Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer
Trial ID or NCT#
NCT01771666
Status
NOT RECRUITING
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
Eligibility Criteria
Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: Female
Accepts Healthy Volunteers: No
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.
Investigator(s)
Irene Wapnir, MD
Surgical oncologist,
Breast surgeon,
Breast specialist
Professor of Surgery (General Surgery)
Contact us to find out if this trial is right for you.
Contact
Shannon Meyer
650-724-1953
View on ClinicalTrials.gov
