Clinical trial NCT05161507: Magseed and Magtrace Localization for Breast Cancer
Official title: Targeted Axillary Dissection, Sentinel Biopsy, and Tumor Lesion Localization in Breast Cancer Patients Using the New Magnetic "Sentimag" Detection System
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Carcinoma
Breast Carcinoma Metastatic in Lymph Node
Keywords: Breast cancer
Sentinel lymph node
Super paramagnetic iron oxide
Magseed
Magtrace
Sentimag
Lead sponsor: University Hospital Ostrava
Sponsor class: OTHER
First posted: 2021-12-17
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with breast carcinoma

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.

Detailed description: 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. It also aims to follow skin discoloration after Magtrace injection and describe when and how it resolves. The Magtrace will be injected preoperatively. Sentinel node biopsy will be performed and detection rates will be recorded for both methods.

The other part of the study will be the implantation of the smallest non-radioactive seed, Magseed, in the non-palpable breast cancer lesions. Intraoperative localization of the seed is achieved with the use of the Sentimag probe.

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. To accurately assess the response in the breast and the axilla, it is important that both the positive lymph node/s are marked before neoadjuvant systemic therapy to be able to locate them later on. Systemic therapy can negatively impact lymphatic drainage and hence reduce the accuracy of the sentinel lymph node biopsy (SLNB). However, when SLNB is paired with the removal of the previously positive target lymph node, a technique called Targeted Axillary Dissection, the operation becomes a lot more accurate, with lower morbidity of the patients.

A part of the study is also the verification of the time stability of breast tumor labeling with Magseed in the period from the onset of neoadjuvance to the subsequent operation following the oncological pretreatment of the patient.

All patients will undergo sentinel lymph node detection also by the classic detection system with Tc99.

Patients receive the Magseed marker via ultrasound-guided injection into a lymph node or to non-palpable breast cancer lesion.

After completion of the study, patients are followed up within 6-30 days post-surgery at our surgical clinic.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Accuracy of Magseed placement
timeFrame: During the surgical procedure
measure: Surgeon-rated ease of detected lymph node localization and removal
timeFrame: During the surgical procedure
measure: Number of nodes retrieved within the surgical specimen containing the Magseed
timeFrame: During the surgical procedure
measure: Surgeon-rated ease of detected labeled lesion localization and removal
timeFrame: During the surgical procedure
measure: Transcutaneous detection rate
timeFrame: During the surgical procedure
measure: Incidence of adverse events
timeFrame: Up to 6 weeks post-procedure
Secondary outcomes:
Other outcomes:
Locations:
city: Ostrava
country: Czechia
facility: University Hospital Ostrava
state: Moravian-Silesian Region
Study officials:
affiliation: University Hospital Ostrava
name: Daniel Toman, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University Hospital Ostrava
name: Otakar Kubala, MD,PhD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.
citation: 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.