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

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.

Conditions

• Ovarian Neoplasms

Interventions

PROCEDURE

Sentinel 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.

Sponsors & Collaborators

• Hospital Universitario La Fe

  collaborator OTHER

• Hospital Clinic of Barcelona

  collaborator OTHER

• Hospital Universitario 12 de Octubre

  collaborator OTHER

• Hospital Universitario La Paz

  collaborator OTHER

• Hospital General Universitario Gregorio Marañon

  collaborator OTHER

• Quirón Madrid University Hospital

  collaborator OTHER

• Hospital of Navarra

  collaborator OTHER

• Hospital Son Espases

  collaborator OTHER

• Hospital Universitari de la Vall de Hebron

  collaborator UNKNOWN

• Hospital Universitario Fundación Jiménez Díaz

  collaborator OTHER

• Clinica Universidad de Navarra, Universidad de Navarra

  collaborator OTHER

• Instituto de Investigacion Sanitaria La Fe

  lead OTHER

Study Design

Allocation

NA

Purpose

DIAGNOSTIC

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-11-10

Primary Completion

2028-06-30

Completion

2028-06-30

Countries

• Spain

Study Locations