<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/NCT03021200</url>
  </required_header>
  <id_info>
    <org_study_id>NP953/16</org_study_id>
    <nct_id>NCT03021200</nct_id>
  </id_info>
  <brief_title>Laser Fluorescence in Cancer Surgical Treatment</brief_title>
  <official_title>Use of Laser Fluorescence With Spy Elite, Pinpoint and Firefly Robotic Platform Systems in Cancer Surgical Treatment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Instituto do Cancer do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, Brazil</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Fundação Faculdade de Medicina</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Instituto do Cancer do Estado de São Paulo</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The use of fluorescence for real-time evaluation of organ and tissue vascularization and&#xD;
      lymph node anatomy is a recent technology with potential for the surgical treatment of&#xD;
      cancer. The real-time analysis of tissue vascularization allows immediate identification to&#xD;
      the surgeon of areas with greater or lesser blood circulation, favoring surgical decision&#xD;
      making and prevention of complications related to tissue ischemia (necrosis, dehiscences and&#xD;
      infections). It is a technology with potential application in the areas of Digestive Surgery,&#xD;
      Repairing Plastic Surgery in Oncology, Head and Neck Surgery. In addition, fluorescence can&#xD;
      be used as a method to identify lymph node structures of interest in the oncological&#xD;
      treatment of patients with urologic, gynecological and digestive tumors.&#xD;
&#xD;
      Introduced by Pestana et al. In the late 2000s, the perfusion mapping system through&#xD;
      intraoperative indocyanine assisted laser angiography (SPY Elite System © LifeCell Corp.,&#xD;
      Branchburg, N.J.) had its initial application in repairing surgery after breast cancer&#xD;
      treatment. The method proved to be useful in the prevention of ischemic and infectious&#xD;
      complications in cancer surgery. Pestana, in a prospective clinical series of 29&#xD;
      microsurgical flaps used in several reconstructions, observed a single case of partial loss&#xD;
      of the flap, the present technology having a relevant role in intraoperative decision making.&#xD;
      In the same year, Newman et al. The first application of the system in breast reconstruction&#xD;
      surgery. In an initial series of 10 consecutive cases of reconstruction with microsurgical&#xD;
      flaps, in 4 cases the system allowed the intraoperative identification of areas of low&#xD;
      perfusion, thus changing the surgical procedure. According to the authors, there was a 95%&#xD;
      correlation between indocyanine laser assisted and subsequent development of mastectomy skin&#xD;
      necrosis, with sensitivity of 100% and specificity of 91%. Similarly, Murray et al. Evaluated&#xD;
      the intraoperative perfusion, however, of the areola-papillary complex in patients submitted&#xD;
      to subcutaneous mastectomies with satisfactory results in terms of predictability of&#xD;
      cutaneous circulation. Other authors in larger clinical series and evaluating other&#xD;
      procedures have observed valid results in terms of prevention of complications.&#xD;
&#xD;
      Vascular perfusion of anastomoses and fistulas following bowel surgery for cancer remain a&#xD;
      serious and common complication. These fistulas can be caused by insufficient perfusion of&#xD;
      the intestinal anastomosis. Intraoperative angiography with indocyanine assisted laser can be&#xD;
      used to visualize the blood perfusion following intravenous injection of the indocyanine&#xD;
      green contrast. Several groups reported the ability to assess blood perfusion of the&#xD;
      anastomotic area after bowel surgery. Although they studied retrospectively, Kudszus and&#xD;
      colleagues described a reduction in the risk of revision due to fistula in 60% of patients&#xD;
      whose anastomosis was examined using laser fluorescence angiography compared to historically&#xD;
      paired patients without this method. The same principle can be used to evaluate the tubulized&#xD;
      stomach to be transposed to the cervical region after subtotal esophagectomy.&#xD;
&#xD;
      Currently, fluorescence-guided sentinel lymph node mapping has been studied in breast cancer&#xD;
      as well as investigative character in colorectal cancer, skin cancer, cervical cancer, vulvar&#xD;
      cancer, head and neck, lung cancer, penile cancer, cancer Endometrial cancer, gastric cancer&#xD;
      and esophageal cancer.&#xD;
&#xD;
      These early studies demonstrated the feasibility of this methodology during surgery.&#xD;
      Comparison of laser fluorescence images on blue dyes indicate that fluorescence images can&#xD;
      replace blue dyes because they exceed them due to increased tissue penetration depth and&#xD;
      absence of staining in the patient and cleaning of the operative field.&#xD;
&#xD;
      To date, there are no clinical studies involving intraoperative perfusion mapping and&#xD;
      identification of lymph node structures with the SPY Elite System © system or other platforms&#xD;
      (Pinpoint or Firefly) in Brazil that evaluate the Brazilian population. In an objective way&#xD;
      the influence of this technology as predictive in the better or worse evolution of the&#xD;
      oncologic surgery as well as in the prevention of the local ischemic complications by means&#xD;
      of intraopeal change of conduct&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 12, 2016</start_date>
  <completion_date type="Anticipated">December 10, 2020</completion_date>
  <primary_completion_date type="Actual">October 12, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intestinal Anastomosis Fistula</measure>
    <time_frame>3 years</time_frame>
    <description>Intestinal Anastomosis Fistula Rate in oncologic resection of intestinal tumors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Esophageal fistula</measure>
    <time_frame>3 years</time_frame>
    <description>Esophageal reconstruction fistula rate in esophagectomies</description>
  </primary_outcome>
  <primary_outcome>
    <measure>positive lymph nodes</measure>
    <time_frame>3 years</time_frame>
    <description>The number of fluorescence-positive lymph nodes per patient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>lymph nodes detected by pathology</measure>
    <time_frame>3 years</time_frame>
    <description>The number of lymph nodes detected by pathology per patient</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mastectomy Skin Necrosis</measure>
    <time_frame>3 years</time_frame>
    <description>Mastectomy Skin Necrosis Rate in Breast Reconstructions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Breast Implant Extrusion</measure>
    <time_frame>3 years</time_frame>
    <description>Breast Implant Extrusion Rate in Breast Reconstructions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Surgical Site Infection in Breast Reconstructions</measure>
    <time_frame>3 years</time_frame>
    <description>Surgical Site Infection Rate in Breast Reconstructions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Skin Necrosis in Head and Neck Reconstruction</measure>
    <time_frame>3 years</time_frame>
    <description>Skin Necrosis Rate in Supraclavicular snip in Head and Neck Reconstruction</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">270</enrollment>
  <condition>Esophageal Cancer</condition>
  <condition>Gastric Cancer</condition>
  <condition>ColoRectal Cancer</condition>
  <condition>Prostatic Neoplasms</condition>
  <condition>Uterine Cancer</condition>
  <condition>Head and Neck Cancer</condition>
  <condition>Breast Neoplasm</condition>
  <arm_group>
    <arm_group_label>Indocyanine green in Conventional Oncological Surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (SPY-Elite) for conventional oncological surgeries</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indocyanine green in minimally invasive Oncological Surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Pinpoint) for minimally invasive oncological surgeries</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Indocyanine green in robot-assisted Oncological Surgery</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Firefly) for robot-assisted oncological surgeries</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Green indocianine</intervention_name>
    <description>Laser fluorescence using green indocianine guiding the surgical procedure.</description>
    <arm_group_label>Indocyanine green in Conventional Oncological Surgery</arm_group_label>
    <arm_group_label>Indocyanine green in minimally invasive Oncological Surgery</arm_group_label>
    <arm_group_label>Indocyanine green in robot-assisted Oncological Surgery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with cancer and indication for one of the following surgeries:&#xD;
&#xD;
          -  Low Anterior Resection&#xD;
&#xD;
          -  Esophagectomy&#xD;
&#xD;
          -  Lymphadenectomy&#xD;
&#xD;
          -  Prostatectomy&#xD;
&#xD;
          -  Pelvic or paraortic lymphadenectomy&#xD;
&#xD;
          -  Surgery of head and neck with indication of supraclavicular flap&#xD;
&#xD;
          -  Mastectomy followed by immediate or late breast reconstruction&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a history of adverse reaction or known allergy to contrast, or iodine&#xD;
             tinctures;&#xD;
&#xD;
          -  Pregnant or lactating women.&#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>Ulysses Ribeiro, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto do Cancer do Estado de Sao Paulo</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ulysses Ribeiro, MD</last_name>
    <phone>55 11 3893-2574</phone>
    <email>ulysses.ribeiro@fm.usp.br</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Evelise P Zaidan</last_name>
    <phone>55 11 3893-3546</phone>
    <email>evelize.zaidan@hc.fm.usp.br</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Ulysses Ribeiro Junior</name>
      <address>
        <city>Sao Paulo</city>
        <state>São Paulo</state>
        <zip>01246-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Evelise P Zaidan</last_name>
      <phone>55 11 38933546</phone>
      <email>evelise.zaidan@hc.usp.br</email>
    </contact>
    <investigator>
      <last_name>Marcus FKP Ramos, MD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>November 8, 2019</last_update_submitted>
  <last_update_submitted_qc>November 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 12, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neoplasms</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Prostatic Neoplasms</mesh_term>
    <mesh_term>Uterine 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/NCT03021200
org study id: NP953/16
nct id: NCT03021200
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
The use of fluorescence for real-time evaluation of organ and tissue vascularization and
      lymph node anatomy is a recent technology with potential for the surgical treatment of
      cancer. The real-time analysis of tissue vascularization allows immediate identification to
      the surgeon of areas with greater or lesser blood circulation, favoring surgical decision
      making and prevention of complications related to tissue ischemia (necrosis, dehiscences and
      infections). It is a technology with potential application in the areas of Digestive Surgery,
      Repairing Plastic Surgery in Oncology, Head and Neck Surgery. In addition, fluorescence can
      be used as a method to identify lymph node structures of interest in the oncological
      treatment of patients with urologic, gynecological and digestive tumors.

      Introduced by Pestana et al. In the late 2000s, the perfusion mapping system through
      intraoperative indocyanine assisted laser angiography (SPY Elite System © LifeCell Corp.,
      Branchburg, N.J.) had its initial application in repairing surgery after breast cancer
      treatment. The method proved to be useful in the prevention of ischemic and infectious
      complications in cancer surgery. Pestana, in a prospective clinical series of 29
      microsurgical flaps used in several reconstructions, observed a single case of partial loss
      of the flap, the present technology having a relevant role in intraoperative decision making.
      In the same year, Newman et al. The first application of the system in breast reconstruction
      surgery. In an initial series of 10 consecutive cases of reconstruction with microsurgical
      flaps, in 4 cases the system allowed the intraoperative identification of areas of low
      perfusion, thus changing the surgical procedure. According to the authors, there was a 95%
      correlation between indocyanine laser assisted and subsequent development of mastectomy skin
      necrosis, with sensitivity of 100% and specificity of 91%. Similarly, Murray et al. Evaluated
      the intraoperative perfusion, however, of the areola-papillary complex in patients submitted
      to subcutaneous mastectomies with satisfactory results in terms of predictability of
      cutaneous circulation. Other authors in larger clinical series and evaluating other
      procedures have observed valid results in terms of prevention of complications.

      Vascular perfusion of anastomoses and fistulas following bowel surgery for cancer remain a
      serious and common complication. These fistulas can be caused by insufficient perfusion of
      the intestinal anastomosis. Intraoperative angiography with indocyanine assisted laser can be
      used to visualize the blood perfusion following intravenous injection of the indocyanine
      green contrast. Several groups reported the ability to assess blood perfusion of the
      anastomotic area after bowel surgery. Although they studied retrospectively, Kudszus and
      colleagues described a reduction in the risk of revision due to fistula in 60% of patients
      whose anastomosis was examined using laser fluorescence angiography compared to historically
      paired patients without this method. The same principle can be used to evaluate the tubulized
      stomach to be transposed to the cervical region after subtotal esophagectomy.

      Currently, fluorescence-guided sentinel lymph node mapping has been studied in breast cancer
      as well as investigative character in colorectal cancer, skin cancer, cervical cancer, vulvar
      cancer, head and neck, lung cancer, penile cancer, cancer Endometrial cancer, gastric cancer
      and esophageal cancer.

      These early studies demonstrated the feasibility of this methodology during surgery.
      Comparison of laser fluorescence images on blue dyes indicate that fluorescence images can
      replace blue dyes because they exceed them due to increased tissue penetration depth and
      absence of staining in the patient and cleaning of the operative field.

      To date, there are no clinical studies involving intraoperative perfusion mapping and
      identification of lymph node structures with the SPY Elite System © system or other platforms
      (Pinpoint or Firefly) in Brazil that evaluate the Brazilian population. In an objective way
      the influence of this technology as predictive in the better or worse evolution of the
      oncologic surgery as well as in the prevention of the local ischemic complications by means
      of intraopeal change of conduct
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Intestinal Anastomosis Fistula
time frame: 3 years
description: Intestinal Anastomosis Fistula Rate in oncologic resection of intestinal tumors
measure: Esophageal fistula
time frame: 3 years
description: Esophageal reconstruction fistula rate in esophagectomies
measure: positive lymph nodes
time frame: 3 years
description: The number of fluorescence-positive lymph nodes per patient
measure: lymph nodes detected by pathology
time frame: 3 years
description: The number of lymph nodes detected by pathology per patient
measure: Mastectomy Skin Necrosis
time frame: 3 years
description: Mastectomy Skin Necrosis Rate in Breast Reconstructions
measure: Breast Implant Extrusion
time frame: 3 years
description: Breast Implant Extrusion Rate in Breast Reconstructions
measure: Surgical Site Infection in Breast Reconstructions
time frame: 3 years
description: Surgical Site Infection Rate in Breast Reconstructions
measure: Skin Necrosis in Head and Neck Reconstruction
time frame: 3 years
description: Skin Necrosis Rate in Supraclavicular snip in Head and Neck Reconstruction
arm group label: Indocyanine green in Conventional Oncological Surgery
arm group type: Experimental
description: Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (SPY-Elite) for conventional oncological surgeries
arm group label: Indocyanine green in minimally invasive Oncological Surgery
arm group type: Experimental
description: Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Pinpoint) for minimally invasive oncological surgeries
arm group label: Indocyanine green in robot-assisted Oncological Surgery
arm group type: Experimental
description: Use of indocyanine green laser fluorescence angiography (AFLIICG) platforms (Firefly) for robot-assisted oncological surgeries
intervention type: Device
intervention name: Green indocianine
description: Laser fluorescence using green indocianine guiding the surgical procedure.
arm group label: Indocyanine green in Conventional Oncological Surgery
arm group label: Indocyanine green in minimally invasive Oncological Surgery
arm group label: Indocyanine green in robot-assisted Oncological Surgery
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ulysses Ribeiro, MD
role: Principal Investigator
affiliation: Instituto do Cancer do Estado de Sao Paulo
last name: Ulysses Ribeiro, MD
phone: 55 11 3893-2574
email: ulysses.ribeiro@fm.usp.br
last name: Evelise P Zaidan
phone: 55 11 3893-3546
email: evelize.zaidan@hc.fm.usp.br
facility: 
status: Recruiting
contact: 
investigator: 
country: Brazil
responsible party type: Sponsor
mesh term: Neoplasms
mesh term: Breast Neoplasms
mesh term: Prostatic Neoplasms
mesh term: Uterine Neoplasms
sharing ipd: No