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

Stanford University

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Indocyanine Green; Device: SPY Elite Imaging; Drug: 99technetium-sulfur colloid radiolabel; Drug: Isosulfan blue

Study type: Interventional

Funder types: Other

Identifiers

NCT01771666

SU-06122012-10130 (Other Identifier)

IRB-21030

BRS0022 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 23 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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23 participants in 1 patient group

ISB and ICG

Experimental group

Description:

The dose of Isosulfan blue (ISB) dye and Indocyanine green (ICG) solution will be started. (IC-GREEN) SPY Elite Imaging willbe used to capture the images of axillary cavity.

Treatment:

Device: SPY Elite Imaging

Drug: Isosulfan blue

Drug: 99technetium-sulfur colloid radiolabel

Drug: Indocyanine Green