Clinical trial · Interventional
Marker Technique Comparison in Targeted Axillary Dissection
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HydroMARK (C) Clip | Device | — | UNRESOLVED |
| Sirius Pintution | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sirius Pintution Group
- description
- 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.
- interventionNames
- Device: Sirius Pintution
- type
- ACTIVE_COMPARATOR
- label
- HydroMARK(C) Clip Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available