Menu
Recruiting NCT06963268

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

Phase III Interventional Ovarian Neoplasms

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sentinel Node Technique.
Who it may be relevant to
Registry conditions: Ovarian Neoplasms. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

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.

Primary outcome measures

  • Negative predictive value of the sentinel lymph node technique. [Time frame: Postoperative (30 days +/- 10 days)]
Secondary outcome measures (12)
  • Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy [Time frame: Postoperative (30 days +/- 10 days).]
  • Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection [Time frame: Intraoperative and postoperative (30 days +/- 10 days).]
  • Sample Characterization [Time frame: Baseline visit and Intraoperative]
  • Characterize Sentinel Lymph Node Technique Based On Site of Drug Injection [Time frame: Intraoperative and postoperative (30 days +/- 10 days).]
  • Determine Sentinel Lymph Node Procedure Rate [Time frame: Intraoperative and postoperative (30 days +/- 10 days).]
  • Determine the rate of "empty" sentinel lymph node detection. [Time frame: Postoperative (30 days +/- 10 days).]
  • Determine Pelvic and/or Paraaortic Sentinel Lymph Node Detection Rate [Time frame: Intraoperative and postoperative (30 days +/- 10 days).]
  • Identify the anatomical location of the sentinel lymph nodes. [Time frame: Intraoperative and postoperative (30 days +/- 10 days).]
  • Determine the number of detected lymph nodes. [Time frame: Intraoperative and postoperative (30 days +/- 10 days).]
  • Rate of overstaging with ultrastaging. [Time frame: Postoperative (30 days +/- 10 days).]
  • Complications related to the sentinel lymph node technique [Time frame: Intraoperative and postoperative (30 days +/- 10 days).]
  • Complications related to lymphadenectomy. [Time frame: Intraoperative and postoperative (30 days +/- 10 days).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

Spain · 1 center
  • Hospital Universitario y Politécnico La Fe — Valencia

Publications

  • Lago V, Rey I, Diaz-Feijoo B, Torrent A, Tejerizo A, Muruzabal JC, Veiga-Fernandez A, Utrilla-Layna J, Chacon E, Angeles MA, Diestro MD, Sainz de la Cuesta R, Padilla-Iserte P, Montero B, Dawid De Vera T, Vera V, Domingo S. Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II). Int J Gynecol Cancer. 2026 Jul;36(7):102821. doi: 10.1016/j.ijgc.2025.102821. Epub 20 PMID 41763980

Identifiers

NCT: NCT06963268 · SENTOV II

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗