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

Stanford University23 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

SPY Elite ImagingDEVICE

A camera that is directed into the axillary cavity to try to capture an image of the tumor site labeled with Indocyanine green before and after excising sentinel nodes

Indocyanine GreenDRUG

started at 1mg /mL If fluorescence is not detected with this dose, then it will be increased by 50%.

Isosulfan blueDRUG

3 to 5 mL If fluorescence is not detected with this dose, then it will be increased by 50%.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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.

Locations (1)

Stanford University, School of Medicine

Stanford, California, United States

Outcomes

Primary Outcomes

Agreement of Labeling Between Isosulfan Blue (IS-BLUE) and Indocyanine Green (IC-GREEN)

Number of women with agreement of the two dies \[ie, isosulfan blue (IS-BLUE) and indocyanine green (IC-GREEN)\] on all nodes examined in the lymphatics and arm-draining lymph nodes, during nodal staging procedures for surgery to treat breast cancer with curative intent.

Time frame: 1 day

Secondary Outcomes

Detection of Indocyanine Green (IC-GREEN); Isosulfan Blue (IS-BLUE); and 99technetium-sulfur Colloid Radiolabel in Resected Sentinel Nodes

The outcome is expressed as the number of participants whose resected sentinel lymph nodes (SLN) bound 99technetium-sulfur colloid (99tech), a tumor marker radiolabel; Indocyanine Green (IC-GREEN; "GREEN"), a fluorescent label; or isosulfan blue (IS-BLUE; "BLUE"), a visual dye. Results are expressed as: * "Any HOT" = Those whose samples bound 99tech. * "Not HOT" = Those whose samples did not bind 99tech. * "Not HOT (also no BLUE, no GREEN)" = Those whose samples did not bind 99tech; and also did not bind IC-GREEN nor IS-BLUE. * "HOT, BLUE, GREEN" = Those whose samples bound all of 99tech; IC-GREEN; and IS-BLUE. * "HOT, no BLUE, no GREEN" = Those whose samples bound 99tech, but did not bind either of IC-GREEN nor IS-BLUE. * "HOT, GREEN only, no BLUE" = Those whose samples bound 99tech and IC-GREEN, but did not bind IS-BLUE.

Time frame: 1 day

Data from ClinicalTrials.gov

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