaging during interventional radiology procedure in two main&#xD;
      indications: lung and liver.&#xD;
&#xD;
      This innovative study will involve the use of probe-based confocal laser endomicroscopy. The&#xD;
      proposed study is a feasibility study.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Interventional radiology is a medical sub-specialty of radiology which utilizes&#xD;
      minimally-invasive image-guided procedures to diagnose and treat diseases in nearly every&#xD;
      organ. The concept behind interventional radiology is to diagnose and treat patients using&#xD;
      less invasive techniques currently available in order to minimize risk to the patient and&#xD;
      improve health outcomes.&#xD;
&#xD;
      For many years, surgery was the only treatment available for many conditions. Today,&#xD;
      interventional radiology treatments are frst-line care for a wide variety of conditions.&#xD;
      Patients should be offered the least invasive option frst. It is important to get a second&#xD;
      opinion and know all of your treatment options before consenting to any procedure or surgery.&#xD;
      Interventional radiologists are specialists in minimally invasive treatments, have a unique&#xD;
      breadth of training and provide consults to every type of specialist.&#xD;
&#xD;
      Surgical removal of liver tumors offers the best chance for a cure. Unfortunately, liver&#xD;
      tumors are often inoperable because the tumor may be too large, or has grown into major blood&#xD;
      vessels or other vital structures. Sometimes, many small tumors are spread throughout the&#xD;
      liver, making surgery too risky or impractical. Surgical removal is not possible for more&#xD;
      than two-thirds of primary liver cancer patients and 90 percent of patients with secondary&#xD;
      liver cancer.&#xD;
&#xD;
      The objectives of this study are to demonstrate the technical feasibility and safety of doing&#xD;
      endomicroscopic imaging during interventional radiology procedure in two main indications:&#xD;
      lung and liver.&#xD;
&#xD;
      The goal is to determine whether:&#xD;
&#xD;
        -  Cellvizio insertion during the interventional procedure leads to change in known adverse&#xD;
           events / serious adverse events rate during and one month after the procedure&#xD;
&#xD;
        -  It is technically feasible to obtain images from Cellvizio during an interventional&#xD;
           radiology procedure&#xD;
&#xD;
        -  Cellvizio is a helpful assistance to increase the efficacy of biopsy which require to&#xD;
           evaluate its accuracy eg. the predictive value of Cellvizio compared to pathology&#xD;
           results.&#xD;
&#xD;
      Secondary goals are to assess:&#xD;
&#xD;
        -  Benefit of spatial accuracy for the yield of the biopsy procedure and potential&#xD;
           subsequent intervention, e.g. radiofrequency ablation.&#xD;
&#xD;
        -  Regarding lung biopsies and lung ablation, potential increase of a database to refine&#xD;
           image interpretation criteria with pathologists.&#xD;
&#xD;
        -  In liver application, the goal is to build a database of images and define image&#xD;
           interpretation criteria with pathologists to start image interpretation work.&#xD;
&#xD;
        -  The predictive value of biopsies with Cellvizio assistance for lung or liver tumor&#xD;
           biopsies.&#xD;
&#xD;
      For both applications, technical feedback from the physicians is expected on how they think&#xD;
      the combined use of the devices could change the care path. E.g. a certain step in the&#xD;
      workflow might become obsolete or the workflow could lead to fewer patient visits.&#xD;
&#xD;
      For the safety of this protocol, the use of endomicroscopy will not change in any way the&#xD;
      patient management and standard procedure, including the diagnosis nor treatment decisions.&#xD;
      All the adverse events / serious adverse events will be noted during the procedure and one&#xD;
      week after the procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">March 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Measure adverse events frequency in the use of mini probes on the tumor</measure>
    <time_frame>Up to 1 week</time_frame>
    <description>Assessment of the safety of inserting Cellvizio confocal miniprobe in the tumor (nor increase in bleeding or tumor cell dissemination) through the frequency, type and severity of adverse events</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Creation of image bank</measure>
    <time_frame>Up to 6 months</time_frame>
    <description>A frst creation of an atlas of endomicroscopic images obtained in interventional radiology in the liver - for the lung, the atlas established for peripheral lung nodules in bronchoscopy applications will serve as a reference and will be tested prospectively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Yield of nCLE (needle-based confocal laser endomicroscopy)-targeted Fluoroscopy-guided biopsies</measure>
    <time_frame>Up to 5 months</time_frame>
    <description>Yield of nCLE (needle-based confocal laser endomicroscopy)-targeted Fluoroscopy-guided biopsies to assess improvements compared to standard of care from guidance function of the device combination.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of potential benefits of the device combination</measure>
    <time_frame>Up to 5 months</time_frame>
    <description>Potential clinical, operational and financial benefits of the combination of Mauna Kea Technologies' endomicroscopic solution and Siemens' C-arm solution derived from the improved decision making for treatment of lung and liver lesions during the procedure (a clinical benefit could be fewer negative biopsies; an operational benefit could be one step fewer in the care path and a financial benefit could be a quicker diagnosis/treatment time, thus being able to release the patient earlier).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of accuracy and predictive value of interpretation criteria</measure>
    <time_frame>Up to 5 months</time_frame>
    <description>Evaluation of the predictive value of Cellvizio as an increasing tool of biopsy performance.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">6</enrollment>
  <condition>Lung Percutaneous Biopsy</condition>
  <condition>Liver Percutaneous Biopsy</condition>
  <arm_group>
    <arm_group_label>addition of nCLE to help target biopsy</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>The patient, scheduled for a liver or lung CT-guided percutaneous biopsy or ablation will undergo a probe-based confocal laser endomicroscopy procedure after the imaging procedure. The objectives of this study are to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure and determine whether it is technically feasible to obtain images from Cellvizio during an interventional radiology procedure.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CT-guided percutaneous biopsy or ablation</intervention_name>
    <description>Standard interventional radiology procedure for a biopsy or ablation in the liver or in the lung</description>
    <arm_group_label>addition of nCLE to help target biopsy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients scheduled to have an interventional radiology procedure for needle-biopsy or&#xD;
             radiofrequency ablation purposes in lung or in liver, 18 years or older.&#xD;
&#xD;
          -  Only subjects who have provided written informed consent for the study can be included&#xD;
             in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Known allergy to fluorescein&#xD;
&#xD;
          -  Previous life-threatening allergic reactions and known hypersensitivity to contrast&#xD;
             media&#xD;
&#xD;
          -  Pregnancy or breast-feeding&#xD;
&#xD;
          -  History of cardio-pulmonary disease (including bronchial asthma)&#xD;
&#xD;
          -  Restricted renal function&#xD;
&#xD;
          -  Elderly with diabetes mellitus&#xD;
&#xD;
          -  Patients under a beta-blockers treatment&#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>Olivier PELLERIN</last_name>
    <role>Principal Investigator</role>
    <affiliation>HEGP, Paris, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Européen Georges Pompidou</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2016</verification_date>
  <study_first_submitted>July 28, 2014</study_first_submitted>
  <study_first_submitted_qc>August 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <last_update_submitted>April 26, 2016</last_update_submitted>
  <last_update_submitted_qc>April 26, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 27, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Interventional radiology</keyword>
  <keyword>Lung</keyword>
  <keyword>Liver</keyword>
  <keyword>Confocal endomicroscopy</keyword>
  <keyword>Optical biopsy</keyword>
  <keyword>Scanner</keyword>
  <keyword>Fluoroscopy</keyword>
  <keyword>CT</keyword>
  <keyword>Computed Tomography</keyword>
  <keyword>Radiofrequency Ablation</keyword>
  <keyword>Fluorescein</keyword>
  <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/NCT02224885
org study id: MKT-IR-HEGP-2014
nct id: NCT02224885
lead sponsor: 
has dmc: No
This study is a prospective study in order to demonstrate the technical feasibility and
      safety of doing endomicroscopic imaging during interventional radiology procedure in two main
      indications: lung and liver.

      This innovative study will involve the use of probe-based confocal laser endomicroscopy. The
      proposed study is a feasibility study.
Interventional radiology is a medical sub-specialty of radiology which utilizes
      minimally-invasive image-guided procedures to diagnose and treat diseases in nearly every
      organ. The concept behind interventional radiology is to diagnose and treat patients using
      less invasive techniques currently available in order to minimize risk to the patient and
      improve health outcomes.

      For many years, surgery was the only treatment available for many conditions. Today,
      interventional radiology treatments are frst-line care for a wide variety of conditions.
      Patients should be offered the least invasive option frst. It is important to get a second
      opinion and know all of your treatment options before consenting to any procedure or surgery.
      Interventional radiologists are specialists in minimally invasive treatments, have a unique
      breadth of training and provide consults to every type of specialist.

      Surgical removal of liver tumors offers the best chance for a cure. Unfortunately, liver
      tumors are often inoperable because the tumor may be too large, or has grown into major blood
      vessels or other vital structures. Sometimes, many small tumors are spread throughout the
      liver, making surgery too risky or impractical. Surgical removal is not possible for more
      than two-thirds of primary liver cancer patients and 90 percent of patients with secondary
      liver cancer.

      The objectives of this study are to demonstrate the technical feasibility and safety of doing
      endomicroscopic imaging during interventional radiology procedure in two main indications:
      lung and liver.

      The goal is to determine whether:

        -  Cellvizio insertion during the interventional procedure leads to change in known adverse
           events / serious adverse events rate during and one month after the procedure

        -  It is technically feasible to obtain images from Cellvizio during an interventional
           radiology procedure

        -  Cellvizio is a helpful assistance to increase the efficacy of biopsy which require to
           evaluate its accuracy eg. the predictive value of Cellvizio compared to pathology
           results.

      Secondary goals are to assess:

        -  Benefit of spatial accuracy for the yield of the biopsy procedure and potential
           subsequent intervention, e.g. radiofrequency ablation.

        -  Regarding lung biopsies and lung ablation, potential increase of a database to refine
           image interpretation criteria with pathologists.

        -  In liver application, the goal is to build a database of images and define image
           interpretation criteria with pathologists to start image interpretation work.

        -  The predictive value of biopsies with Cellvizio assistance for lung or liver tumor
           biopsies.

      For both applications, technical feedback from the physicians is expected on how they think
      the combined use of the devices could change the care path. E.g. a certain step in the
      workflow might become obsolete or the workflow could lead to fewer patient visits.

      For the safety of this protocol, the use of endomicroscopy will not change in any way the
      patient management and standard procedure, including the diagnosis nor treatment decisions.
      All the adverse events / serious adverse events will be noted during the procedure and one
      week after the procedure.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Measure adverse events frequency in the use of mini probes on the tumor
time frame: Up to 1 week
description: Assessment of the safety of inserting Cellvizio confocal miniprobe in the tumor (nor increase in bleeding or tumor cell dissemination) through the frequency, type and severity of adverse events
measure: Creation of image bank
time frame: Up to 6 months
description: A frst creation of an atlas of endomicroscopic images obtained in interventional radiology in the liver - for the lung, the atlas established for peripheral lung nodules in bronchoscopy applications will serve as a reference and will be tested prospectively.
measure: Yield of nCLE (needle-based confocal laser endomicroscopy)-targeted Fluoroscopy-guided biopsies
time frame: Up to 5 months
description: Yield of nCLE (needle-based confocal laser endomicroscopy)-targeted Fluoroscopy-guided biopsies to assess improvements compared to standard of care from guidance function of the device combination.
measure: Evaluation of potential benefits of the device combination
time frame: Up to 5 months
description: Potential clinical, operational and financial benefits of the combination of Mauna Kea Technologies' endomicroscopic solution and Siemens' C-arm solution derived from the improved decision making for treatment of lung and liver lesions during the procedure (a clinical benefit could be fewer negative biopsies; an operational benefit could be one step fewer in the care path and a financial benefit could be a quicker diagnosis/treatment time, thus being able to release the patient earlier).
measure: Assessment of accuracy and predictive value of interpretation criteria
time frame: Up to 5 months
description: Evaluation of the predictive value of Cellvizio as an increasing tool of biopsy performance.
arm group label: addition of nCLE to help target biopsy
arm group type: Other
description: The patient, scheduled for a liver or lung CT-guided percutaneous biopsy or ablation will undergo a probe-based confocal laser endomicroscopy procedure after the imaging procedure. The objectives of this study are to demonstrate the technical feasibility and safety of doing endomicroscopic imaging during interventional radiology procedure and determine whether it is technically feasible to obtain images from Cellvizio during an interventional radiology procedure.
intervention type: Device
intervention name: CT-guided percutaneous biopsy or ablation
description: Standard interventional radiology procedure for a biopsy or ablation in the liver or in the lung
arm group label: addition of nCLE to help target biopsy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Olivier PELLERIN
role: Principal Investigator
affiliation: HEGP, Paris, France
facility: 
country: France
responsible party type: Sponsor
sharing ipd: No