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

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 30, 2025

Primary Completion Date

June 30, 2028

Study Completion Date

June 30, 2028

Conditions
Ovarian Neoplasms
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.

Trial Locations (1)

46026

Hospital Universitario y Politécnico La Fe, Valencia

All Listed Sponsors
collaborator

Hospital Universitario La Fe

OTHER

collaborator

Hospital Clinic of Barcelona

OTHER

collaborator

Hospital Universitario 12 de Octubre

OTHER

collaborator

Hospital Universitario La Paz

OTHER

collaborator

Hospital General Universitario Gregorio Marañon

OTHER

collaborator

Quirón Madrid University Hospital

OTHER

collaborator

Hospital of Navarra

OTHER

collaborator

Hospital Son Espases

OTHER

collaborator

Hospital Universitari de la Vall de Hebron

UNKNOWN

collaborator

Hospital Universitario Fundación Jiménez Díaz

OTHER

collaborator

Clinica Universidad de Navarra, Universidad de Navarra

OTHER

lead

Instituto de Investigacion Sanitaria La Fe

OTHER