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.
Study 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.
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
—
Healthy volunteers
No
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.
Primary outcome measure(s)
Negative predictive value of the sentinel lymph node technique. — Postoperative (30 days +/- 10 days) 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.
Trial sites (1)
Facility
City
Region
Status
Hospital Universitario y Politécnico La Fe
Valencia
Valencia
Recruiting
More Instituto de Investigacion Sanitaria La Fe trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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