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Sentinel Node Mapping in Women With Endometrial and Cervical Cancer

NCT02820506UNKNOWNNAINTERVENTIONAL

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.

Key Facts

Lead Sponsor

University of Southern Denmark

Enrollment

300

Start Date

2017-02-27

Completion Date

2023-01-31

Study Type

INTERVENTIONAL

Official Title

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

Interventions

SLN mapping and removal of PET-positive lymph nodes

Conditions

Uterine Cervical NeoplasmsUterine Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Sensitivity

Sensitivity of sentinel lymph node mapping compared to the sensitivity of sentinel lymph node mapping combined with removal of PET-positive lymph nodes

Time frame: 2 years

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

Time frame: 2 years

Secondary Outcomes

Specificity

Specificity of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes

Time frame: 2 years

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

Time frame: 2 years

Prevalence of lymph node metastasis

Prevalence of lymph node metastasis in the pelvis and paraaortic area

Time frame: 2 years

Incidence of lymphedema

Using patient reported outcome measures

Time frame: 3 years

Severity of lymphedema

Using patient reported outcome measures

Time frame: 3 years

Quality of life rate

Using patient reported outcome measures

Time frame: 3 years

Locations

Aarhus University Hospital, Aarhus, Denmark

Rigshospitalet, Copenhagen, Denmark

Herlev Hospital, Herlev, Denmark

Odense University Hospital, Odense, Denmark

Linked Diseases

Uterine Cervical Neoplasms

Uterine Cervical Neoplasms — a type of gynecological cancer.

Uterine Neoplasms

Uterine Neoplasms — a type of gynecological cancer.