Related Experiment Video
Updated: May 5, 2026
An Orthotopic Model of Serous Ovarian Cancer in Immunocompetent Mice for in vivo Tumor Imaging and Monitoring of Tumor Immune Responses
Published on: November 28, 2010
Validation of the Sentinel Lymph Node Technique in Early-stage Ovarian Cancer (SENTOV II)
Víctor Lago1, Iria Rey1, Berta Diaz-Feijoo2
1Gynecologic Oncology Unit, University Hospital La Fe, Valencia, Spain; Health Research Institute Hospital La Fe (IIS La Fe), Valencia, Spain.
Background:
Pelvic and para-aortic lymphadenectomy remains the standard procedure for nodal staging in apparent early-stage ovarian cancer, but it is associated with considerable morbidity and lacks clear evidence of improving survival. Sentinel lymph node mapping may offer a less invasive alternative while still enabling accurate upstaging in a sub-set of patients with occult lymph node metastasis.
Primary Objective:
This study aims to evaluate the negative predictive value of the sentinel lymph node technique for detecting lymphatic metastases in early-stage ovarian cancer compared with systematic pelvic and para-aortic lymphadenectomy (gold standard).
Study Hypothesis:
The sentinel lymph node technique is non-inferior to systematic lymphadenectomy for detecting lymphatic metastasis.
Trial Design:
This is a multi-center phase III clinical trial. Eligible patients with confirmed early-stage ovarian cancer will undergoing sentinel lymph node mapping and a subsequently complete staging surgery, including systematic lymphadenectomy. The concordance between both methods will be analyzed.
Major Inclusion/Exclusion Criteria:
Inclusion: Women aged ≥18 years, with histologically confirmed epithelial ovarian malignancy in apparent International Federation of Gynecology and Obstetrics I to II stage, planned for staging surgery either at the time of initial surgery (after intra-operative frozen section confirmation) or after a deferred histologic diagnosis.
Exclusion:
Age <18 years, previous vascular or lymphatic pelvic/aortic surgery, previous lymphoma or abdominopelvic tumors, allergy to Technetium-99m or indocyanine green, pregnancy/lactation.
Primary Endpoint:
Negative predictive value of the sentinel lymph node technique compared to systematic lymphadenectomy for lymph node metastasis.
Sample Size:
The planned sample size is 100 patients with negative sentinel lymph node results to ensure adequate statistical power (80%) to detect a negative predictive value for the sentinel lymph node technique above 95%. An interim analysis will be performed once 50% of the recruitment has been reached to adjust the exact total sample size. Recruitment period is estimated at 24 to 36 months in 11 high-volume Spanish centers.
Estimated Dates For Completing Accrual And Presenting Results:
Patient accrual: November 2025 to November 2028.
Final Results Expected:
January 2029.
Trial Registration:
NCT06963268.
More Related Videos
Related Concept Videos
02:07Tumor Progression
Colon cancer is one of the best-documented examples of tumor progression. Early mutation in the APC gene in colon cells causes a small growth on the colon wall called a polyp. With time, this polyp grows into a benign, pre-cancerous tumor. Further...
01:05Cancer-Critical Genes II: Tumor Suppressor Genes
When the function of certain critical genes, especially those involved in cell cycle regulation and cell growth signaling cascades, gets disrupted, it upsets the cell cycle progression. Such cells with unchecked cell cycles start proliferating uncontrollably and eventually develop into tumors.
Such genes that act...