Status:
NOT_YET_RECRUITING
SLN Mapping and ICG Dye for Vulvar Cancer
Lead Sponsor:
Tufts Medical Center
Conditions:
Vulva Cancer
Eligibility:
FEMALE
18+ years
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...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Patients with early-stage SCC (diameter \<4 cm) of the vulva without suspicious lymph nodes at palpation or imaging who are planned for surgery at Tufts Medical Center.
- Patients with squamous cell carcinoma, depth of invasion \> 1mm
- Patients with T1 or T2 tumors (FIGO staging) \< 4 cm, not encroaching in urethra or anus with clinically negative inguinofemoral lymph nodes
- Localization and size of the tumor are such that perilesional injection of the tracers at three or four sites is possible
- Preoperative imaging do not show enlarged (\<1.5 cm)/ suspicious nodes
- Willing and able to give informed consent
Exclusion
- Inoperable tumors and tumors with diameter \> 4 cm
- Patients with inguinofemoral lymph nodes that are palpable on clinical exam suspicious for metastases or with cytologically proven inguinofemoral lymph node metastases
- Radiologically enlarged (\>1.5 cm) inguinofemoral lymph nodes
- Patients with multifocal tumors
- Pregnancy
Key Trial Info
Start Date :
November 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT06035068
Start Date
November 1 2025
End Date
January 1 2026
Last Update
September 29 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Tufts Medical Center
Boston, Massachusetts, United States, 02111