NCT06963268 Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
| NCT ID | NCT06963268 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Instituto de Investigacion Sanitaria La Fe |
| Condition | Ovarian Neoplasms |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2025-11-10 |
| Primary Completion | 2028-06 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 200 participants in total. It began in 2025-11-10 with a primary completion date of 2028-06.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06963268 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovarian Neoplasms. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06963268 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 200 participants.
Is NCT06963268 currently recruiting?
Yes, NCT06963268 is actively recruiting participants. Contact the research team at investigacion_clinica@iislafe.es for enrollment information.
Where is the NCT06963268 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT06963268 clinical trial?
NCT06963268 is sponsored by Instituto de Investigacion Sanitaria La Fe. The trial plans to enroll 200 participants.