SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants
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ClinicalTrials.gov Identifier: NCT01315119 |
Recruitment Status
:
Active, not recruiting
First Posted
: March 15, 2011
Last Update Posted
: February 6, 2017
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Condition or disease | Intervention/treatment |
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Breast Cancer | Procedure: SPY Intra-Operative Angiography |
Study Type : | Observational |
Estimated Enrollment : | 100 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants |
Study Start Date : | June 2011 |
Actual Primary Completion Date : | September 23, 2014 |
Estimated Study Completion Date : | April 30, 2017 |

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Procedure: SPY Intra-Operative Angiography
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: During surgery ]
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: Immediately post operative ]
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 2 weeks ]
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 1 month ]
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 3 months ]
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 6 months ]
- To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 12 months ]
- Establish the percentage of patients with ischemia or necrosis in the first year post surgery. [ Time Frame: 12 months ]
- Number and type of complications in the first year. [ Time Frame: 12 months ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion 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.
Exclusion Criteria:
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01315119
United States, California | |
Stanford University School of Medicine | |
Stanford, California, United States, 94305 |
Principal Investigator: | Geoffrey C. Gurtner | Stanford University |
Responsible Party: | Stanford University |
ClinicalTrials.gov Identifier: | NCT01315119 History of Changes |
Other Study ID Numbers: |
BRS0005 BRS0005 ( Other Identifier: Stanford University ) |
First Posted: | March 15, 2011 Key Record Dates |
Last Update Posted: | February 6, 2017 |
Last Verified: | February 2017 |