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

NCT01315119 | Completed DMC

• 1 other identifier: BRS0005
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (7)

• To compare clinical visual assessment of skin viability with intraoperative SPY imaging.

  During surgery

• To compare clinical visual assessment of skin viability with intraoperative SPY imaging.

  Immediately post operative

• To compare clinical visual assessment of skin viability with intraoperative SPY imaging.

  2 weeks

• To compare clinical visual assessment of skin viability with intraoperative SPY imaging.

  1 month

• To compare clinical visual assessment of skin viability with intraoperative SPY imaging.

  3 months

• To compare clinical visual assessment of skin viability with intraoperative SPY imaging.

  6 months

• To compare clinical visual assessment of skin viability with intraoperative SPY imaging.

  12 months

Secondary Outcomes (2)

• Establish the percentage of patients with ischemia or necrosis in the first year post surgery.

  12 months

• Number and type of complications in the first year.

  12 months

Interventions

SPY Intra-Operative Angiography PROCEDURE

Calculated per patient

Also known as: Novadaq SPY

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent document.
• Signed written informed consent.
• Women with local or regional recurrences after previous breast conserving surgery.
• Women undergoing delayed post mastectomy reconstruction.
• Women undergoing prophylactic mastectomy.
• Women with invasive or non-invasive breast cancer, receiving breast conserving surgery with or without reduction mammoplasty or mastectomy, with or without immediate reconstruction.
• Women of 18 years of age or older.
• ECOG or Karnofsky Performance Status 0,1,2.
• Basic Metabolic Panel within 6 months
• 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:

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

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Geoffrey C. Gurtner

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 11, 2011
• First Posted: March 15, 2011
• Study Start: June 1, 2011
• Primary Completion: September 23, 2014
• Study Completion: September 23, 2015
• Last Updated: August 6, 2021

Record last verified: 2020-08

Locations

US (1)