<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/NCT03283423</url>
  </required_header>
  <id_info>
    <org_study_id>2016P002535</org_study_id>
    <nct_id>NCT03283423</nct_id>
  </id_info>
  <brief_title>Image-guided Lymphadanectomy in AMIGO</brief_title>
  <official_title>Image-guided Lymphadanectomy in AMIGO</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Brigham and Women's Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Siemens Corporation, Corporate Technology</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>KARL STORZ Endoscopy-America, Inc.</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Brigham and Women's Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To perform image-guided laparoscopic intra-abdominal lymph node biopsy with goal of&#xD;
      minimizing surgical risk and improving accuracy of biopsy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Only the superficial lymph nodes are accessible to physical examination, and assessment of&#xD;
      deeper nodes, such as those in the abdomen, requires radiological imaging. As a result,&#xD;
      abdominal CT and PET scanning of patients with a history of malignancy or concerns for a new&#xD;
      diagnosis of cancer is an important diagnostic test. As well as looking for distant&#xD;
      metastasis, the images are carefully assessed for evidence of intra-abdominal&#xD;
      lymphadenopathy, which can be a marker of new or recurrent cancer. If such nodes are&#xD;
      identified, they often require a biopsy for further evaluation.&#xD;
&#xD;
      The lymph nodes located in the abdomen or the retroperitoneum are not easily accessible for&#xD;
      percutaneous biopsy, often requiring an abdominal exploration which can be done either&#xD;
      laparoscopically or via laparotomy. The laparoscopic approach represents a better approach&#xD;
      that is associated with reduced surgical risks and complications as well as a quicker&#xD;
      recover. In fact in many cases, the laparoscopic approach can be done as a day surgery&#xD;
      procedure.&#xD;
&#xD;
      Although non-invasive imaging technologies such as computed tomography (CT) scanning,&#xD;
      magnetic resonance imaging (MRI), and positron emission tomography (PET) scanning can be&#xD;
      useful in the diagnosis of lymphadenopathy, they often provide an estimate of the location of&#xD;
      the nodes, and exact localization of the lymph node of interest can be challenging. The&#xD;
      surgeons rely on anatomical landmarks which can be distorted during laparoscopy and to help&#xD;
      reduce the rate of false negative lymph node biopsy, the surgeons often perform&#xD;
      intra-operative histological assessment of the lymph nodes (Frozen Section) which can be time&#xD;
      consuming and in itself associated with diagnostic errors. The uncertainty about the exact&#xD;
      location of the node of interest often leads to extensive surgical dissection, biopsy of&#xD;
      multiple nodes, and sometimes repeat surgery. During the dissection, care must be taken to&#xD;
      avoid injury to the neighboring structures, such as blood vessels, nerves or adjacent organs.&#xD;
      In cases, where an intra-operative dissection occurs, or lymph nodes can not be identified,&#xD;
      the laparoscopic surgery is converted to open surgery.&#xD;
&#xD;
      Using the unique capabilities of the AMIGO suite, investigators aim to test intra-operative&#xD;
      image guidance to help them identify diseased intra-abdominal lymph nodes, allowing for more&#xD;
      precise and safer surgeries. The improved accuracy will allow investigators to perform&#xD;
      surgeries with minimal dissection and reduced complications while improving biopsy rates and&#xD;
      enhancing ability to accurately stage intra-abdominal malignancies.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 2017</start_date>
  <completion_date type="Anticipated">March 2019</completion_date>
  <primary_completion_date type="Anticipated">January 2019</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of lymph node biopsy</measure>
    <time_frame>through study completion, an average of 1 year</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Lymphadenopathy Retroperitoneal</condition>
  <condition>Lymphoma</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Image-guided Lymphadanectomy in AMIGO</intervention_name>
    <description>Image guided laparoscopic lymph node biopsy</description>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Signed written informed consent before any trial related procedure is undertaken that&#xD;
             is not part of the standard patient management&#xD;
&#xD;
          -  Subjects aged ≥ 18 years. Selected patients must have a confirmed or suspected&#xD;
             diagnosis of disease in the abdomen or retroperitoneum, with scheduled confirmatory&#xD;
             surgical biopsy.&#xD;
&#xD;
          -  Subjects must have had a CT, PET examination or MR examination of acceptable quality&#xD;
             at Brigham and Women's Hospital within the prior month&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Severely impaired renal function with an EGFR &lt; 30 mL/min/body surface area&#xD;
&#xD;
          -  Evidence of any significant, uncontrolled comorbid condition that could affect&#xD;
             compliance with the protocol or interpretation of the results, which is to be judged&#xD;
             at the discretion of the PI&#xD;
&#xD;
          -  History of hypersensitivity or other contraindication to contrast media&#xD;
&#xD;
          -  Contraindication to general anesthesia&#xD;
&#xD;
          -  Pregnancy&#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>Ali Tavakkoli, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brigham and Women's Hopistal</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ali Tavakkoli, MD</last_name>
    <phone>6177326337</phone>
    <email>atavakkoli@bwh.harvard.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jayender Jagadeesen, PhD</last_name>
    <phone>617-278-0986</phone>
    <email>jayender@bwh.harvard.edu</email>
  </overall_contact_backup>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>September 11, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 14, 2017</study_first_posted>
  <last_update_submitted>September 12, 2017</last_update_submitted>
  <last_update_submitted_qc>September 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Brigham and Women's Hospital</investigator_affiliation>
    <investigator_full_name>Ali Tavakkoli</investigator_full_name>
    <investigator_title>Associate Surgeon</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lymphadenopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03283423
org study id: 2016P002535
nct id: NCT03283423
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
To perform image-guided laparoscopic intra-abdominal lymph node biopsy with goal of
      minimizing surgical risk and improving accuracy of biopsy.
Only the superficial lymph nodes are accessible to physical examination, and assessment of
      deeper nodes, such as those in the abdomen, requires radiological imaging. As a result,
      abdominal CT and PET scanning of patients with a history of malignancy or concerns for a new
      diagnosis of cancer is an important diagnostic test. As well as looking for distant
      metastasis, the images are carefully assessed for evidence of intra-abdominal
      lymphadenopathy, which can be a marker of new or recurrent cancer. If such nodes are
      identified, they often require a biopsy for further evaluation.

      The lymph nodes located in the abdomen or the retroperitoneum are not easily accessible for
      percutaneous biopsy, often requiring an abdominal exploration which can be done either
      laparoscopically or via laparotomy. The laparoscopic approach represents a better approach
      that is associated with reduced surgical risks and complications as well as a quicker
      recover. In fact in many cases, the laparoscopic approach can be done as a day surgery
      procedure.

      Although non-invasive imaging technologies such as computed tomography (CT) scanning,
      magnetic resonance imaging (MRI), and positron emission tomography (PET) scanning can be
      useful in the diagnosis of lymphadenopathy, they often provide an estimate of the location of
      the nodes, and exact localization of the lymph node of interest can be challenging. The
      surgeons rely on anatomical landmarks which can be distorted during laparoscopy and to help
      reduce the rate of false negative lymph node biopsy, the surgeons often perform
      intra-operative histological assessment of the lymph nodes (Frozen Section) which can be time
      consuming and in itself associated with diagnostic errors. The uncertainty about the exact
      location of the node of interest often leads to extensive surgical dissection, biopsy of
      multiple nodes, and sometimes repeat surgery. During the dissection, care must be taken to
      avoid injury to the neighboring structures, such as blood vessels, nerves or adjacent organs.
      In cases, where an intra-operative dissection occurs, or lymph nodes can not be identified,
      the laparoscopic surgery is converted to open surgery.

      Using the unique capabilities of the AMIGO suite, investigators aim to test intra-operative
      image guidance to help them identify diseased intra-abdominal lymph nodes, allowing for more
      precise and safer surgeries. The improved accuracy will allow investigators to perform
      surgeries with minimal dissection and reduced complications while improving biopsy rates and
      enhancing ability to accurately stage intra-abdominal malignancies.
allocation: Non-Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Accuracy of lymph node biopsy
time frame: through study completion, an average of 1 year
intervention type: Device
intervention name: Image-guided Lymphadanectomy in AMIGO
description: Image guided laparoscopic lymph node biopsy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ali Tavakkoli, MD
role: Principal Investigator
affiliation: Brigham and Women's Hopistal
last name: Ali Tavakkoli, MD
phone: 6177326337
email: atavakkoli@bwh.harvard.edu
last name: Jayender Jagadeesen, PhD
phone: 617-278-0986
email: jayender@bwh.harvard.edu
responsible party type: Principal Investigator
investigator affiliation: Brigham and Women's Hospital
investigator full name: Ali Tavakkoli
investigator title: Associate Surgeon
mesh term: Lymphadenopathy
sharing ipd: Undecided