Marker Technique Comparison in Targeted Axillary Dissection

Breast Cancer Clinical Trial

— MALLORCA  

Official 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05173415
• Other study ID #: 021-013772
• Status: Recruiting
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 2025

Study information

• Verified date: September 2023
• Source: Brust-Zentrum AG
• Contact: Constanze Elfgen, Dr.med.
• Phone: +41 44 533 81 00
• Email: constanze.elfgen[@]brust-zentrum.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Sirius Pintution
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
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.

Locations

Country	Name	City	State
Switzerland	Brustzentrum Kantonsspital Baden	Baden	Aargau
Switzerland	Brustzentrum Bern Biel	Bern
Switzerland	Brustzentrum Ostschweiz	Saint Gallen
Switzerland	Brust-Zentrum Zürich AG	Zurich

Sponsors (1)

Lead Sponsor	Collaborator
Constanze Elfgen

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Incidence of intraoperative complications and postoperative adverse events.	The safety outcome variables include allergic reactions, bleeding, bruising, dislocation, pain, scar, and very rare events such as lymphedema or neurologic damages.	6 months
Primary	To compare clinical manageability, efficacy, safety, and sufficiency of two lymph node marking systems (HydroMark Clip versus Sirius Pintuition)	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").	6 months
Secondary	Failure rate (unsuccessful localisation of the marked lymph node)	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.	6 months
Secondary	Incidence of complications of both methods used for lymph node marking.	This outcome measures the safety of both methods during the implantation of the randomised marker, excision surgery of the lymph node and postoperative period.	6 months
Secondary	Adverse events	This outcome assesses adverse events caused by either lymph node marker during implantation and excision of the marker and within the postoperative period.	6 months
Secondary	Satisfaction of the performing Surgeon concerning the handling of the marking technique documented in the Case Report Form.	This outcome measures the satisfaction of the performing surgeon concerning the handling of the lymph node marking technique during implantation and excision surgery.	6 months