Clinical trial NCT01729832: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: 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
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-11-20
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images
timeFrame: 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
timeFrame: Up to 2 years
Secondary outcomes:
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
timeFrame: Up to 2 years
Other outcomes:
Locations:
Study officials:
affiliation: Ohio State University
name: Ergun Kocak, MD
role: PRINCIPAL_INVESTIGATOR
References: