Ideal Marker for Targeted Axillary Dissection

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Targeted axillary dissection

• Registration Number: NCT04580251
• Lead Sponsor: University Hospital Ostrava

Brief Summary

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.

Detailed Description

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 Timeline

• Study First Submitted: 2020-10-01
• Study First Submitted QC: 2020-10-01
• Study First Posted: 2020-10-08
• Study Start: 2021-01-01
• Primary Completion: 2023-01-01
• Study Completion: 2023-05-30
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-06
• Last Update Posted: 2023-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

Inclusion Criteria

• diagnosis of breast cancer, confirmed with a biopsy
• indication of neoadjuvant therapy
• biopsy of pathologically enlarged axillary lymph node and marking of the lymph node using one of the markers before neoadjuvant chemotherapy
• surgical treatment after neoadjuvant chemotherapy (targeted axillary dissection)

Exclusion Criteria

• refusal to participate in the study
• another treatment protocol, which does not include targeted axillary dissection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Iodine seed 125I marker	Targeted axillary dissection	Patients in whom the iodine seed 125I marker is used will be enrolled in this study arm and will undergo targeted axillary dissection.
Magnetic marker Magseed	Targeted axillary dissection	Patients in whom the magnetic marker Magseed is used will be enrolled in this study arm and will undergo targeted axillary dissection.
Carbon suspension	Targeted axillary dissection	Patients in whom the carbon suspension marker is used will be enrolled in this study arm and will undergo targeted axillary dissection.

Primary Outcome Measures

Name	Time	Method
Depth of marker implantation	During surgery/intervention	The depth of marker implantation will be assessed and measured in millimetres
Marker migration	During surgery/intervention	Marker migration will be assessed and measured in millimetres
Success-rate of resection of the marked lymph node	1 month	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	1 month	The time from localizing the pathological lymph node using the marker to surgery will be analysed and measured in days

Trial Locations

Locations (5)

Silesian Hospital in Opava; 🇨🇿 Opava, Moravian-Silesian Region, Czechia

University Hospital Ostrava; 🇨🇿 Ostrava, Moravian-Silesian Region, Czechia

EUC Clinic in Zlín; 🇨🇿 Zlín, Zlín Region, Czechia

Institute for the Care of Mother and Child, Prague, Czech Republic; 🇨🇿 Praha, Prague, Czechia

Masaryk Memorial Cancer Institute; 🇨🇿 Brno, South Moravian Region, Czechia