Ignite Creation Date:
2025-12-24 @ 6:59 PM
Ignite Modification Date:
2025-12-28 @ 3:02 AM
Study NCT ID:
NCT07040657
Status:
RECRUITING
Last Update Posted:
2025-06-27
First Post:
2025-06-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two-Position and Four-Position Cervical Injection Techniques for Sentinel Lymph Node Mapping in Endometrial Cancer Using Methylene Blue
Sponsor:
Dokuz Eylul University
Organization:
Study Overview
Official Title:
Comparison of Two-Point and Four-Point Cervical Injection Techniques Using Methylene Blue for Sentinel Lymph Node Mapping in Endometrial Cancer
Status:
RECRUITING
Status Verified Date:
2025-06
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:
This clinical trial evaluates lymph node mapping in newly diagnosed endometrial cancer patients undergoing surgery. The standard technique uses a 2-point methylene blue cervical injection. The study aims to determine if increasing injection points improves mapping success.
Detailed Description:
In recent years, Sentinel Lymph Node (SLN) mapping has become a key focus in improving surgical outcomes for endometrial cancer. While methylene blue is a cost-effective option for SLN mapping, its detection rates remain suboptimal. This study aims to evaluate whether increasing the injection points from the standard 2-point to a 4-point methylene blue injection improves SLN mapping success.
This randomized controlled trial will include patients with preoperative stage I endometrial carcinoma. Participants will be randomized into two groups: one group will receive a 2-point methylene blue cervical injection, and the other group will receive a 4-point injection.
The primary endpoint is the difference in SLN detection rates between the two techniques. Findings from this study will provide detailed insights into whether the 4-point injection offers a significant advantage over the standard 2-point method.
This randomized controlled trial will include patients with preoperative stage I endometrial carcinoma. Participants will be randomized into two groups: one group will receive a 2-point methylene blue cervical injection, and the other group will receive a 4-point injection.
The primary endpoint is the difference in SLN detection rates between the two techniques. Findings from this study will provide detailed insights into whether the 4-point injection offers a significant advantage over the standard 2-point method.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
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?: