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

Phase 3RecruitingNCT06963268

Instituto de Investigacion Sanitaria La Fe200 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

200

Conditions

Ovarian Neoplasms

Interventions

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.

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Negative predictive value of the sentinel lymph node technique.

To determine the negative predictive value of the sentinel lymph node technique for detecting lymph node metastases, using pelvic/aortic lymphadenectomy as the Gold Standard.

Time frame: Postoperative (30 days +/- 10 days)

Secondary Outcomes

Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy

Evaluate the degree of concordance (sensitivity, specificity, positive predictive value, and diagnostic accuracy) between the sentinel lymph node technique and pelvic/aortic lymphadenectomy (Gold Standard) for detecting lymph node metastasis.

Time frame: Postoperative (30 days +/- 10 days).

Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection

Characterize the sentinel lymph node technique for detecting lymph node metastasis using pelvic/aortic lymphadenectomy as the Gold Standard in terms of sensitivity, specificity, positive and negative predictive value, positive and negative likelihood ratios, and effectiveness.