Ideal Marker for Targeted Axillary Dissection (IMTAD)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: 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 Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Czechia
  • Moravian-Silesian Region
    • Opava, Moravian-Silesian Region, Czechia, 74601
      • Silesian Hospital in Opava
    • Ostrava, Moravian-Silesian Region, Czechia, 70852
      • University Hospital Ostrava
  • Prague
    • Praha, Prague, Czechia, 14700
      • Institute for the Care of Mother and Child, Prague, Czech Republic
  • South Moravian Region
    • Brno, South Moravian Region, Czechia, 65653
      • Masaryk Memorial Cancer Institute
  • Zlín Region
    • Zlín, Zlín Region, Czechia, 76001
      • EUC Clinic in Zlín

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with breast cancer confirmed with a biopsy, indicated for neoadjuvant chemotherapy and axillary dissection, in whom pathological lymph nodes have been marked using one of the three examined and compared markers.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Depth of marker implantation	The depth of marker implantation will be assessed and measured in millimetres	During surgery/intervention
Marker migration	Marker migration will be assessed and measured in millimetres	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.	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	1 month

Collaborators and Investigators

• Sponsor: University Hospital Ostrava
• Collaborators: University of Ostrava; Silesian Hospital in Opava; Masaryk Memorial Cancer Institute; EUC Clinic in Zlín; Institute for the Care of Mother and Child, Prague, Czech Republic
• Investigators: Principal Investigator: Jan Žatecký, MD, Silesian Hospital in Opava

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): May 30, 2023

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: October 1, 2020
• First Posted (Actual): October 8, 2020

Study Record Updates

• Last Update Posted (Actual): September 7, 2023
• Last Update Submitted That Met QC Criteria: September 6, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: breast cancer; axillary dissection; Magseed marker; iodine seed; carbon suspension; axillary lymph node
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: CHIR-05-IMTAD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data may be made available to other researchers upon request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No