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

Breast Cancer Clinical Trial

Official title:

The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01315119
• Other study ID #: BRS0005
• Secondary ID: BRS0005
• Status: Completed
• Start date: June 2011
• Est. completion date: September 23, 2015

Study information

• Verified date: August 2020
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 23, 2015
• Est. primary completion date: September 23, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Procedure:
• SPY Intra-Operative Angiography
Calculated per patient

Locations

Country	Name	City	State
United States	Stanford University School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To compare clinical visual assessment of skin viability with intraoperative SPY imaging.		During surgery
Primary	To compare clinical visual assessment of skin viability with intraoperative SPY imaging.		Immediately post operative
Primary	To compare clinical visual assessment of skin viability with intraoperative SPY imaging.		2 weeks
Primary	To compare clinical visual assessment of skin viability with intraoperative SPY imaging.		1 month
Primary	To compare clinical visual assessment of skin viability with intraoperative SPY imaging.		3 months
Primary	To compare clinical visual assessment of skin viability with intraoperative SPY imaging.		6 months
Primary	To compare clinical visual assessment of skin viability with intraoperative SPY imaging.		12 months
Secondary	Establish the percentage of patients with ischemia or necrosis in the first year post surgery.		12 months
Secondary	Number and type of complications in the first year.		12 months