Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06656949
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-08
Brief Title:
Sentinel Lymph Node Mapping With Different Injection Sites of ICG in Endometrium Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Prospective Randomized Trial Comparing the Different Injection Sites of Indocyanine Green ICG in Sentinel Lymph Node Mapping in Patients With Endometrial Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SLN-EC-01
Brief Summary:
The primary goal of this prospective study is to define the efficacy of the sentinel lymph node biopsy SLNB procedure by comparing different method performed in patients with endometrial cancer The aim of this study is to investigate whether the detection rate of sentinel lymph node SLN with two different injection sites may be increased compared to the standard use with single site cervix injection in endometrial cancer
Detailed Description:
The primary treatment for endometrial cancer involves total hysterectomy and bilateral salpingo-oophorectomy with adjuvant radiotherapy andor chemotherapy reserved for patients with advanced disease or who have risk factors for relapse The tumor is confined to the uterus in 85 of endometrial cancers Hence its controversial to perform systematic lymphadenectomy to all patients The primary purpose of the present study is the to investigate the feasibility of sentinel lymph node determination in endometrial cancer patients operated via conventional laparoscopy To determine sentinel lymph nodes cervical indocyanine green will be injected prior to the surgery During the surgery using fluorescent imaging systems sentinel lymph nodes will be removed and examined by frozen section Afterwards systematic pelvic lymphadenectomy will be performed if sentinel lymph node is positive
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None