Ignite Creation Date:
2025-12-24 @ 4:25 PM
Ignite Modification Date:
2025-12-27 @ 3:05 AM
Study NCT ID:
NCT01771666
Status:
COMPLETED
Last Update Posted:
2017-12-11
First Post:
2013-01-16
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Pilot Indocyanine Green Imaging for Mapping of Arm Draining Lymphatics & Nodes in Breast Cancer
Sponsor:
Stanford University
Organization:
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2017-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: