NCT04580251

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2021

Typical duration for all trials

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 1, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2023

Completed
Last Updated

September 7, 2023

Status Verified

September 1, 2023

Enrollment Period

2 years

First QC Date

October 1, 2020

Last Update Submit

September 6, 2023

Conditions

Breast Cancer

Keywords

breast canceraxillary dissectionMagseed markeriodine seedcarbon suspensionaxillary lymph node

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (3)

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

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

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

Interventions

Targeted axillary dissectionPROCEDURE

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 suspensionIodine seed 125I markerMagnetic marker Magseed

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Silesian Hospital in Opava

Opava, Moravian-Silesian Region, 74601, Czechia

Location

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Institute for the Care of Mother and Child, Prague, Czech Republic

Prague, Prague, 14700, Czechia

Location

Masaryk Memorial Cancer Institute

Brno, South Moravian, 65653, Czechia

Location

EUC Clinic in Zlín

Zlín, Zlín, 76001, Czechia

Location

Related Publications (1)

  • Zatecky J, Coufal O, Zapletal O, Kubala O, Kepicova M, Faridova A, Raus K, Gatek J, Kosac P, Peteja M. Ideal marker for targeted axillary dissection (IMTAD): a prospective multicentre trial. World J Surg Oncol. 2023 Aug 19;21(1):252. doi: 10.1186/s12957-023-03147-x.

    PMID: 37596658DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jan Žatecký, MD

    Silesian Hospital in Opava

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2020

First Posted

October 8, 2020

Study Start

January 1, 2021

Primary Completion

January 1, 2023

Study Completion

May 30, 2023

Last Updated

September 7, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Individual participant data may be made available to other researchers upon request.

Locations

CZ(5)