Using optical guidance for sentinel node biopsy in vulvar cancer
Official title: Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer ( SENTIVUC II)
Run by Copenhagen University Hospital, Rigshospitalet · NCT06161428 · Data updated 2026-11-12
This study is testing if using special imaging techniques can help doctors better identify lymph nodes in women with vulvar cancer to improve their treatment options.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | Women only |
| Enrollment | 100 (estimated) |
| Sponsor | Copenhagen University Hospital, Rigshospitalet Academic / other |
| Locations | 1 site (Copenhagen) |
| Status | Recruiting |
| Started | May 1, 2023 |
| Main results expected | July 1, 2026 |
| Study ends | July 1, 2027 |
| Registry record updated | December 13, 2023 |
| Trial ID | NCT06161428 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women with vulvar cancer characterized by tumors larger than 4 cm, multifocal tumors, or local recurrences.
✕Probably not a fit
Patients who have undergone previous external irradiation of the vulva or groins, or those with known allergies to ICG or iodine, may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the feasibility of combining sentinel lymph node mapping with FDG-PET/CT imaging in women diagnosed with vulvar cancer, specifically those with tumors larger than 4 cm, multifocal tumors, or local recurrences. The observational approach aims to assess how effectively this technique can stage the cancer and potentially improve treatment outcomes. By utilizing advanced imaging techniques, the study seeks to enhance the accuracy of lymph node assessment in this patient population.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate staging of vulvar cancer, improving treatment decisions and outcomes for patients.
How similar studies have gone: While this approach is innovative, similar studies using advanced imaging techniques for lymph node assessment have shown promise in other cancer types.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with vulva cancer, tumor \> 4 cm, multifocal tumor, or local recurrences in vulva Exclusion Criteria: * Previous external irradiation of the vulva or groins * Former sentinel node or inguinal lymphadenectomy in the relevant groin * Known allergy to ICG or iodine * Patient is in active treatment for other cancer and/or disseminated disease
Where it's running
-
Copenhagen University Hospital
Copenhagen, Denmark Recruiting
Study contacts
- Study coordinator: Ligita P Frøding
- Email: ligita.paskeviciute.froeding@regionh.dk
- Phone: +4522722972
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.