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Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer
Trial ID: NCT01771666
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.
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
- 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
- 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
- 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.
device: SPY Elite Imaging
drug: Indocyanine Green
drug: Isosulfan blue
drug: 99technetium-sulfur colloid radiolabel
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