<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/NCT01681797</url>
  </required_header>
  <id_info>
    <org_study_id>DCIC/11/13</org_study_id>
    <nct_id>NCT01681797</nct_id>
  </id_info>
  <brief_title>Fluorescence Angiography: Planning and Monitoring of Perforator Flaps</brief_title>
  <acronym>AFLU</acronym>
  <official_title>Fluorescence Angiography With Fluobeam™ Camera (Fluoptics Company): Planning and Monitoring of Perforator Flaps</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine whether fluorescence angiography is an&#xD;
      effectiveness technique for the localization of vascular perforators and their area of&#xD;
      perfusion and for the postoperative monitoring of flap perfusion.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reconstructive surgery is intended to replace amputated anatomical regions by autologous&#xD;
      tissue taken from distant locations: flaps. The goal is to restitute ad integrum with minimal&#xD;
      sequelae. Among the flaps available, perforator flaps have the advantage of being highly&#xD;
      plastic, large and can be taken from accessory vessels the loss of wich does not compromise&#xD;
      the vitality of the sampling site. However their more variable anatomy requires irradiating&#xD;
      preoperative morphological assessment (CT angiography) or a doppler ultrasonography that is&#xD;
      not always performed by the surgeon himself and does not distinguish between muscle&#xD;
      perforator and skin perforator.&#xD;
&#xD;
      Fluorescence angiography is a superficial exploration technique of vascularization. After&#xD;
      intravenous injection of a tracer (indocyanine green ICG), fluorescence angiography provides&#xD;
      useful surface angiographic imaging in real-time. It can also help in monitoring&#xD;
      intraoperative and postoperative quality of vascular anastomoses. Although fluorescence&#xD;
      angiography has numerous applications (ophthalmology, neurosurgery, liver&#xD;
      transplantation...), its usefulness in surgical flaps is only supported by a few&#xD;
      publications. None really validate its clinical value by comparing it to reference&#xD;
      investigations (CT angiography or doppler ultrasonography).&#xD;
&#xD;
      40 candidate for reconstructive surgery will be included in this study. The day before&#xD;
      surgery, in addition to the usual technique used to locate perforator flaps, the patient will&#xD;
      receive an injection of 0.025 mg / kg Infracyanine® (indocyanine green) and the area of&#xD;
      interest of the flap will be explored with the Fluobeam™ camera.&#xD;
&#xD;
      Two hours after the surgery, during the usual clinical monitoring of the vitality of the&#xD;
      flap, a new injection of Infracyanine® will test perfusion of the flap by measuring&#xD;
      fluorescence intensity of the target area. These measurement will then be repeated every 6&#xD;
      hours for 4 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    The study was stopped due to lack of inclusion&#xD;
  </why_stopped>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">October 10, 2015</completion_date>
  <primary_completion_date type="Actual">October 10, 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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Comparison between the position of perforator flap determined by fluorescence angiography and the real anatomic position of the flap determined after dissection</measure>
    <time_frame>During the first fluorescent angiography</time_frame>
    <description>For each flap, the position of the flap determined by fluorescent angiography will be compared with the anatomic position (actual) determined on the relevant flap after dissection (gold standard).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Comparison between the position of the perforator flap determined by fluorescence angiography and the position of the flap determined by reference imaging techniques relevant to the flap (CT angiography or doppler ultrasonography)</measure>
    <time_frame>During the first fluorescent angiography</time_frame>
    <description>For each flap, the position of the flap determined by fluorescent angiography will be compared with the position determined by reference imaging techniques relevant to the flap (CT angiography or doppler ultrasonography)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative monitoring of the quality of micro-vascular anastomoses using fluorescent angiography</measure>
    <time_frame>Just after micro-vascular anastomoses</time_frame>
    <description>Intraoperative monitoring of vascular flow through the micro-anastomoses will be determined by:&#xD;
measuring the arterial and venous trans-anastomotic flow (ml / mm)&#xD;
flow measurement (ml / mm) of an equivalent diameter vessel located in the operative field and not affected by the anastomosis&#xD;
intrinsic transit time (in seconds) which is the time required for the fluorescence between the arterial anastomosis and the venous anastomosis&#xD;
the number of leaks around the anastomosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative monitoring of flap perfusion using fluorescence angiography</measure>
    <time_frame>Every six hours for four days after surgery</time_frame>
    <description>This is to test the hypothesis that the dynamics of the fluorescence intensity in the area of interest is a prognostic factor for postoperative complications.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Reconstructive Surgery</condition>
  <arm_group>
    <arm_group_label>add-on fluorescence angiography</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The surgeon will prescribe the usual morphological assessment of the proposed flap:&#xD;
CT angiography for an anterolateral thigh flap or an epigastric inferior flap&#xD;
A Doppler ultrasonography for a fibula flap.&#xD;
In addition to the usual radiological technique used to locate the perforating arteries, the patient will have a fluorescence angiography prior to surgery, another just after the end of surgery and then one every six hours during the next 4 days.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company)</intervention_name>
    <description>Fluorescence angiography after intravenous injection of Infracyanine® (indocyanine green)</description>
    <arm_group_label>add-on fluorescence angiography</arm_group_label>
    <other_name>The device used in this study is the Fluobeam™ imaging system developed by the company Fluoptics.</other_name>
    <other_name>the technique requires the injection of a tracer Infracyanine® (SERB pharmaceutical company)</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  perforator flap reconstruction whatever the indication (cancer, trauma,&#xD;
             malformations). The main targets are the fibula flaps, anterolateral thigh flaps and&#xD;
             inferior epigastric flaps&#xD;
&#xD;
          -  consenting patient&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  known indocyanine green allergy&#xD;
&#xD;
          -  pregnant woman, parturient woman or nursing woman&#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>Georges BETTEGA, MD, PHD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Grenoble</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Hospital of Grenoble</name>
      <address>
        <city>Grenoble</city>
        <state>Isere</state>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Koenig A, Herve L, Gonon G, Josserand V, Berger M, Dinten JM, Boutet J, Peltie P, Coll JL, Rizo P. Fluorescence diffuse optical tomography for free-space and multifluorophore studies. J Biomed Opt. 2010 Jan-Feb;15(1):016016. doi: 10.1117/1.3309738.</citation>
    <PMID>20210462</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 31, 2012</study_first_submitted>
  <study_first_submitted_qc>September 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 10, 2012</study_first_posted>
  <last_update_submitted>April 16, 2019</last_update_submitted>
  <last_update_submitted_qc>April 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>fluorescent angiography</keyword>
  <keyword>reconstructive surgery</keyword>
  <keyword>perforator flap</keyword>
  <!-- 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/NCT01681797
org study id: DCIC/11/13
nct id: NCT01681797
lead sponsor: 
has dmc: Yes
The purpose of this study is to determine whether fluorescence angiography is an
      effectiveness technique for the localization of vascular perforators and their area of
      perfusion and for the postoperative monitoring of flap perfusion.
Reconstructive surgery is intended to replace amputated anatomical regions by autologous
      tissue taken from distant locations: flaps. The goal is to restitute ad integrum with minimal
      sequelae. Among the flaps available, perforator flaps have the advantage of being highly
      plastic, large and can be taken from accessory vessels the loss of wich does not compromise
      the vitality of the sampling site. However their more variable anatomy requires irradiating
      preoperative morphological assessment (CT angiography) or a doppler ultrasonography that is
      not always performed by the surgeon himself and does not distinguish between muscle
      perforator and skin perforator.

      Fluorescence angiography is a superficial exploration technique of vascularization. After
      intravenous injection of a tracer (indocyanine green ICG), fluorescence angiography provides
      useful surface angiographic imaging in real-time. It can also help in monitoring
      intraoperative and postoperative quality of vascular anastomoses. Although fluorescence
      angiography has numerous applications (ophthalmology, neurosurgery, liver
      transplantation...), its usefulness in surgical flaps is only supported by a few
      publications. None really validate its clinical value by comparing it to reference
      investigations (CT angiography or doppler ultrasonography).

      40 candidate for reconstructive surgery will be included in this study. The day before
      surgery, in addition to the usual technique used to locate perforator flaps, the patient will
      receive an injection of 0.025 mg / kg Infracyanine® (indocyanine green) and the area of
      interest of the flap will be explored with the Fluobeam™ camera.

      Two hours after the surgery, during the usual clinical monitoring of the vitality of the
      flap, a new injection of Infracyanine® will test perfusion of the flap by measuring
      fluorescence intensity of the target area. These measurement will then be repeated every 6
      hours for 4 days.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Other
masking: None (Open Label)
measure: Comparison between the position of perforator flap determined by fluorescence angiography and the real anatomic position of the flap determined after dissection
time frame: During the first fluorescent angiography
description: For each flap, the position of the flap determined by fluorescent angiography will be compared with the anatomic position (actual) determined on the relevant flap after dissection (gold standard).
measure: Comparison between the position of the perforator flap determined by fluorescence angiography and the position of the flap determined by reference imaging techniques relevant to the flap (CT angiography or doppler ultrasonography)
time frame: During the first fluorescent angiography
description: For each flap, the position of the flap determined by fluorescent angiography will be compared with the position determined by reference imaging techniques relevant to the flap (CT angiography or doppler ultrasonography)
measure: Intraoperative monitoring of the quality of micro-vascular anastomoses using fluorescent angiography
time frame: Just after micro-vascular anastomoses
description: Intraoperative monitoring of vascular flow through the micro-anastomoses will be determined by:
measuring the arterial and venous trans-anastomotic flow (ml / mm)
flow measurement (ml / mm) of an equivalent diameter vessel located in the operative field and not affected by the anastomosis
intrinsic transit time (in seconds) which is the time required for the fluorescence between the arterial anastomosis and the venous anastomosis
the number of leaks around the anastomosis.
measure: Postoperative monitoring of flap perfusion using fluorescence angiography
time frame: Every six hours for four days after surgery
description: This is to test the hypothesis that the dynamics of the fluorescence intensity in the area of interest is a prognostic factor for postoperative complications.
arm group label: add-on fluorescence angiography
arm group type: Experimental
description: The surgeon will prescribe the usual morphological assessment of the proposed flap:
CT angiography for an anterolateral thigh flap or an epigastric inferior flap
A Doppler ultrasonography for a fibula flap.
In addition to the usual radiological technique used to locate the perforating arteries, the patient will have a fluorescence angiography prior to surgery, another just after the end of surgery and then one every six hours during the next 4 days.
intervention type: Device
intervention name: Fluorescence angiography (Fluobeam™ imaging system developed by Fluoptics company)
description: Fluorescence angiography after intravenous injection of Infracyanine® (indocyanine green)
arm group label: add-on fluorescence angiography
other name: The device used in this study is the Fluobeam™ imaging system developed by the company Fluoptics.
other name: the technique requires the injection of a tracer Infracyanine® (SERB pharmaceutical company)
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Georges BETTEGA, MD, PHD
role: Principal Investigator
affiliation: University Hospital, Grenoble
facility: 
country: France
citation: Koenig A, Herve L, Gonon G, Josserand V, Berger M, Dinten JM, Boutet J, Peltie P, Coll JL, Rizo P. Fluorescence diffuse optical tomography for free-space and multifluorophore studies. J Biomed Opt. 2010 Jan-Feb;15(1):016016. doi: 10.1117/1.3309738.
PMID: 20210462
responsible party type: Sponsor