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Magseed and Magtrace Localization for Breast Cancer

NCT05161507 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 70

Last updated 2024-01-26

No results posted yet for this study

Summary

The aim of this study is to compare the efficacy of the Sentimag localization system and its tracer Magtrace, superparamagnetic iron oxide nanoparticles, as a tracer in sentinel node biopsy in breast cancer with Tc99 in a single-center prospective study. The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Another part of the study will be the implantation of Magseed in the positive axillary lymph nodes in patients diagnosed with clinically positive lymph nodes that will receive neoadjuvant systemic therapy.

Conditions

  • Breast Carcinoma
  • Breast Carcinoma Metastatic in Lymph Node

Interventions

PROCEDURE

Magseed

Patients with the non-palpable histologically confirmed breast cancer lesion - the tumor lesion will be labeled with Magseed and patient will undergo breast-conserving surgery and sentinel lymph node detection with Tc99.

PROCEDURE

Magtrace

Patients with the palpable histologically confirmed breast cancer lesion - The Magtrace will be injected preoperatively into the tumor and detected by Sentimag. Patient will undergo sentinel lymph node detection with Tc99 and Sentimag localization system with breast surgery.

PROCEDURE

Axillary lymph node metastasis - needle biopsy

Patients with the histologically confirmed breast cancer lesion with Axillary lymph node metastasis with pathologic confirmation by needle biopsy - the positive axillary lymph node lesion will be labeled with Magseed before the neoadjuvant systemic therapy, and later during target axillary dissection will be performed the biopsy of labeled lymph node during breast surgery.

Sponsors & Collaborators

  • University Hospital Ostrava

    lead OTHER

Principal Investigators

  • Daniel Toman, MD · University Hospital Ostrava

  • Otakar Kubala, MD,PhD · University Hospital Ostrava

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-05-04
Primary Completion
2021-12-31
Completion
2023-12-31

Countries

  • Czechia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05161507 on ClinicalTrials.gov