Pilot Indocyanine Green™ Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer
Conditions
Breast Cancer
Conditions: official terms
Breast Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Observational Model: Cohort, Time Perspective: Prospective
Intervention
Name: (IC-GREEN™) SPY Elite® Imaging
Type: Device
Overall Status
Recruiting
Summary
To determine concordance between isosulfan blue (ISB) and indocyanine green (IC-GREEN™) in the identification of lymphatics and arm-draining nodes during nodal staging procedures in breast cancer.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 90 Years
Minimum Age: 18 Years
Gender: Female
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.
Location
Stanford University Cancer Institute
Stanford, California, United States
Status: Recruiting
Contact: Shannon Meyer - 650-724-1953 - smeyer27@stanford.edu
Start Date
July 2012
Sponsors
Stanford University
Source
Stanford University
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page