Validating sentinel lymph node mapping for early-stage ovarian cancer
Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
We are testing whether the sentinel lymph node technique can accurately find lymph node spread in people with early-stage ovarian cancer so they might avoid full pelvic and paraaortic lymphadenectomy.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Instituto de Investigacion Sanitaria La Fe Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT06963268 on ClinicalTrials.gov |
What this trial studies
This Phase 3 interventional study applies a sentinel lymph node (SLN) mapping technique during staging surgery for apparent FIGO I-II epithelial ovarian cancer. Patients receive SLN identification using standard tracers, with findings compared to systematic pelvic and paraaortic lymphadenectomy to determine diagnostic accuracy and negative predictive value. The study will track safety, complication rates, and hospitalization length to see if the SLN approach lowers surgical morbidity. Results aim to show whether SLN mapping can reliably replace full lymphadenectomy in selected early-stage patients.
Who should consider this trial
Good fit: Women aged 18 years or older with confirmed or suspected epithelial ovarian cancer appearing to be FIGO stage I–II who are planned for staging surgery are ideal candidates.
Not a fit: Patients with prior pelvic or paraaortic lymphatic or relevant vascular surgery, prior lymphoma or abdomino-pelvic tumors, allergy to Tc99 or ICG, or who are pregnant or breastfeeding are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the technique could allow many patients to avoid full pelvic and paraaortic lymphadenectomy, reducing surgical complications, shortening hospital stays, and speeding recovery.
How similar studies have performed: Sentinel node mapping is established in other gynecologic cancers but its use in early ovarian cancer is still relatively novel, with promising smaller studies but not yet definitive Phase 3 confirmation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent prior to the performance of any procedure related to the clinical trial. * Female, 18 years of age or older at the time of inclusion. * Patients with a histopathological diagnosis of malignant ovarian tumor in a deferred study (any epithelial histology), in apparent early stage FIGO I-II, proposed for staging surgery, or patients with suspected malignant ovarian tumor in apparent early stage FIGO I-II, who will undergo exploratory laparotomy and operative biopsy, and if positive, will undergo staging surgery. Exclusion Criteria: * Failure to obtain informed consent or revocation of informed consent. * Under 18 years of age at the time of inclusion. * Previous history of vascular surgery on the aorta, vena cava, or pelvic vessels. * Previous pelvic or paraaortic lymphatic surgery. * Previous lymphoma. * Previous abdomino-pelvic tumor. * Previous allergy to Tc99 or ICG. * Pregnancy/Breastfeeding. Patients who have signed informed consent but do not meet all inclusion criteria and none of the exclusion criteria will be considered as selection failures.
Where this trial is running
Valencia, Valencia
- Hospital Universitario y Politécnico La Fe — Valencia, Valencia, Spain (Recruiting)
Study contacts
- Study coordinator: Mónica Cebrián Coordinator Clinical Research Area
- Email: investigacion_clinica@iislafe.es
- Phone: +34961246731
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.