Using near-infrared imaging to detect lymph nodes in vulvar cancer patients
VISION (Vulvar ICG SLN Detection) Study: Near-Infrared Imaging With Indocyanine Green Injection for the Detection of Sentinel Lymph Nodes in Vulvar Cancer
This study is testing a new imaging method to see if it can better identify important lymph nodes in women with early-stage vulvar cancer compared to the usual technique.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Memorial Sloan Kettering Cancer Center Academic / other |
| Locations | 8 sites (Basking Ridge, New Jersey and 7 other locations) |
| Trial ID | NCT06127836 on ClinicalTrials.gov |
What this trial studies
This study aims to compare two imaging techniques for sentinel lymph node mapping in patients with early-stage vulvar cancer. Participants will undergo standard surgical treatment at Memorial Sloan Kettering Cancer Center, which includes both lymphoscintigraphy and near-infrared imaging with indocyanine green (ICG). The goal is to determine the effectiveness of ICG-NIR imaging compared to traditional methods in identifying sentinel lymph nodes. This could enhance surgical outcomes and improve cancer staging.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older, newly diagnosed with vulvar cancer, and scheduled for sentinel lymph node biopsy.
Not a fit: Patients with enlarged lymph nodes or distant metastases, or those with contraindications to the imaging agents, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate detection of sentinel lymph nodes, potentially improving surgical outcomes for vulvar cancer patients.
How similar studies have performed: Similar studies using near-infrared imaging for lymph node detection have shown promising results, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Basking Ridge, New Jersey and 7 other locations
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) — Basking Ridge, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) — Middletown, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) — Montvale, New Jersey, United States (Recruiting)
- Memorial Sloan Kettering Suffolk - Commack (Limited Protocol Activities) — Commack, New York, United States (Recruiting)
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) — Harrison, New York, United States (Recruiting)
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York, New York, United States (Recruiting)
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) — Uniondale, New York, United States (Recruiting)
- Houston Methodist Cancer Center (Data Collection Only) — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Vance Broach, MD — Memorial Sloan Kettering Cancer Center
- Study coordinator: Vance Broach, MD
- Email: broachv@mskcc.org
- Phone: 212-639-6876
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.