SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants

Completed

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01315119

Run by

Stanford University

People needed

100

Starts

2011-06-01

Expected to finish

2015-09-23

Last updated by the study team

2021-08-06

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 1.0 Ability to understand and the willingness to sign a written informed consent document.
• 1.1 Signed written informed consent.
• 1.2 Women with local or regional recurrences after previous breast conserving surgery.
• 1.3 Women undergoing delayed post mastectomy reconstruction.
• 1.4 Women undergoing prophylactic mastectomy.
• 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.
• 1.6 Women of 18 years of age or older.
• 1.7 ECOG or Karnofsky Performance Status 0,1,2.
• 1.8 Basic Metabolic Panel within 6 months
• 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.

You may not qualify if…

• 2.1 History of liver or kidney failure will not be eligible.
• 2.2 Allergies to iodine containing products will not be eligible.
• 2.3 Women who are pregnant will not be eligible.

Where it is running

• Stanford University School of Medicine — Stanford, California, United States

Full record on ClinicalTrials.gov

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