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Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer

Primary Purpose

Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Recurrent Breast Cancer

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
breast reconstruction
intraoperative imaging
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ductal Breast Carcinoma in Situ

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with histologically confirmed breast carcinoma or breast carcinoma in situ desiring unilateral or bilateral deep inferior epigastric perforator (DIEP) flap breast reconstruction
  • Patients must be candidates for elective surgery, without clinically significant cardiac or pulmonary disease (New York Heart Association [NYHA] class III/IV), without infection requiring antibiotics, and without serious illness requiring the use of steroids
  • Patients must have normal kidney function and no allergy to intravenous (IV) dye

Exclusion Criteria:

  • Patients with previous abdominal donor site flaps will be excluded along with patients with previous extensive surgery to the anterior abdomen
  • Patients with a weight of over 300 pounds or a body size not supported by the CT scanner will be excluded
  • Patients who are expected to undergo postoperative radiation therapy will be excluded

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Supportive care (image-guided breast reconstruction)

    Arm Description

    Patients undergo DIEP flap breast reconstruction using the StealthStation navigation system.

    Outcomes

    Primary Outcome Measures

    The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images
    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

    Secondary Outcome Measures

    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

    Full Information

    First Posted
    November 14, 2012
    Last Updated
    April 12, 2017
    Sponsor
    Ohio State University Comprehensive Cancer Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01729832
    Brief Title
    Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer
    Official Title
    Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2017
    Overall Recruitment Status
    Withdrawn
    Study Start Date
    January 10, 2011 (Actual)
    Primary Completion Date
    July 2012 (Anticipated)
    Study Completion Date
    July 2012 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Ohio State University Comprehensive Cancer Center

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Ductal Breast Carcinoma in Situ, Lobular Breast Carcinoma in Situ, Recurrent Breast Cancer, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage II Breast Cancer, Stage IIIA Breast Cancer, Stage IIIB Breast Cancer, Stage IIIC Breast Cancer, Stage IV Breast Cancer

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Supportive care (image-guided breast reconstruction)
    Arm Type
    Experimental
    Arm Description
    Patients undergo DIEP flap breast reconstruction using the StealthStation navigation system.
    Intervention Type
    Procedure
    Intervention Name(s)
    breast reconstruction
    Other Intervention Name(s)
    Mammaplasty
    Intervention Description
    Undergo DIEP flap breast reconstruction using the StealthStation navigation system
    Intervention Type
    Procedure
    Intervention Name(s)
    intraoperative imaging
    Intervention Description
    Undergo DIEP flap breast reconstruction using the StealthStation navigation system
    Primary Outcome Measure Information:
    Title
    The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images
    Time Frame
    Up to 2 years
    Title
    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
    Secondary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Patients with histologically confirmed breast carcinoma or breast carcinoma in situ desiring unilateral or bilateral deep inferior epigastric perforator (DIEP) flap breast reconstruction Patients must be candidates for elective surgery, without clinically significant cardiac or pulmonary disease (New York Heart Association [NYHA] class III/IV), without infection requiring antibiotics, and without serious illness requiring the use of steroids Patients must have normal kidney function and no allergy to intravenous (IV) dye Exclusion Criteria: Patients with previous abdominal donor site flaps will be excluded along with patients with previous extensive surgery to the anterior abdomen Patients with a weight of over 300 pounds or a body size not supported by the CT scanner will be excluded Patients who are expected to undergo postoperative radiation therapy will be excluded
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ergun Kocak, MD
    Organizational Affiliation
    Ohio State University
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Links:
    URL
    http://cancer.osu.edu
    Description
    Jamesline

    Learn more about this trial

    Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer

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