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Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.


N/A
18 Years
N/A
Not Enrolling
Female
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

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Trial Information

Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.


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.


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
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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

Up to 2 years

Safety Issue:

No

Principal Investigator

Ergun Kocak, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ohio State University

Authority:

United States: Institutional Review Board

Study ID:

OSU-10106

NCT ID:

NCT01729832

Start Date:

January 2011

Completion Date:

Related Keywords:

  • 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
  • Breast Neoplasms
  • Carcinoma
  • Carcinoma in Situ
  • Carcinoma, Intraductal, Noninfiltrating
  • Carcinoma, Ductal, Breast
  • Carcinoma, Lobular

Name

Location
Ohio State University Medical Center Columbus, Ohio  43210