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

NCT06963268 | Recruiting Phase 3

• 1 other identifier: SENTOV II
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Ovarian Neoplasms

Keywords

Sentinel Node Technique

Outcome Measures

Primary Outcomes (1)

• Negative predictive value of the sentinel lymph node technique.

  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.

  Postoperative (30 days +/- 10 days)

Secondary Outcomes (12)

• Concordance of Sentinel Lymph Node Technique vs. Lymphadenectomy

  Postoperative (30 days +/- 10 days).

• Characterize Sentinel Lymph Node Technique vs. Lymphadenectomy for Metastasis Detection

  Intraoperative and postoperative (30 days +/- 10 days).

• Sample Characterization

  Baseline visit and Intraoperative

• Characterize Sentinel Lymph Node Technique Based On Site of Drug Injection

  Intraoperative and postoperative (30 days +/- 10 days).

• Determine Sentinel Lymph Node Procedure Rate

  Intraoperative and postoperative (30 days +/- 10 days).

Study Arms (1)

Women >18, with confirmed early-stage ovarian cancer, undergoing staging surgery.

EXPERIMENTAL

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.

Procedure: Sentinel Node Technique

Interventions

Sentinel Node Technique PROCEDURE

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.

Women >18, with confirmed early-stage ovarian cancer, undergoing staging surgery.

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent prior to the performance of any procedure related to the clinical trial.
• 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.

You may not qualify if:

• Failure to obtain informed consent or revocation of informed consent.
• 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.

Sponsors & Collaborators

• Instituto de Investigacion Sanitaria La Fe: lead
• Hospital Universitario La Fe: collaborator
• Hospital Clinic of Barcelona: collaborator
• Hospital Universitario 12 de Octubre: collaborator
• Hospital Universitario La Paz: collaborator
• Hospital General Universitario Gregorio Marañon: collaborator
• Quirón Madrid University Hospital: collaborator
• Hospital of Navarra: collaborator
• Hospital Son Espases: collaborator
• Hospital Universitari de la Vall de Hebron: collaborator
• Hospital Universitario Fundación Jiménez Díaz: collaborator
• Clinica Universidad de Navarra, Universidad de Navarra: collaborator

Study Sites (1)

Hospital Universitario y Politécnico La Fe

Valencia, Valencia, 46026, Spain

RECRUITING

Related Publications (1)

• 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. 2025 Nov 21:102821. doi: 10.1016/j.ijgc.2025.102821. Online ahead of print.

  PMID: 41763980 DERIVED

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Mónica Cebrián Coordinator Clinical Research Area

CONTACT

+34961246731; investigacion_clinica@iislafe.es

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Controlled, prospective, descriptive and not randomized

Study Record Dates

• First Submitted: April 30, 2025
• First Posted: May 8, 2025
• Study Start: November 10, 2025
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: December 19, 2025

Record last verified: 2025-04

Locations

ES (1)