Sentinel Node Mapping in Women With Cervical and Endometrial Cancer

NCT02825355CompletedOBSERVATIONAL

Summary

This study aims to evaluate the effect of SLN mapping on the incidence and severity of lymphedema in women with early stage cervical and endometrial cancer.

Key Facts

Lead Sponsor

University of Southern Denmark

Enrollment

512

Start Date

2017-02-27

Completion Date

2022-05-01

Study Type

OBSERVATIONAL

Official Title

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

Conditions

Uterine Cervical NeoplasmsUterine Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* Study IA: Cervical carcinoma, FIGO stage IB1, cervical tumour size \< 2 cm
* Study IB: Endometrial adenocarcinoma, presumed FIGO stage I, low- and intermediate risk: Type 1 grade 1 + 2, \> 50% myometrial invasion

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

Incidence of lymphedema

Incidence of lymphedema will be assessed using patient reported outcome measures.

Time frame: 3 years

Severity of lymphedema

Severity of lymphedema will be assessed using patient reported outcome measures.

Time frame: 3 years

Secondary Outcomes

Detection rate of sentinel lymph node

Detection of sentinel lymph node per patient, per heme-pelvis and bilaterally

Time frame: 2 years

Mapping of SLN in different types of lymph node stations

Mapping of SLN in areas outside the normal area of pelvic lymphadenectomy

Time frame: 2 years

Locations

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.

Sentinel Node Mapping in Women With Cervical and Endometrial Cancer