Magseed and Magtrace Localization for Breast Cancer

University Hospital Ostrava

Status: Completed

Conditions: Breast Carcinoma Metastatic in Lymph Node; Breast Carcinoma

Treatments: Procedure: Axillary lymph node metastasis - needle biopsy; Procedure: Magseed; Procedure: Magtrace

Study type: Observational

Funder types: Other

Identifiers

NCT05161507

05/RVO-FNOs/2020 (Other Grant/Funding Number)

CHIR-07-Sentimag

Details and patient eligibility

About

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.

Full 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.

Enrollment: 70 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

70 participants in 3 patient groups

Non-palpable breast cancer lesion

Description:

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.

Treatment:

Procedure: Magseed

Palpable breast cancer lesion

Description:

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.

Treatment:

Procedure: Magtrace

Axillary lymph node metastasis

Description:

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.

Treatment:

Procedure: Axillary lymph node metastasis - needle biopsy