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A Pilot Study to Assess the Utility of Indocyanine Green™ (IC-GREEN™) SPY Imaging in the Mapping of Arm Draining Lymphatics and Nodes During Sentinel Node Resection With or Without Axillary Dissection in Breast Cancer


N/A
18 Years
90 Years
Open (Enrolling)
Female
Breast Cancer

Thank you

Trial Information

A Pilot Study to Assess the Utility of Indocyanine Green™ (IC-GREEN™) SPY Imaging in the Mapping of Arm Draining Lymphatics and Nodes During Sentinel Node Resection With or Without Axillary Dissection in Breast Cancer


Inclusion Criteria:



- Ability to understand and the willingness to sign a written informed consent
document.

- Signed written informed consent.

- Women undergoing sentinel lymph node biopsy.

- Women with breast cancer with known or suspected lymph node involvement.

- Women undergoing sentinel node identification and completion axillary lymph node
dissection.

- Women of 18 years of age or older.

- Eastern Cooperative Oncology Group (ECOG) or Karnofsky Performance Status 0,1,2.

- Complete Blood Count (CBC) and basic Metabolic Panel within 6 months

Exclusion Criteria:

- 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.

- Psychiatric or addictive disorders or other conditions that, in the opinion of the
investigator, would preclude the patient from meeting the study requirements.

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

Percent of patients with blue and fluorescent lymphatics and nodes

Outcome Time Frame:

1 month

Safety Issue:

No

Principal Investigator

Irene Wapnir

Investigator Role:

Principal Investigator

Investigator Affiliation:

Stanford University

Authority:

United States: Institutional Review Board

Study ID:

BRS0022

NCT ID:

NCT01771666

Start Date:

July 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

Name

Location

Stanford University Cancer Institute Stanford, California  94305