Sentinel Node Mapping in Women With Endometrial and Cervical Cancer

Not Applicable

Active, not recruiting

• Conditions: Uterine Cervical Neoplasms; Uterine Neoplasms
• Interventions: Procedure: SLN mapping and removal of PET-positive lymph nodes

• Registration Number: NCT02820506
• Lead Sponsor: University of Southern Denmark

Brief Summary

The aim of the study is to evaluate the feasibility of applying the SLN mapping technique in combination with FDG-PET/CT imaging in women with high-risk histology endometrial cancer and in patients with cervical cancer tumour size 2-4 cm.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-28
• Study First Posted: 2016-07-01
• Study Start: 2017-02-27
• Primary Completion: 2023-01-31
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Study IIA: Patients with cervical cancer, FIGO IB1, tumor size 2-4 cm
• Study IIB: Patients with high risk endometrial cancer, presumed FIGO I, type 1 histology grade 3 Endometrioid adenocarcinoma or type 2 histology (serous-, clearcel-, carcinosarcoma or undifferentiated adenocarcinoma.

Exclusion Criteria

• Prior PL
• Known allergy towards ICG and/or iodine (ICG contains 5% sodium iodine)
• Women included in other studies affecting outcome-measures of the present study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High risk endometrial cancer	SLN mapping and removal of PET-positive lymph nodes	Patients will receive sentinel node mapping, removal of PET-positive lymph nodes and finally conventional pelvic and paraaortic lymphadenectomy.
Cervical cancer tumor size 2-4 cm	SLN mapping and removal of PET-positive lymph nodes	Patients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy.

Primary Outcome Measures

Name	Time	Method
Sensitivity	2 years	Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes
Negative predictive value	2 years	Negative predictive value of sentinel lymph node mapping algorithm, and a sentinel lymph node mapping algorithm including removal of PET-positive lymph nodes

Secondary Outcome Measures

Name	Time	Method
Positive predictive value	2 years	Positive predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Quality of life rate	3 years	Using patient reported outcome measures
Specificity	2 years	Specificity of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
Incidence of lymphedema	3 years	Using patient reported outcome measures
Severity of lymphedema	3 years	Using patient reported outcome measures
Prevalence of lymph node metastasis	2 years	Prevalence of lymph node metastasis in the pelvis and paraaortic area

Trial Locations

Locations (4)

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Herlev Hospital; 🇩🇰 Herlev, Denmark

Rigshospitalet; 🇩🇰 Copenhagen, Denmark

Odense University Hospital; 🇩🇰 Odense, Denmark