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

Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
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• 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.

Locations
Other Locations
Spain
Hospital Universitario y Politécnico La Fe
RECRUITING
Valencia
Contact Information
Primary
Mónica Cebrián Coordinator Clinical Research Area
investigacion_clinica@iislafe.es
+34961246731
Time Frame
Start Date: 2025-11-10
Estimated Completion Date: 2028-06
Participants
Target number of participants: 200
Treatments
Experimental: Women >18, with confirmed early-stage ovarian cancer, undergoing staging surgery.
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.
Related Therapeutic Areas
Sponsors
Collaborators: Hospital General Universitario Gregorio Marañon, Clinica Universidad de Navarra, Universidad de Navarra, Hospital Clinic of Barcelona, Hospital Universitario 12 de Octubre, Hospital Universitari de la Vall de Hebron, Hospital Universitario La Fe, Hospital Son Espases, Hospital Universitario Fundación Jiménez Díaz, Hospital of Navarra, Hospital Universitario La Paz, Quirón Madrid University Hospital
Leads: Instituto de Investigacion Sanitaria La Fe

This content was sourced from clinicaltrials.gov