<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/NCT01729832</url>
  </required_header>
  <id_info>
    <org_study_id>OSU-10106</org_study_id>
    <secondary_id>NCI-2012-00693</secondary_id>
    <nct_id>NCT01729832</nct_id>
  </id_info>
  <brief_title>Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer</brief_title>
  <official_title>Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ohio State University Comprehensive Cancer Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ohio State University Comprehensive Cancer Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Many hospitals, including the Ohio State University Medical Center, will take pictures of the&#xD;
      blood vessels in a patient's abdomen before they decide to perform a breast reconstruction&#xD;
      using the patient's own tissue. These pictures are called computed tomography (CT) angiograms&#xD;
      and are like a map of each patient's anatomy. However, no study has been reported that&#xD;
      determined how accurate these pictures are at showing the surgeon where all of the blood&#xD;
      vessels were located. This study will try to determine if these pictures are missing any&#xD;
      blood vessels that are found during surgery and if the pictures show the correct location of&#xD;
      the vessels&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PRIMARY OBJECTIVES:&#xD;
&#xD;
      I. To analyze the accuracy of preoperative CT angiography in determining the location of&#xD;
      perforator vessels. Through the use of an intraoperative navigation system, we will&#xD;
      objectively locate perforators during surgery and compare the results to the preoperative&#xD;
      imaging assessment of the flap's vascular anatomy.&#xD;
&#xD;
      II. To determine whether the preoperative CT angiogram allows the microsurgeon to correctly&#xD;
      identify the perforators that are ultimately used as the pedicle for the flap.&#xD;
&#xD;
      OUTLINE:&#xD;
&#xD;
      Patients undergo deep inferior epigastric perforator (DIEP) flap breast reconstruction using&#xD;
      the StealthStation navigation system.&#xD;
&#xD;
      After completion of study treatment, patients are followed up at 1-2 weeks and 1 month, then&#xD;
      every 3 months for 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Actual">January 10, 2011</start_date>
  <completion_date type="Anticipated">July 2012</completion_date>
  <primary_completion_date type="Anticipated">July 2012</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images</measure>
    <time_frame>Up to 2 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Whether the preoperative CT angiography allowed the surgeon to accurately predict the perforator vessels that were actually used in the final flap design and transfer</measure>
    <time_frame>Up to 2 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Position of the vessels on the imaging correlate to actual location on the abdominal wall for those perforator vessels that are identified both on preoperative review of the images and located during flap dissection</measure>
    <time_frame>Up to 2 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Ductal Breast Carcinoma in Situ</condition>
  <condition>Lobular Breast Carcinoma in Situ</condition>
  <condition>Recurrent Breast Cancer</condition>
  <condition>Stage IA Breast Cancer</condition>
  <condition>Stage IB Breast Cancer</condition>
  <condition>Stage II Breast Cancer</condition>
  <condition>Stage IIIA Breast Cancer</condition>
  <condition>Stage IIIB Breast Cancer</condition>
  <condition>Stage IIIC Breast Cancer</condition>
  <condition>Stage IV Breast Cancer</condition>
  <arm_group>
    <arm_group_label>Supportive care (image-guided breast reconstruction)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergo DIEP flap breast reconstruction using the StealthStation navigation system.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>breast reconstruction</intervention_name>
    <description>Undergo DIEP flap breast reconstruction using the StealthStation navigation system</description>
    <arm_group_label>Supportive care (image-guided breast reconstruction)</arm_group_label>
    <other_name>Mammaplasty</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>intraoperative imaging</intervention_name>
    <description>Undergo DIEP flap breast reconstruction using the StealthStation navigation system</description>
    <arm_group_label>Supportive care (image-guided breast reconstruction)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with histologically confirmed breast carcinoma or breast carcinoma in situ&#xD;
             desiring unilateral or bilateral deep inferior epigastric perforator (DIEP) flap&#xD;
             breast reconstruction&#xD;
&#xD;
          -  Patients must be candidates for elective surgery, without clinically significant&#xD;
             cardiac or pulmonary disease (New York Heart Association [NYHA] class III/IV), without&#xD;
             infection requiring antibiotics, and without serious illness requiring the use of&#xD;
             steroids&#xD;
&#xD;
          -  Patients must have normal kidney function and no allergy to intravenous (IV) dye&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with previous abdominal donor site flaps will be excluded along with patients&#xD;
             with previous extensive surgery to the anterior abdomen&#xD;
&#xD;
          -  Patients with a weight of over 300 pounds or a body size not supported by the CT&#xD;
             scanner will be excluded&#xD;
&#xD;
          -  Patients who are expected to undergo postoperative radiation therapy will be excluded&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ergun Kocak, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ohio State University</affiliation>
  </overall_official>
  <removed_countries>
    <country>United States</country>
  </removed_countries>
  <link>
    <url>http://cancer.osu.edu</url>
    <description>Jamesline</description>
  </link>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>November 14, 2012</study_first_submitted>
  <study_first_submitted_qc>November 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>April 12, 2017</last_update_submitted>
  <last_update_submitted_qc>April 12, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2017</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>Carcinoma</mesh_term>
    <mesh_term>Breast Neoplasms</mesh_term>
    <mesh_term>Carcinoma in Situ</mesh_term>
    <mesh_term>Carcinoma, Ductal, Breast</mesh_term>
    <mesh_term>Breast Carcinoma In Situ</mesh_term>
    <mesh_term>Carcinoma, Intraductal, Noninfiltrating</mesh_term>
    <mesh_term>Carcinoma, Lobular</mesh_term>
  </condition_browse>
  <!-- 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/NCT01729832
org study id: OSU-10106
secondary id: NCI-2012-00693
nct id: NCT01729832
lead sponsor: 
has dmc: Yes
Many hospitals, including the Ohio State University Medical Center, will take pictures of the
      blood vessels in a patient's abdomen before they decide to perform a breast reconstruction
      using the patient's own tissue. These pictures are called computed tomography (CT) angiograms
      and are like a map of each patient's anatomy. However, no study has been reported that
      determined how accurate these pictures are at showing the surgeon where all of the blood
      vessels were located. This study will try to determine if these pictures are missing any
      blood vessels that are found during surgery and if the pictures show the correct location of
      the vessels
PRIMARY OBJECTIVES:

      I. To analyze the accuracy of preoperative CT angiography in determining the location of
      perforator vessels. Through the use of an intraoperative navigation system, we will
      objectively locate perforators during surgery and compare the results to the preoperative
      imaging assessment of the flap's vascular anatomy.

      II. To determine whether the preoperative CT angiogram allows the microsurgeon to correctly
      identify the perforators that are ultimately used as the pedicle for the flap.

      OUTLINE:

      Patients undergo deep inferior epigastric perforator (DIEP) flap breast reconstruction using
      the StealthStation navigation system.

      After completion of study treatment, patients are followed up at 1-2 weeks and 1 month, then
      every 3 months for 2 years.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images
time frame: Up to 2 years
measure: Whether the preoperative CT angiography allowed the surgeon to accurately predict the perforator vessels that were actually used in the final flap design and transfer
time frame: Up to 2 years
measure: Position of the vessels on the imaging correlate to actual location on the abdominal wall for those perforator vessels that are identified both on preoperative review of the images and located during flap dissection
time frame: Up to 2 years
arm group label: Supportive care (image-guided breast reconstruction)
arm group type: Experimental
description: Patients undergo DIEP flap breast reconstruction using the StealthStation navigation system.
intervention type: Procedure
intervention name: breast reconstruction
description: Undergo DIEP flap breast reconstruction using the StealthStation navigation system
arm group label: Supportive care (image-guided breast reconstruction)
other name: Mammaplasty
intervention type: Procedure
intervention name: intraoperative imaging
description: Undergo DIEP flap breast reconstruction using the StealthStation navigation system
arm group label: Supportive care (image-guided breast reconstruction)
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ergun Kocak, MD
role: Principal Investigator
affiliation: Ohio State University
country: United States
url: http://cancer.osu.edu
description: Jamesline
responsible party type: Sponsor
mesh term: Carcinoma
mesh term: Breast Neoplasms
mesh term: Carcinoma in Situ
mesh term: Carcinoma, Ductal, Breast
mesh term: Breast Carcinoma In Situ
mesh term: Carcinoma, Intraductal, Noninfiltrating
mesh term: Carcinoma, Lobular