Actively Recruiting

Phase 3
Age: 18Years +
FEMALE
NCT06963268

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

Led by Instituto de Investigacion Sanitaria La Fe · Updated on 2025-12-19

200

Participants Needed

1

Research Sites

133 weeks

Total Duration

On this page

Sponsors

I

Instituto de Investigacion Sanitaria La Fe

Lead Sponsor

H

Hospital Universitario La Fe

Collaborating Sponsor

AI-Summary

What this Trial Is 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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent before any trial procedure
  • Female, 18 years or older at inclusion
  • Histopathological diagnosis of malignant ovarian tumor in early stage FIGO I-II, planned for staging surgery
  • Suspected malignant ovarian tumor in early stage FIGO I-II undergoing exploratory laparotomy and biopsy, followed by staging surgery if positive
Not Eligible

You will not qualify if you...

  • Failure to give or revocation of informed consent
  • Under 18 years old at inclusion
  • Previous vascular surgery on aorta, vena cava, or pelvic vessels
  • Previous pelvic or paraaortic lymphatic surgery
  • History of lymphoma
  • Previous abdomino-pelvic tumor
  • Allergy to Tc99 or ICG
  • Pregnancy or breastfeeding

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, Spain, 46026

Actively Recruiting

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Research Team

M

Mónica Cebrián Coordinator Clinical Research Area

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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