Magseed and Magtrace Localization for Breast Cancer

NCT05161507 | Completed

• 2 other identifiers: CHIR-07-Sentimag05/RVO-FNOs/2020
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Breast cancer; Sentinel lymph node; Super paramagnetic iron oxide; Magseed; Magtrace; Sentimag

Outcome Measures

Primary Outcomes (6)

• Accuracy of Magseed placement

  Accuracy of Magseed placement will be measured regarding its position towards the lymph node in mm. Will be defined as accurate, marginal or inadequate. Descriptive statistics will be used to summarize accuracy of placement. Other statistical methods, when appropriate, may be used for analysis.

  During the surgical procedure

• Surgeon-rated ease of detected lymph node localization and removal

  Descriptive statistics will be used to summarize surgeon rated ease of localization.

  During the surgical procedure

• Number of nodes retrieved within the surgical specimen containing the Magseed

  Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed.

  During the surgical procedure

• Surgeon-rated ease of detected labeled lesion localization and removal

  Descriptive statistics will be used to summarize number of nodes retrieved within the surgical specimen containing the Magseed.

  During the surgical procedure

• Transcutaneous detection rate

  Descriptive statistics will be used to summarize transcutaneous detection rate.

  During the surgical procedure

• Incidence of adverse events

  Toxicity data will be summarized by frequency tables. For the toxicity endpoint, per-treated analysis will be used to include any patient who received the treatment regardless of the eligibility nor the duration or dose of the treatment received.

  Up to 6 weeks post-procedure

Study Arms (3)

Non-palpable breast cancer lesion

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

Procedure: Magseed

Palpable breast cancer lesion

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

Procedure: Magtrace

Axillary lymph node metastasis

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.

Procedure: Axillary lymph node metastasis - needle biopsy

Interventions

Magseed PROCEDURE

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.

Non-palpable breast cancer lesion

Magtrace PROCEDURE

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.

Palpable breast cancer lesion

Axillary lymph node metastasis - needle biopsy PROCEDURE

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.

Axillary lymph node metastasis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with breast carcinoma

You may qualify if:

• Histologically confirmed cT0-4 breast cancer
• Without/ With axillary lymph node metastasis with pathologic confirmation by needle biopsy
• With/ without received neoadjuvant chemotherapy prior to surgical resection

You may not qualify if:

• Distant metastases
• The subject is known to be pregnant
• Pacemaker of another implantable device in the chest wall
• Allergy to dextran or other iron-containing particles

Sponsors & Collaborators

• University Hospital Ostrava: lead

Study Sites (1)

University Hospital Ostrava

Ostrava, Moravian-Silesian Region, 70852, Czechia

Location

Related Publications (3)

• Rubio IT, Diaz-Botero S, Esgueva A, Rodriguez R, Cortadellas T, Cordoba O, Espinosa-Bravo M. The superparamagnetic iron oxide is equivalent to the Tc99 radiotracer method for identifying the sentinel lymph node in breast cancer. Eur J Surg Oncol. 2015 Jan;41(1):46-51. doi: 10.1016/j.ejso.2014.11.006. Epub 2014 Nov 15.

  PMID: 25466980 BACKGROUND

• Greenwood HI, Wong JM, Mukhtar RA, Alvarado MD, Price ER. Feasibility of Magnetic Seeds for Preoperative Localization of Axillary Lymph Nodes in Breast Cancer Treatment. AJR Am J Roentgenol. 2019 Oct;213(4):953-957. doi: 10.2214/AJR.19.21378. Epub 2019 Jun 5.

  PMID: 31166765 BACKGROUND

• Zacharioudakis K, Down S, Bholah Z, Lee S, Khan T, Maxwell AJ, Howe M, Harvey J. Is the future magnetic? Magseed localisation for non palpable breast cancer. A multi-centre non randomised control study. Eur J Surg Oncol. 2019 Nov;45(11):2016-2021. doi: 10.1016/j.ejso.2019.06.035. Epub 2019 Jun 26.

  PMID: 31288944 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Sentinel lymph node extirpation

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Toman, MD

  University Hospital Ostrava

  PRINCIPAL INVESTIGATOR

• Otakar Kubala, MD,PhD

  University Hospital Ostrava

  STUDY CHAIR

Study Design

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

Study Record Dates

• First Submitted: September 23, 2020
• First Posted: December 17, 2021
• Study Start: May 4, 2020
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2023
• Last Updated: January 26, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)