VISION (Vulvar ICG SLN Detection) Study: Near-Infrared Imaging With Indocyanine Green Injection for the Detection of Sentinel Lymph Nodes in Vulvar Cancer

Status: Active_not_recruiting
Location: See all (8) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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-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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥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

Locations
United States
New Jersey
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)
Basking Ridge
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)
Middletown
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale
New York
Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities)
Commack
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York
Memorial Sloan Kettering Nassau (Limited Protocol Activities)
Uniondale
Texas
Houston Methodist Cancer Center (Data Collection Only)
Houston
Time Frame
Start Date: 2023-11-06
Completion Date: 2026-11
Participants
Target number of participants: 22
Treatments
Experimental: patients undergoing preoperative lymphoscintigraphy
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.
Related Therapeutic Areas
Sponsors
Leads: Memorial Sloan Kettering Cancer Center

This content was sourced from clinicaltrials.gov

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