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

Instituto de Investigacion Sanitaria La Fe

Status and phase: Begins enrollment this month; Phase 3

Conditions: Ovarian Neoplasms

Treatments: Procedure: Sentinel Node Technique

Study type: Interventional

Funder types: Other

Identifiers

NCT06963268

SENTOV II

Details and patient eligibility

About

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.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

Women >18, with confirmed early-stage ovarian cancer, undergoing staging surgery.

Experimental group

Description:

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.

Treatment:

Procedure: Sentinel Node Technique