Marker Technique Comparison in Targeted Axillary Dissection

Not Applicable

Completed

• Conditions: Breast Cancer

• Registration Number: NCT05173415
• Lead Sponsor: Constanze Elfgen

Brief Summary

Comparison of two methods (Magnetic Marker and standard metal clip) used for localisation and extraction of lymph nodes in Targeted Axillary Dissection (TAD) in patients with breast cancer.This Project will investigate and compare the duration of intervention, detection rate and safety.

The participants will be randomized into two groups of equal size.

Detailed Description

This Project will investigate and compare the duration of intervention, detection rate and safety of two methods (Magnetic Sirius Pintuition Marker and standard metal clip) used for the localisation and extraction of lymph nodes in Targeted Axillary Dissection (TAD).

The participants will be randomized into two groups of equal size. The groups differ in terms of the method used to mark the lymph nodes prior to TAD. One group will receive a metal clip (HydroMARK© Clip), which will be localized and extracted during the tailoring surgery. Intraoperative Ultrasound is used to localize the clip. This method is considered as standard practice today.

The second group will receive Metal Clip (Sirius Pintuition) to localize axillary lymph nodes during TAD. Intraoperative localization of the lymph node will be conducted using a hand-held probe.

Successful localization of the lymph node, duration of the intervention (beginning of the localization until successful extraction) and adverse effects will be documented.

Study Timeline

• Study First Submitted: 2021-10-28
• Study First Submitted QC: 2021-12-23
• Study First Posted: 2021-12-30
• Study Start: 2023-08-01
• Primary Completion: 2025-01-31
• Study Completion: 2025-01-31
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-21
• Last Update Posted: 2025-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 40

Inclusion Criteria

• Indication: Patients undergoing lymph node marking before targeted axillary dissection due to suspicious lymph nodes or confirmed lymph node metastasis in breast cancer patients
• Female participants ≥ 18 years of age
• The subject was informed about the project and gave her written informed consent to use her data and samples for this project.
• BMI < 30
• Indication for neoadjuvant chemotherapy

Exclusion Criteria

• Not fulfilling inclusion criteria

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To compare clinical manageability, efficacy, safety, and sufficiency of two lymph node marking systems (HydroMark Clip versus Sirius Pintuition)	6 months	The primary outcome is the efficacy of both methods for lymph node marking. Efficacy is defined as performance time during the surgery from skin incision (either with hooked wire or scalpel) until the complete excision of the marked lymph node. Time is measured in minutes. Manageability includes process performance of the marker insertion (questionnaire for the study physician: "did you experience problems or barriers in inserting the marker?"; "if yes, what kind of?"). Safety is also observed via the questionnaire ("did your patient experience adverse events? bleeding, seroma, (...), other?"). This is also true for sufficiency ("Did you acieve a successful lymph node marking?"; "Have you been able to localize the marker during the surgery or has it been dislocated?"; "Did you manage to remove the marked lymph node including the marker").

Secondary Outcome Measures

Name	Time	Method
Failure rate (unsuccessful localisation of the marked lymph node)	6 months	As a secondary outcome, the failure rate (unsuccessful localisation of the marked lymph node) will be measured. As the failure rate is supposed to be low in general, this topic is not the focus of our study.
Incidence of complications of both methods used for lymph node marking.	6 months	This outcome measures the safety of both methods during the implantation of the randomised marker, excision surgery of the lymph node and postoperative period.
Satisfaction of the performing Surgeon concerning the handling of the marking technique documented in the Case Report Form.	6 months	This outcome measures the satisfaction of the performing surgeon concerning the handling of the lymph node marking technique during implantation and excision surgery.
Adverse events	6 months	This outcome assesses adverse events caused by either lymph node marker during implantation and excision of the marker and within the postoperative period.

Trial Locations

Locations (4)

Brustzentrum Kantonsspital Baden; 🇨🇭 Baden, Aargau, Switzerland

Brustzentrum Bern Biel; 🇨🇭 Bern, Switzerland

Brustzentrum Ostschweiz; 🇨🇭 Saint Gallen, Switzerland

Brust-Zentrum Zürich AG; 🇨🇭 Zurich, Switzerland