Skip to main content
OpenTrials
Completed

NCT Number: NCT04580251

Ideal Marker for Targeted Axillary Dissection

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Silesian Hospital in Opava, Opava, Moravian-Silesian Region, Czechia

Loading trial locations.

About this study

There are two basic aims of the study

  • Prospective comparison of the reliability and accuracy of individual markers used for marking of a pathological axillary lymph node with subsequent targeted axillary dissection.
  • 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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Targeted Axillary Dissection

Procedure

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)

Primary outcomes

  1. Depth of marker implantation

    Time frame: During surgery/intervention

    The depth of marker implantation will be assessed and measured in millimetres

  2. Marker migration

    Time frame: During surgery/intervention

    Marker migration will be assessed and measured in millimetres

  3. Success-rate of resection of the marked lymph node

    Time frame: 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.

  4. Time from localizing the pathological lymph node using the marker to surgery

    Time frame: 1 month

    The time from localizing the pathological lymph node using the marker to surgery will be analysed and measured in days

Sponsors and collaborators

Lead sponsor

University Hospital Ostrava

Other

Collaborators

  • EUC Clinic in Zlín
  • Institute for the Care of Mother and Child, Prague, Czech Republic
  • Masaryk Memorial Cancer Institute
  • Silesian Hospital in Opava
  • University of Ostrava

Registry information

Acronym: IMTAD

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 8, 2020
Registry last updated
Sep 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.