Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer

• Status: Completed
• Trial end date: 2015-03-17
• Target enrollment: 0
• Participant gender: Female

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stanford University
• Treatments: Technetium Tc 99m Sulfur Colloid

Criteria

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.