Status:
RECRUITING
Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
Lead Sponsor:
Instituto de Investigacion Sanitaria La Fe
Collaborating Sponsors:
Hospital Universitario La Fe
Hospital Clinic of Barcelona
Conditions:
Ovarian Neoplasms
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
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 objecti...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 10 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06963268
Start Date
November 10 2025
End Date
June 1 2028
Last Update
December 19 2025
Active Locations (1)
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1
Hospital Universitario y Politécnico La Fe
Valencia, Valencia, Spain, 46026