Study of Near-Infrared Imaging With Indocyanine Green for Detection of Sentinel Lymph Nodes in People With Vulvar Cancer

Memorial Sloan Kettering Cancer Center (MSK)

Status: Active, not recruiting

Conditions: Vulvar Cancer

Treatments: Procedure: ICG guided sentinel lymph node biopsy

Study type: Interventional

Funder types: Other

Identifiers

NCT06127836

23-310

Details and patient eligibility

About

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-infrared (ICG-NIR) imaging with lymphoscintigraphy. All participants in this study will be scheduled for standard surgical treatment at Memorial Sloan Kettering Cancer Center (MSK). This surgical treatment includes SLN mapping (with both lymphoscintigraphy and ICG-NIR imaging) and SLN biopsy.

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• ≥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 criteria

• 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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

22 participants in 1 patient group

patients undergoing preoperative lymphoscintigraphy

Experimental group

Description:

Patients will undergo radiocolloid lymphoscintigraphy before their surgery; the surgeon will be blinded to the results of this procedure. The surgeon will subsequently inject ICG in accordance with the SLN protocol in the operating room and will identify and remove the SLN by use of near-infrared imaging guidance only.

Treatment:

Procedure: ICG guided sentinel lymph node biopsy