Ignite Creation Date:
2025-12-24 @ 5:26 PM
Ignite Modification Date:
2025-12-27 @ 7:23 AM
Study NCT ID:
NCT06035068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-29
First Post:
2023-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SLN Mapping and ICG Dye for Vulvar Cancer
Sponsor:
Tufts Medical Center
Organization:
Study Overview
Official Title:
Sentinel Lymph Node Mapping and Detection With Indocyanine Green and Spy-Phi Handheld Camera Technology in Early-Stage Vulvar Cancer (PILOT)
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
None
Brief Summary:
Doctors typically use blue dye to assist in locating and extracting lymph nodes for biopsy. However, this process can prove somewhat challenging for both patients and medical teams due to its need for extensive coordination and the assistance of a nuclear medicine team. Some studies have talked about using a different method to find these lymph nodes using a special dye called Indocyanine Green (ICG). This method involves shining a special camera on the skin. So far, no studies have directly compared the ICG method to the standard blue dye. The ICG camera could make things easier for patients and doctors, and more patients might choose to have their lymph nodes checked with this new method. The goal of our study is to see if using the ICG dye is just as good as the standard method of blue dye.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?: