Marker Technique Comparison in Targeted Axillary Dissection (MALLORCA)
Breast Cancer
About this trial
This is an interventional diagnostic trial for Breast Cancer
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.
Exclusion Criteria:
- Not fulfilling inclusion criteria
Sites / Locations
- Brustzentrum Kantonsspital BadenRecruiting
- Brustzentrum Bern BielRecruiting
- Brustzentrum OstschweizRecruiting
- Brust-Zentrum Zürich AGRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Sirius Pintution Group
HydroMARK(C) Clip Group
Patients who are randomized for the Pintution Clip will receive a preoperative ultrasound-guided marking in the axillary lymph nodes that indicate for surgical removal. Surgical procedure is standardized with a handheld probe leading intraoperatively to the marked lymph node and its excision. Successful detection, time of the procedure (beginning of localization intervention to completed lymph node excision), and intra- and postoperative complication rate will be measured. Intra- and postoperative complications are adverse events during the surgery or within 48 hours after the surgery.
Patients who are randomized for the standard clip will receive a preoperative ultrasound-guided marking with HydroMark® Clip in the axillary lymph node that indicate for surgical removal. Surgical procedure is standardized with intraoperative ultrasound-guided wire-localization of the clip and lymph node excision. Successful detection, time of the procedure (beginning of localization intervention to completed lymph node excision), and intra- and postoperative complication rate will be measured. Intra- and postoperative complications are adverse events during the surgery or within 48 hours after the surgery.