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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01771666
• Other study ID #: IRB-21030
• Secondary ID: SU-06122012-1013
• Status: Completed
• Phase: Phase 2
• First received: January 16, 2013
• Last updated: November 7, 2017
• Start date: July 2012
• Est. completion date: March 17, 2015

Study information

• Verified date: November 2017
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: March 17, 2015
• Est. primary completion date: March 17, 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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%.
• Isosulfan blue
3 to 5 mL If fluorescence is not detected with this dose, then it will be increased by 50%.
• 99technetium-sulfur colloid radiolabel

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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