Clinical trial NCT06963268: Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
Official title: Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE3
Conditions: Ovarian Neoplasms
Keywords: Sentinel Node Technique
Lead sponsor: Instituto de Investigacion Sanitaria La Fe
Sponsor class: OTHER
Collaborators: name: Hospital Universitario La Fe
name: Hospital Clinic of Barcelona
name: Hospital Universitario 12 de Octubre
name: Hospital Universitario La Paz
name: Hospital General Universitario Gregorio Marañon
name: Quirón Madrid University Hospital
name: Hospital of Navarra
name: Hospital Son Espases
name: Hospital Universitari de la Vall de Hebron
name: Hospital Universitario Fundación Jiménez Díaz
name: Clinica Universidad de Navarra, Universidad de Navarra
First posted: 2025-05-08
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Controlled, prospective, descriptive and not randomized
Primary purpose: DIAGNOSTIC

Brief 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 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.

Primary outcomes:
measure: Negative predictive value of the sentinel lymph node technique.
timeFrame: Postoperative (30 days +/- 10 days)
Secondary outcomes:
measure: Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy
timeFrame: Postoperative (30 days +/- 10 days).
measure: Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection
timeFrame: Intraoperative and postoperative (30 days +/- 10 days).
measure: Sample Characterization
timeFrame: Baseline visit and Intraoperative
measure: Characterize Sentinel Lymph Node Technique Based On Site of Drug Injection
timeFrame: Intraoperative and postoperative (30 days +/- 10 days).
measure: Determine Sentinel Lymph Node Procedure Rate
timeFrame: Intraoperative and postoperative (30 days +/- 10 days).
measure: Determine the rate of "empty" sentinel lymph node detection.
timeFrame: Postoperative (30 days +/- 10 days).
measure: Determine Pelvic and/or Paraaortic Sentinel Lymph Node Detection Rate
timeFrame: Intraoperative and postoperative (30 days +/- 10 days).
measure: Identify the anatomical location of the sentinel lymph nodes.
timeFrame: Intraoperative and postoperative (30 days +/- 10 days).
measure: Determine the number of detected lymph nodes.
timeFrame: Intraoperative and postoperative (30 days +/- 10 days).
measure: Rate of overstaging with ultrastaging.
timeFrame: Postoperative (30 days +/- 10 days).
measure: Complications related to the sentinel lymph node technique
timeFrame: Intraoperative and postoperative (30 days +/- 10 days).
measure: Complications related to lymphadenectomy.
timeFrame: Intraoperative and postoperative (30 days +/- 10 days).
Other outcomes:
Locations:
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico La Fe
Study officials:
References: