Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
NCT ID: NCT06963268
Last Updated: 2025-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2025-11-10
2028-06-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
FEMALE
No
Sponsors
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Hospital Universitario La Fe
OTHER
Hospital Clinic of Barcelona
OTHER
Hospital Universitario 12 de Octubre
OTHER
Hospital Universitario La Paz
OTHER
Hospital General Universitario Gregorio Marañon
OTHER
Quirón Madrid University Hospital
OTHER
Hospital of Navarra
OTHER
Hospital Son Espases
OTHER
Hospital Universitari de la Vall de Hebron
UNKNOWN
Hospital Universitario Fundación Jiménez Díaz
OTHER
Clinica Universidad de Navarra, Universidad de Navarra
OTHER
Instituto de Investigacion Sanitaria La Fe
OTHER
Responsible Party
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Locations
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Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain
Countries
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Central Contacts
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Mónica Cebrián Coordinator Clinical Research Area
Role: CONTACT
Phone: +34961246731
Email: [email protected]
Facility Contacts
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Mónica Cebrián Coordinator Clinical Research Area
Role: primary
Other Identifiers
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SENTOV II
Identifier Type: -
Identifier Source: org_study_id