Clinical trial NCT05173415: Marker Technique Comparison in Targeted Axillary Dissection
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Brust-Zentrum AG
Sponsor class: OTHER
First posted: 2021-12-30
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A prospective, randomized multi-centre trial
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: To compare clinical manageability, efficacy, safety, and sufficiency of two lymph node marking systems (HydroMark Clip versus Sirius Pintuition)
timeFrame: 6 months
Secondary outcomes:
measure: Failure rate (unsuccessful localisation of the marked lymph node)
timeFrame: 6 months
measure: Incidence of complications of both methods used for lymph node marking.
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
measure: Satisfaction of the performing Surgeon concerning the handling of the marking technique documented in the Case Report Form.
timeFrame: 6 months
Other outcomes:
measure: Incidence of intraoperative complications and postoperative adverse events.
timeFrame: 6 months
Locations:
city: Baden
country: Switzerland
facility: Brustzentrum Kantonsspital Baden
state: Aargau
city: Bern
country: Switzerland
facility: Brustzentrum Bern Biel
city: Saint Gallen
country: Switzerland
facility: Brustzentrum Ostschweiz
city: Zurich
country: Switzerland
facility: Brust-Zentrum Zürich AG
Study officials:
affiliation: Brust-Zentrum AG
name: Constanze Elfgen, Dr.med.
role: PRINCIPAL_INVESTIGATOR
References: