Sentinel Node Mapping in Women With Cervical and Endometrial Cancer (SENTIREC I)

University of Southern Denmark (SDU)

Status: Completed

Conditions: Uterine Cervical Neoplasms; Uterine Neoplasms

Study type: Observational

Funder types: Other

Identifiers

NCT02825355

SDUSF12015163 1 (198)

Details and patient eligibility

About

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.

Enrollment: 512 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

512 participants in 2 patient groups

Patients with cervical cancer

Description:

All patients receive sentinel node mapping as the conventional treatment.

Patients with endometrial cancer

Description:

All patients receive sentinel node mapping as the conventional treatment.