Trials / Withdrawn
WithdrawnNCT01729832
Stereotactic Image-Guided Navigation During Breast Reconstruction in Patients With Breast Cancer
Intraoperative Stereotactic Image-guided Navigation of Perforators for DIEP Flap Breast Reconstruction.
- Status
- Withdrawn
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Ohio State University Comprehensive Cancer Center · Academic / Other
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | breast reconstruction | Undergo DIEP flap breast reconstruction using the StealthStation navigation system |
| PROCEDURE | intraoperative imaging | Undergo DIEP flap breast reconstruction using the StealthStation navigation system |
Timeline
- Start date
- 2011-01-10
- Primary completion
- 2012-07-01
- Completion
- 2012-07-01
- First posted
- 2012-11-20
- Last updated
- 2017-04-13
Source: ClinicalTrials.gov record NCT01729832. Inclusion in this directory is not an endorsement.