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Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer
Not Recruiting
Trial ID: NCT01771666
Purpose
The purpose of this study is to determine if Indocyanine Green (IC-GREEN) is comparable to
isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes
during nodal staging procedures in breast cancer.
Official Title
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
Stanford Investigator(s)
Irene Wapnir, MD
Professor of Surgery (General Surgery)
Eligibility
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.
Intervention(s):
device: SPY Elite Imaging
drug: Indocyanine Green
drug: Isosulfan blue
drug: 99technetium-sulfur colloid radiolabel
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Shannon Meyer
650-724-1953