Sentinel Node Mapping in Women With Endometrial and Cervical Cancer

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02820506

Acronym

SENTIREC II

Enrollment

300

Registered

2016-07-01

Start date

2017-02-27

Completion date

2026-01-31

Last updated

2024-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cervical Neoplasms, Uterine Neoplasms

Keywords

robotic surgery procedures, indocyanine green, sentinel lymph node mapping

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.

Interventions

PROCEDURESLN mapping and removal of PET-positive lymph nodes

Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

Endometrial cancer, Diagnostic; Assessing the safety of the SLN mapping algorithm. Inclusion is defined by a power calculation: Assuming the true incidence of metastasis is 20% and the sensitivity of the SLN mapping algorithm is 96%. To obtain the conclusion that NPV is larger than 94% using a 95% two-sided exact Clopper-Pearson confidence interval, then 150 women with sentinel lymph node mapping, a FDG/PET-CT and Pelvic- and paraaortic lymph node dissection are needed. Cervical cancer: Study is diagnostic and primarily explorative.

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Prevalence of lymph node metastasis	2 years	Prevalence of lymph node metastasis in the pelvis and paraaortic area
Incidence of lymphedema	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
Quality of life rate	3 years	Using patient reported outcome measures
Severity of lymphedema	3 years	Using patient reported outcome measures
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

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026