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NCT06127836 Clinical Trial

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

Vulvar Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06127836
Other study ID # 23-310
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 6, 2023
Est. completion date November 2026

Study information
Verified date March 2024
Source Memorial Sloan Kettering Cancer Center
Contact Vance Broach, MD
Phone 212-639-6876
Email broachv@mskcc.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date November 2026
Est. primary completion date November 2026
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• ICG guided sentinel lymph node biopsy
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. Once the surgeon has identified the SLN in this way, he or she will be unblinded to the results of the lymphoscintigraphy and will use the results of preoperative imaging and an intraoperative gamma counter to confirm the SLNs.

Locations
Country Name City State
United States Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) Basking Ridge New Jersey
United States Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) Commack New York
United States Memorial Sloan Kettering Westchester (Limited Protocol Activities) Harrison New York
United States Houston Methodist Cancer Center (Data Collection Only) Houston Texas
United States Memorial Sloan Kettering Monmouth (Limited Protocol Activities) Middletown New Jersey
United States Memorial Sloan Kettering Bergen (Limited Protocol Activities) Montvale New Jersey
United States Memorial Sloan Kettering Cancer Center (All Protocol Activities) New York New York
United States Memorial Sloan Kettering Nassau (Limited Protocol Activities) Uniondale New York

Sponsors (1)
Lead Sponsor Collaborator
Memorial Sloan Kettering Cancer Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary success of identifying the SLN by use of near-infrared imaging with ICG injection. Patients will be eligible for assessment if they undergo attempted SLN mapping by lymphoscintigraphy and near-infrared imaging with ICG injection. The primary endpoint is the accurate identification of the SLN, defined as the uptake of ICG in the proximalmost draining lymph node in the inguinofemoral chain. Evaluate the ability of near-infrared imaging with ICG injection to detect the inguinofemoral SLN in patients with early-stage vulvar cancer, compared with radiocolloid lymphoscintigraphy, the current standard. 18 months
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