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

Phase 3

Not yet recruiting

• Conditions: Ovarian Neoplasms

• Registration Number: NCT06963268
• Lead Sponsor: Instituto de Investigacion Sanitaria La Fe

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-04
• Study First Submitted: 2025-04-30
• Study First Submitted QC: 2025-04-30
• Last Update Submitted: 2025-04-30
• Study First Posted: 2025-05-08
• Last Update Posted: 2025-05-08
• Study Start: 2025-06
• Primary Completion: 2028-06
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
Determine Sentinel Lymph Node Procedure Rate	Intraoperative and postoperative (30 days +/- 10 days).	Determine the sentinel lymph node procedure rate.
Complications related to lymphadenectomy.	Intraoperative and postoperative (30 days +/- 10 days).	Complications related to lymphadenectomy.
Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy	Postoperative (30 days +/- 10 days).	Evaluate the degree of concordance (sensitivity, specificity, positive predictive value, and diagnostic accuracy) between the sentinel lymph node technique and pelvic/aortic lymphadenectomy (Gold Standard) for detecting lymph node metastasis.
Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection	Intraoperative and postoperative (30 days +/- 10 days).	Characterize the sentinel lymph node technique for detecting lymph node metastasis using pelvic/aortic lymphadenectomy as the Gold Standard in terms of sensitivity, specificity, positive and negative predictive value, positive and negative likelihood ratios, and effectiveness.
Sample Characterization	Baseline visit and Intraoperative	Characterize the sample (through collection of baseline characteristics, medical history, tumor markers, intraoperative findings, surgical procedures, and immediate admission data).
Characterize Sentinel Lymph Node Technique Based On Site of Drug Injection	Intraoperative and postoperative (30 days +/- 10 days).	Characterize the sentinel lymph node technique for detecting lymph node metastasis based on the site of drug injection, using lymphadenectomy as the Gold Standard, in terms of sensitivity, specificity, positive and negative predictive value, positive and negative likelihood ratios, and effectiveness.
Determine the rate of "empty" sentinel lymph node detection.	Postoperative (30 days +/- 10 days).	Determine the rate of "empty" sentinel lymph node detection.
Determine Pelvic and/or Paraaortic Sentinel Lymph Node Detection Rate	Intraoperative and postoperative (30 days +/- 10 days).	Determine the detection rate of pelvic and/or paraaortic sentinel lymph nodes.
Identify the anatomical location of the sentinel lymph nodes.	Intraoperative and postoperative (30 days +/- 10 days).	Identify the anatomical location of the sentinel lymph nodes.
Determine the number of detected lymph nodes.	Intraoperative and postoperative (30 days +/- 10 days).	Determine the number of detected lymph nodes.
Rate of overstaging with ultrastaging.	Postoperative (30 days +/- 10 days).	Rate of overstaging with ultrastaging.
Complications related to the sentinel lymph node technique	Intraoperative and postoperative (30 days +/- 10 days).	Complications related to the sentinel lymph node technique.

Trial Locations

Locations (1)

Hospital Universitario y Politécnico La Fe; 🇪🇸 Valencia, Spain