A multicentre prospective comparative study, comparing the use of various markers (magnetic marker Magseed, iodine seed 125I, carbon suspension) for marking a pathological lymph node in patients with breast carcinoma prior to neoadjuvant therapy and subsequent surgical treatment consisting of targeted axillary dissection.
There are two basic aims of the study 1. Prospective comparison of the reliability and accuracy of individual markers used for marking of a pathological axillary lymph node with subsequent targeted axillary dissection. 2. Comparison of the number of complications during localizing and detection of individual markers and postoperative complications. In individual collaborating centers, these markers are commonly used in clinical practice for marking of a pathological lymph node in patients with breast carcinoma. The usual standard of practice and treatment will not be changed in any way; the patients will only be prospectively followed. The study will bring an answer to the question of which marker is the best for marking lymph nodes. Apart from the basic demographic and other data (patient age, side of the body, size and characteristics of the tumor (typing, grading, staging), type and time of surgery, the incidence of complications during implantation or detection of the marker, number of lymph nodes, complications after surgery, and the final histological findings, also the following outcome measures will be observed: * depth of marker implantation (measured in mm) * marker migration (measured in mm) * success-rate of resection of the marked lymph node - assessment, whether the lymph node was removed (yes/no) using the respective marker, expressed in percent of successful removal for the respective marker * time from localizing the pathological lymph node using the marker to surgery (measured n days)
Study Type
OBSERVATIONAL
Enrollment
100
The surgical treatment procedure of targeted axillary dissection performed in patients in whom the pathological lymph nodes have been marked using the examined and compared markers (magnetic marker Magseed, iodine seed 125I, carbon suspension)
Silesian Hospital in Opava
Opava, Moravian-Silesian Region, Czechia
University Hospital Ostrava
Ostrava, Moravian-Silesian Region, Czechia
Institute for the Care of Mother and Child, Prague, Czech Republic
Prague, Prague, Czechia
Masaryk Memorial Cancer Institute
Brno, South Moravian, Czechia
Depth of marker implantation
The depth of marker implantation will be assessed and measured in millimetres
Time frame: During surgery/intervention
Marker migration
Marker migration will be assessed and measured in millimetres
Time frame: During surgery/intervention
Success-rate of resection of the marked lymph node
Assessment, whether the lymph node was removed (yes/no) using the respective marker, expressed in percent of successful removal for the respective marker.
Time frame: 1 month
Time from localizing the pathological lymph node using the marker to surgery
The time from localizing the pathological lymph node using the marker to surgery will be analysed and measured in days
Time frame: 1 month
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EUC Clinic in Zlín
Zlín, Zlín, Czechia