Validating sentinel lymph node mapping for early-stage ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional study applies a sentinel lymph node (SLN) mapping technique during staging surgery for apparent FIGO I-II epithelial ovarian cancer. Patients receive SLN identification using standard tracers, with findings compared to systematic pelvic and paraaortic lymphadenectomy to determine diagnostic accuracy and negative predictive value. The study will track safety, complication rates, and hospitalization length to see if the SLN approach lowers surgical morbidity. Results aim to show whether SLN mapping can reliably replace full lymphadenectomy in selected early-stage patients.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitario y Politécnico La Fe
  Valencia, Valencia, Spain Recruiting

Study contacts

• Study coordinator: Mónica Cebrián Coordinator Clinical Research Area
• Email: investigacion_clinica@iislafe.es
• Phone: +34961246731

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.