Using optical guidance for sentinel node biopsy in vulvar cancer
Optical Guided Sentinel Node Biopsy for Staging of Vulvar Cancer ( SENTIVUC II)
Rigshospitalet, Denmark · NCT06161428
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 |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Rigshospitalet, Denmark (other) |
| Locations | 1 site (Copenhagen) |
| Trial ID | NCT06161428 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are women with vulvar cancer characterized by tumors larger than 4 cm, multifocal tumors, or local recurrences.
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.
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 performed: While this approach is innovative, similar studies using advanced imaging techniques for lymph node assessment have shown promise in other cancer types.
Eligibility criteria
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 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.
Conditions: Vulva Cancer, Sentinel Lymph Node