SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants
Trial ID or NCT#
Status
Purpose
The investigators hope to learn the value of the SPY ELITE® intra-operative angiography in reducing post-operative complications associated with low breast skin blood flow after breast reconstruction using implants.
Official Title
The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants
Eligibility Criteria
- 3.1.0 Ability to understand and the willingness to sign a written informed consent document.
- 3.1.1 Signed written informed consent.
- 3.1.2 Women with local or regional recurrences after previous breast conserving surgery.
- 3.1.3 Women undergoing delayed post mastectomy reconstruction.
- 3.1.4 Women undergoing prophylactic mastectomy.
- 3.1.5 Women with invasive or non-invasive breast cancer, receiving breast conserving surgery with or without reduction mammoplasty or mastectomy, with or without immediate reconstruction.
- 3.1.6 Women of 18 years of age or older.
- 3.1.7 ECOG or Karnofsky Performance Status 0,1,2.
- 3.1.8 Basic Metabolic Panel within 6 months
- 3.1.9 Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements.
- 3.2.1 History of liver or kidney failure will not be eligible.
- 3.2.2 Allergies to iodine containing products will not be eligible.
- 3.2.3 Women who are pregnant will not be eligible.
Investigator(s)
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Contact
ccto-office@stanford.edu
650-498-7061
View on ClinicalTrials.gov