RecruitingPhase 3NCT06963268

Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)

Sponsor

Instituto de Investigacion Sanitaria La Fe

Enrollment

200 participants

Start Date

Nov 10, 2025

Study Type

INTERVENTIONAL

Conditions

Ovarian Neoplasms

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a surgical technique called sentinel lymph node biopsy in women with early-stage ovarian cancer. The goal is to see if surgeons can identify the first lymph nodes that cancer might spread to, potentially reducing the need to remove large numbers of lymph nodes. **You may be eligible if...** - You are female, aged 18 or older - You have been diagnosed with ovarian cancer (any type of epithelial cancer) in an early stage (FIGO stage I or II) - You are scheduled for staging surgery or exploratory surgery for a suspected early-stage ovarian tumor - You have signed a consent form before any study procedures begin **You may NOT be eligible if...** - You have advanced-stage ovarian cancer beyond FIGO stage II - You have already received chemotherapy or radiation for this cancer - You do not meet surgical eligibility requirements Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDURESentinel Node Technique

A 0.2 ml (27 mBq) dose of 99mTc and 0.5 ml (1.25 mg/ml) of ICG is injected subperitoneally in the dorsal or ventral side of the pelvic infundibulum stump, and 0.2 ml (27 mBq) of 99mTc and 1 ml (1.25 mg/ml) of ICG intracervically. Sentinel nodes are located using the auditory signal from the gamma probe and visually via ICG staining with an infrared light system. After 30 minutes, all identified nodes are removed. Deferred histology applies ultra-staging for negative or micrometastatic nodes.