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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 : Completed
First Posted : March 15, 2011
Last Update Posted : August 6, 2021
Sponsor:
Information provided by (Responsible Party):
Stanford University

Tracking Information
First Submitted Date March 11, 2011
First Posted Date March 15, 2011
Last Update Posted Date August 6, 2021
Study Start Date June 2011
Actual Primary Completion Date September 23, 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 28, 2011)
  • 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 ]
Original Primary Outcome Measures
 (submitted: March 11, 2011)
Serum PSA measured after 12 weeks is the study endpoint. If after 10 patients <2 have a response, the study will be halted. [ Time Frame: 12 weeks ]
Change History
Current Secondary Outcome Measures
 (submitted: March 28, 2011)
  • 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 ]
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title SPY Intra-Operative Angiography & Skin Perfusion in Immediate Breast Reconstruction w/ Implants
Official Title The Role of SPY Intra-Operative Angiography in Determining Adequate Skin Perfusion in Immediate Breast Reconstruction With Implants
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.
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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population The patient population includes women with unilateral or bilateral breast cancer undergoing immediate or delayed breast reconstruction.
Condition Breast Cancer
Intervention Procedure: SPY Intra-Operative Angiography
Calculated per patient
Other Name: Novadaq SPY
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 11, 2011)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date September 23, 2015
Actual Primary Completion Date September 23, 2014   (Final data collection date for primary outcome measure)
Eligibility 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.

Sex/Gender
Sexes Eligible for Study: Female
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01315119
Other Study ID Numbers BRS0005
BRS0005 ( Other Identifier: Stanford University )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Stanford University
Study Sponsor Stanford University
Collaborators Not Provided
Investigators
Principal Investigator: Geoffrey C. Gurtner Stanford University
PRS Account Stanford University
Verification Date August 2020