Using indocyanine green (ICG) dye alone to find sentinel lymph nodes in early vulvar cancer
Indocyanine Green for Detection of Sentinel Lymph Nodes In Comparison to ICG Plus Technetium in the Evaluation of Vulvar Squamous Cell Carcinoma: The IGNITE-V Study
This will test whether near-infrared indocyanine green (ICG) alone can find sentinel lymph nodes as well as ICG plus technetium in adults with early-stage vulvar cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 58 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Hamilton Health Sciences Corporation Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Hamilton, Ontario) |
| Trial ID | NCT06039111 on ClinicalTrials.gov |
What this trial studies
This prospective observational comparison uses near-infrared ICG mapping to identify sentinel lymph nodes in adults with early-stage vulvar squamous cell carcinoma and compares detection results to the dual-technique benchmark involving ICG plus technetium. Eligible patients have unifocal tumors less than 4 cm with negative clinical groin exams and are candidates for sentinel lymph node biopsy. Mapped nodes and detection rates will be recorded to calculate sensitivity and accuracy relative to the dual tracer approach. The work is conducted at Hamilton Health Sciences with data collection tied to routine surgical management.
Who should consider this trial
Good fit: Adult women (18 years or older) with FIGO stage IB (depth >1 mm) or small stage II unifocal vulvar squamous cell carcinoma (tumor <4 cm) who have a negative clinical groin exam and are candidates for sentinel lymph node biopsy.
Not a fit: Patients with multifocal or larger tumors, a positive clinical groin exam, prior pelvic/vulvovaginal/inguinal radiation, or those allergic to technetium or ICG are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, using ICG alone could simplify sentinel node mapping, avoid radioactive tracers, and reduce logistical burden for patients and hospitals.
How similar studies have performed: Prior smaller and retrospective series have shown promising sentinel node detection with ICG alone compared with dual tracers, but prospective confirmation in this specific population is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Adult women (18 years of age) with FIGO Stage IB (\> 1 mm depth of invasion) and small Stage II (4 cm) vulvar squamous cell carcinoma or cutaneous melanoma who are candidates for the Sentinel lymph node technique will be included (Negative clinical groin examination and/or imaging and primary unifocal vulvar tumor size of \< 4 cm). Exclusion Criteria: Women with a prior history of pelvic, vulvovaginal or inguinal radiation, with allergy or hypersensitivity to Technetium or ICG, or Bartholin gland cancer will be excluded.
Where this trial is running
Hamilton, Ontario
- Hamilton Health Sciences — Hamilton, Ontario, Canada (Recruiting)
Study contacts
- Study coordinator: Andra Nica, MD
- Email: nica@hhsc.ca
- Phone: 9053879495
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.