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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01729832
Other study ID # OSU-10106
Secondary ID NCI-2012-00693
Status Withdrawn
Phase N/A
First received November 14, 2012
Last updated April 12, 2017
Start date January 10, 2011
Est. completion date July 2012

Study information

Verified date April 2017
Source Ohio State University Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2012
Est. primary completion date July 2012
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Procedure:
breast reconstruction
Undergo DIEP flap breast reconstruction using the StealthStation navigation system
intraoperative imaging
Undergo DIEP flap breast reconstruction using the StealthStation navigation system

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University Comprehensive Cancer Center

Outcome

Type Measure Description Time frame Safety issue
Primary The number of perforators that are found intraoperatively but not seen preoperatively on CT angiogram images Up to 2 years
Primary 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 Up to 2 years
Secondary 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 Up to 2 years
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