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

The Ohio State University

Status: Withdrawn

Conditions: Stage IIIA Breast Cancer; Stage IB Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage II Breast Cancer; Stage IA Breast Cancer; Lobular Breast Carcinoma in Situ; Ductal Breast Carcinoma in Situ; Recurrent Breast Cancer; Stage IV Breast Cancer

Treatments: Procedure: intraoperative imaging; Procedure: breast reconstruction

Study type: Interventional

Funder types: Other

Identifiers

NCT01729832

OSU-10106

NCI-2012-00693 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

Supportive care (image-guided breast reconstruction)

Experimental group

Description:

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

Treatment:

Procedure: breast reconstruction

Procedure: intraoperative imaging