Clinical trial NCT02820506: Sentinel Node Mapping in Women With Endometrial and Cervical Cancer
Official title: Sentinel Node Mapping With Robotic Assisted Near Infra-red Fluorescent Imaging in Women With Cervical and Endometrial Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Uterine Cervical Neoplasms
Uterine Neoplasms
Keywords: robotic surgery procedures
indocyanine green
sentinel lymph node mapping
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
Collaborators: name: Odense University Hospital
name: Danish Cancer Society
First posted: 2016-07-01
Enrollment: 300
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: DIAGNOSTIC

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.


Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity
timeFrame: 2 years
measure: Negative predictive value
timeFrame: 2 years
Secondary outcomes:
measure: Specificity
timeFrame: 2 years
measure: Positive predictive value
timeFrame: 2 years
measure: Prevalence of lymph node metastasis
timeFrame: 2 years
measure: Incidence of lymphedema
timeFrame: 3 years
measure: Severity of lymphedema
timeFrame: 3 years
measure: Quality of life rate
timeFrame: 3 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Herlev
country: Denmark
facility: Herlev Hospital
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Aarhus University Hospital and Aarhus University, Denmark
name: Pernille T Jensen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjornholt SM, Sponholtz SE, Markauskas A, Froding LP, Larsen CR, Fuglsang K, Schledermann D, Mogensen O, Jensen PT. Sentinel lymph node mapping for endometrial and cervical cancer in Denmark. Dan Med J. 2021 Mar 24;68(4):A11200886.