Skip to main content
OpenTrials
Completed

NCT Number: NCT05173415

Marker Technique Comparison in Targeted Axillary Dissection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Brustzentrum Kantonsspital Baden, Baden, Canton of Aargau, Switzerland

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sirius Pintution

Device

The intervention studies a metal Clip (Sirius Pintution) to localize axillary lymph nodes during TAD. Intraoperative localization of the lymph node will be conducted using a hand-held probe identifying the clip.

HydroMARK (C) Clip

Device

The control intervention is 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.

Primary outcomes

  1. To compare clinical manageability, efficacy, safety, and sufficiency of two lymph node marking systems (HydroMark Clip versus Sirius Pintuition)

    Time frame: 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 outcomes

  1. Failure rate (unsuccessful localisation of the marked lymph node)

    Time frame: 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.

  2. Incidence of complications of both methods used for lymph node marking.

    Time frame: 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.

  3. Adverse events

    Time frame: 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.

  4. Satisfaction of the performing Surgeon concerning the handling of the marking technique documented in the Case Report Form.

    Time frame: 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.

Other outcomes

  1. Incidence of intraoperative complications and postoperative adverse events.

    Time frame: 6 months

    The safety outcome variables include allergic reactions, bleeding, bruising, dislocation, pain, scar, and very rare events such as lymphedema or neurologic damages.

Sponsors and collaborators

Lead sponsor

Constanze Elfgen

Other

Registry information

Official study title

MALLORCA - Trial (Surgical MArker LocaLisation OR Clip and Wire Application for Targeted Axillary Dissection in Node Positive Breast Cancer Patients) A Prospective, Randomized Multi-centre Trial.

Acronym: MALLORCA

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Dec 30, 2021
Registry last updated
Feb 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.