Phase 2 N=23 Diagnostic

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01771666 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2017

Primary outcome: Primary: Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN) — 8 Participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: SPY Elite Imaging (Device); Indocyanine Green (Drug); Isosulfan blue (Drug); 99technetium-sulfur colloid radiolabel (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Stanford University
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)	8	—
SECONDARY Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes	20; 3; 12; 6; 2	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01771666). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.