Sentinel Node Mapping in Women With Endometrial and Cervical Cancer

Study Overview
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Brief Summary
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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.

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

Conditions
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Uterine Neoplasms, Uterine Cervical Neoplasms

Intervention / Treatment
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* Procedure: SLN mapping and removal of PET-positive lymph nodes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: High risk endometrial cancer<br>Patients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy. | Procedure: SLN mapping and removal of PET-positive lymph nodes<br>* Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes<br>|
| Other: Cervical cancer tumor size 2-4 cm<br>Patients will receive sentinel node mapping, followed by removal of PET-positive lymph nodes and finally conventional pelvic lymphadenectomy. | Procedure: SLN mapping and removal of PET-positive lymph nodes<br>* Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value | Negative 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 | 
| 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 | 
| 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 | 
| Prevalence of lymph node metastasis | Prevalence of lymph node metastasis in the pelvis and paraaortic area | 2 years | 
| Incidence of lymphedema | Using patient reported outcome measures | 3 years | 
| Severity of lymphedema | Using patient reported outcome measures | 3 years | 
| Quality of life rate | Using patient reported outcome measures | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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robotic surgery procedures, indocyanine green, sentinel lymph node mapping