Ignite Creation Date:
2024-05-06 @ 8:24 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06378944
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-01
Brief Title:
Selective Sentinella Lymph Node Biopsy with Indocyanine Green in Patients with Breast Cancer
Sponsor:
Omphis Foundation
Organization:
Omphis Foundation
Study Overview
Official Title:
INDOCYANINE GREEN for SELECTIVE SENTINELLA AXILLARY LYMPH NODE BIOPSY in PATIENTS with BREAST CANCER
Status:
RECRUITING
Status Verified Date:
2024-09
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:
INSEAN
Brief Summary:
The current observational study aims to perform the sentinel lymph node in breast cancer in the usual way with technetium 99 and add a second tracer indocyanine green The objective is to evaluate the detection rate of the lymph node with indocyanine green compared to the usual technique
Detailed Description:
In the operating room 1 ml of indocyaninge grenn will be injectec periareolar After 5 minutes the lymph node will be detected and extracted The comparison between the lymph nodes detected with Technetium 99 and indocyanine green will be analysed
Study Oversight
Has Oversight DMC:
None
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?:
None
Is an FDA AA801 Violation?:
None