Sentinel Node Detection in Cervical Cancer

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03680833

Acronym

SLNcxca

Enrollment

226

Registered

2018-09-21

Start date

2014-06-15

Completion date

2021-12-31

Last updated

2018-09-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sentinel Lymph Node Biopsy

Brief summary

Evaluation of sensitivity of Sentinel lymph nodes for detecting nodal metastases in cervical cancer

Detailed description

Consecutive women with stage 1a2-2a1 cervical cancer scheduled for surgery will be approached for eligibility by defined criteria. Sentinel nodes will be detected by a combined use of Indocyanine green and Tc99 radiocolloid ( first 75 patients) and for the continuation with either the combined use or the best performing of those tracers. Technical success rates, adverse events (related study intervention and overall) sensitivity and negative predictive values will be estimated. An interim analyse will be performed after 34 node positive patients based on the Fleming two stage analyse. The null hypothesis of sensitivity of 85% will be tested against an estimated sensitivity of 95%. At this stage the study may be closed for futility, closed as hull hypothesis is rejected or continued to reach another 28 node positive patients. As a full pelvic lymphadenectomy will be performed after detection of sentinel nodes patient will act ast their own controls.

Interventions

PROCEDURESentinel node detection in cervical cancer

The study intervention is the injection of tracer followed by detection and removal of sentinel lymph nodes

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Intervention model description

prospective cohort study

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Women of age 18 years and older at the time of informed consent. * Women with a pathologically proven cervical carcinoma of any histologic subtype, clinically stage 1a2- 2a1 planned for primary surgery * Absence of any

Design outcomes

Primary

Measure	Time frame	Description
Sentinel node detection in cervical cancer; Sensitivity and negative predictive values for identifying pelvic nodal disease, See detailed study protocol	4-5 years	Detection of Sentinel nodes followed by full pelvic lymphadenectomy

Countries

Sweden

Contacts

Primary ContactJan Persson, ass professor

jan.persson@med.lu.se+46733522080

Backup ContactLinnea Ekdahl, MD

linnea.ekdahl@med.lu.se0739292631

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026