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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
Sponsor:
Information provided by (Responsible Party):
Stanford University

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment
Breast Cancer Procedure: SPY Intra-Operative Angiography

Detailed Description:
Breast cancer is the most common malignancy among women, and over 180,000 women will be diagnosed with this disease in 2008. Last year, over 57,000 breast reconstructive procedures were performed, of which prosthetic reconstruction constituted 76%. Immediate reconstruction has been favored over delayed procedures for psychological and technical reasons. However, immediate breast reconstruction is associated with significantly higher complication rates (50-52%) than delayed procedures (32-36%), especially when a prosthetic technique is used. For prosthetic reconstructions, the most significant early complications include necrosis of the mastectomy skin flaps, infection, delayed wound healing and exposure of the implant. The published incidence of these complications ranges between 10% and 40% and is predominantly associated with malperfusion of mastectomy skin flaps. Thus, evaluation of skin perfusion and elimination of poorly vascularized areas could help reduce the high rate of complications in immediate breast reconstruction.

Study Design
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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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts
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Intervention Details:
    Procedure: SPY Intra-Operative Angiography
    Calculated per patient
    Other Name: Novadaq SPY

Outcome Measures
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Primary Outcome Measures :
  1. To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: During surgery ]
  2. To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: Immediately post operative ]
  3. To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 2 weeks ]
  4. To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 1 month ]
  5. To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 3 months ]
  6. To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 6 months ]
  7. To compare clinical visual assessment of skin viability with intraoperative SPY imaging. [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. Establish the percentage of patients with ischemia or necrosis in the first year post surgery. [ Time Frame: 12 months ]
  2. Number and type of complications in the first year. [ Time Frame: 12 months ]

Eligibility Criteria
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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
Study Population
The patient population includes women with unilateral or bilateral breast cancer undergoing immediate or delayed breast reconstruction.
Criteria

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.

Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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


Locations
United States, California
Stanford University School of Medicine
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Geoffrey C. Gurtner Stanford University
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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