Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer
| Status: | Completed |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - 90 |
| Updated: | 12/13/2017 |
| Start Date: | July 2012 |
| End Date: | March 17, 2015 |
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
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.
isosulfan blue (IS-BLUE) in the identification of arm lymphatics and arm-draining nodes
during nodal staging procedures in breast cancer.
It is the objective of the current study to test Indocyanine Green (IC-GREEN) as an agent for
mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the
setting of sentinel node procedures with or without axillary node dissections in women with
breast cancer. All participants will also have tumor samples evaluated with
99technetium-sulfur colloid, a radiolabel used to identify tumor markers.
mapping arm draining lymphatics and nodes and compare it to isosulfan blue (IS-BLUE) in the
setting of sentinel node procedures with or without axillary node dissections in women with
breast cancer. All participants will also have tumor samples evaluated with
99technetium-sulfur colloid, a radiolabel used to identify tumor markers.
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.
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