Using optical guidance for sentinel node biopsy in vulvar cancer
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer
This study is testing if using a special dye can help doctors find lymph nodes in women with early-stage vulvar cancer, to see if it makes the procedure easier and more accurate.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 115 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Rigshospitalet, Denmark Academic / other |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06029504 on ClinicalTrials.gov |
What this trial studies
This study investigates the feasibility of performing sentinel node biopsy in women with vulvar cancer using indocyanine green (ICG) as a single tracer, without lymphoscintigraphy. It focuses on patients with unifocal tumors smaller than 4 cm, specifically those at clinical stages IB and II. Additionally, the study aims to assess the accuracy of combining PET-CT and ultrasound for identifying suspicious lymph nodes and macro-metastases. The approach seeks to improve staging accuracy and potentially reduce the need for more invasive procedures.
Who should consider this trial
Good fit: Ideal candidates are women with primary vulvar cancer or unifocal recurrence, with tumors smaller than 4 cm and no prior surgeries or radiation in the relevant areas.
Not a fit: Patients with prior irradiation of the vulva or groins, previous sentinel node biopsies, or known allergies to ICG or iodine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to less invasive and more accurate staging methods for vulvar cancer, improving patient outcomes.
How similar studies have performed: While this approach is innovative, similar studies have shown promise in improving sentinel node biopsy techniques, suggesting potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with primary vulva cancer, FIGO stage IB (tumor \< 4 cm) * Patients with unifocal recurrence in the vulva (tumor \< 4 cm) located on the side where the patient is surgically naïve in the groin Exclusion Criteria: * Prior irradiation of the vulva or groins * Prior SNB or inguinal lymphadenectomy in the relevant groin * Known allergy to ICG or iodine (ICG contains 5% sodium iodine)
Where this trial is running
Copenhagen
- Copenhagen University Hospital — Copenhagen, Denmark (Recruiting)
Study contacts
- Study coordinator: Ligita P Frøding
- Email: ligita.paskeviciute.froeding@regionh.dk
- Phone: +4522722972
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.