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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: SPY Elite Imaging; Drug: Indocyanine Green; Drug: Isosulfan blue; Drug: 99technetium-sulfur colloid radiolabel

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: ISB and ICG; 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.

Device: SPY Elite Imaging; 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; Drug: Indocyanine Green; started at 1mg /mL If fluorescence is not detected with this dose, then it will be increased by 50%.; Other Names: ICG; IC-GREEN; Drug: Isosulfan blue; 3 to 5 mL If fluorescence is not detected with this dose, then it will be increased by 50%.; Other Names: Lymphazurin; IS-BLUE; ISB; Drug: 99technetium-sulfur colloid radiolabel; Other Names: 99tech

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 day

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Irene Wapnir, Stanford University

Study record dates

Study Major Dates

• Study Start: July 1, 2012
• Primary Completion (Actual): March 17, 2015
• Study Completion (Actual): March 17, 2015

Study Registration Dates

• First Submitted: January 16, 2013
• First Submitted That Met QC Criteria: January 16, 2013
• First Posted (Estimate): January 18, 2013

Study Record Updates

• Last Update Posted (Actual): December 11, 2017
• Last Update Submitted That Met QC Criteria: November 7, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Molecular Mechanisms of Pharmacological Action; Radiopharmaceuticals; Technetium Tc 99m Sulfur Colloid
• Other Study ID Numbers: IRB-21030; SU-06122012-10130 (Other Identifier: Stanford University); BRS0022 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No