Sentinel Node Mapping in Women With Cervical and Endometrial Cancer

Uterine Cervical Neoplasms Clinical Trial

— SENTIREC I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02825355
• Other study ID #: SDUSF12015163 1 (198)
• Status: Completed
• Start date: February 27, 2017
• Est. completion date: May 1, 2022

Study information

• Verified date: May 2022
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 512
• Est. completion date: May 1, 2022
• Est. primary completion date: May 1, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Neoplasms
• Neoplasms
• Uterine Cervical Neoplasms
• Uterine Neoplasms

Locations

Country	Name	City	State
Denmark	Rigshospitalet	Copenhagen
Denmark	Herlev Hospital	Herlev
Denmark	Odense University Hospital	Odense

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern Denmark	Danish Cancer Society, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of lymphedema	Incidence of lymphedema will be assessed using patient reported outcome measures.	3 years
Primary	Severity of lymphedema	Severity of lymphedema will be assessed using patient reported outcome measures.	3 years
Secondary	Detection rate of sentinel lymph node	Detection of sentinel lymph node per patient, per heme-pelvis and bilaterally	2 years
Secondary	Mapping of SLN in different types of lymph node stations	Mapping of SLN in areas outside the normal area of pelvic lymphadenectomy	2 years