NCT06963268RecruitingPhase 3
Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
Source: ClinicalTrials.gov · Last updated 19 Dec 2025
Brief summary (registry, in English)
This clinical trial investigates the sentinel lymph node (SLN) technique as a less invasive alternative to conventional lymphadenectomy in patients with early-stage ovarian cancer. The primary objective is to evaluate the effectiveness, safety, and diagnostic accuracy of the SLN approach in detecting lymphatic metastases. By assessing its negative predictive value, the study aims to determine whether the SLN technique can reliably replace systematic pelvic and paraaortic lymphadenectomy. If successful, this technique could minimize surgical morbidity, shorten hospitalization stays, and lower complication rates, ultimately improving patient outcomes.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 30 Apr 2025
- Start date
- 10 Nov 2025
- Primary completion date
- Jun 2028
- Lead sponsor
- Instituto de Investigacion Sanitaria La Fe
- Diseases
- Ovarian cancer
- NCT number
- NCT06963268
- EU CT number
- 2024-520189-67-00
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 200
- From 10 Nov 2025 to the primary completion date, Jun 2028
- 12 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- Failure to obtain informed consent or revocation of informed consent.
Age
- Under 18 years of age at the time of inclusion.
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (12)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Recruiting |
| Clinica Universidad de Navarra Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario 12 de Octubre Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario Fundación Jiménez Díaz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital Universitario La Paz Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| Hospital General Universitario Gregorio Marañón Coordinator of this site? Confirm its status | Madrid | Spain | Recruiting |
| University Hospital Son Espases Coordinator of this site? Confirm its status | Palma | Spain | Recruiting |
| Hospital Universitario de Navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Clínica Universidad de navarra Coordinator of this site? Confirm its status | Pamplona | Spain | Recruiting |
| Hospital Universitario Quironsalud Madrid Coordinator of this site? Confirm its status | Pozuelo de Alarcón | Spain | Recruiting |
| Hospital Universitario Y Politecnico La Fe Coordinator of this site? Confirm its status | Valencia | Spain | Recruiting |
Related publications
- Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II).Int J Gynecol Cancer · 2026 · PMID 41763980
This page is information, not medical advice. Discuss any trial with your doctor.