NCT03680833

Sentinel Node Detection in Cervical Cancer

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 226 (estimated)
• Sponsor: Region Skane · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer

Detailed description

Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria. Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers. Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated. An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients. As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.

Conditions

• Sentinel Lymph Node Biopsy

Interventions

Type	Name	Description
PROCEDURE	Sentinel node detection in cervical cancer	The study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes

Timeline

• Start date: 2014-06-15
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2018-09-21
• Last updated: 2018-09-26

Locations

1 site across 1 country: Sweden