SENTIREC II: Sentinel Node Mapping in Women With Endometrial and Cervical Cancer

Sponsor

University of Southern Denmark (Other)

Overall Status

Recruiting

CT.gov ID

NCT02820506

Collaborator

Odense University Hospital (Other), Danish Cancer Society (Other)

400

Enrollment

Locations

Arms

74.1

Anticipated Duration (Months)

133.3

Patients Per Site

1.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cervical Neoplasms Uterine Neoplasms	Procedure: SLN mapping and removal of PET-positive lymph nodes	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

400 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Feb 27, 2017

Anticipated Primary Completion Date :

May 1, 2023

Anticipated Study Completion Date :

May 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: High risk endometrial cancer 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 Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes
Other: Cervical cancer tumor size 2-4 cm 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 Sentinel node mapping will be performed, followed by systematic removal og PET/CT positive lymph nodes

Arm

Intervention/Treatment

Other: High risk endometrial cancer

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

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

Other: Cervical cancer tumor size 2-4 cm

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

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

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Negative predictive value [2 years]
Negative predictive value of sentinel lymph node mapping compared to the combination of sentinel lymph node mapping and removal of PET-positive lymph nodes
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
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
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
Severity of lymphedema [3 years]
Using patient reported outcome measures
Quality of life rate [3 years]
Using patient reported outcome measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts 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.