Status:
ACTIVE_NOT_RECRUITING
Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
Vulvar Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to compare two types of imaging for sentinel lymph node (SLN) mapping in people with early-stage vulvar cancer. The researchers will compare indocyanine green near-infrare...
Eligibility Criteria
Inclusion
- ≥18 years of age
- Newly diagnosed with vulvar cancer and scheduled to undergo SLN biopsy (patients with squamous cell carcinomas and melanomas will be included)
- Primary tumor ≤4 cm in size
- For patients with squamous cell carcinoma, \>1 mm of invasion is required
Exclusion
- Clinically or radiographically enlarged inguinofemoral lymph nodes (if imaging is performed)
- Presence of distant metastases
- Absolute contraindication to radiocolloid Tc-99 or ICG
- Nonsquamous or nonmelanoma histologic subtype
Key Trial Info
Start Date :
November 6 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2026
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT06127836
Start Date
November 6 2023
End Date
November 1 2026
Last Update
November 5 2025
Active Locations (8)
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1
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
2
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown, New Jersey, United States, 07748
3
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, United States, 07645
4
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack, New York, United States, 11725