Sentinel Node Mapping in Women With Endometrial and Cervical Cancer

Uterine Cervical Neoplasms Clinical Trial

— SENTIREC II  

Official title:

Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02820506
• Other study ID #: SDUSF12015163 1 (198)1
• Status: Active, not recruiting
• Phase: N/A
• Start date: February 27, 2017
• Est. completion date: January 31, 2026

Study information

• Verified date: February 2024
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: January 31, 2026
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Neoplasms
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Intervention

Procedure:
• SLN mapping and removal of PET-positive lymph nodes
Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev
Denmark	Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Danish Cancer Society, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity	Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes	2 years
Primary	Negative predictive value	Negative predictive value of sentinel lymph node mapping algorithm, and a sentinel lymph node mapping algorithm including removal of PET-positive lymph nodes	2 years
Secondary	Specificity	Specificity of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes	2 years
Secondary	Positive predictive value	Positive predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes	2 years
Secondary	Prevalence of lymph node metastasis	Prevalence of lymph node metastasis in the pelvis and paraaortic area	2 years
Secondary	Incidence of lymphedema	Using patient reported outcome measures	3 years
Secondary	Severity of lymphedema	Using patient reported outcome measures	3 years
Secondary	Quality of life rate	Using patient reported outcome measures	3 years