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Iron

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.

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.

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.

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.

Magseed

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.

Magtrace

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 - needle biopsy

Daniel Toman, MD

Otakar Kubala, MD,PhD

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.

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.

Magseed and Magtrace Localization for Breast Cancer

Targeted Axillary Dissection, Sentinel Biopsy, and Tumor Lesion Localization in Breast Cancer Patients Using the New Magnetic "Sentimag" Detection System

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

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.

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

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

Descriptive statistics will be used to summarize transcutaneous detection rate.

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.

University Hospital Ostrava

All prospective patients will receive a MagSeed in the diagnosed breast cancer tumor. In addition, they will receive MagTrace to detect the sentinel lymph node during surgery. Since this is an experimental study, the patients will also be injected with the golden standard of Technetium tracer.

Combining MagSeed and Magtracer to perform a wide local excision breast conserving surgery and sentinel node biopsy.

MagSeed and MagTrace in breast cancer patiënts

Rationale:

In breast cancer, a sentinel node procedure is performed to investigate whether malignant cells have spread to the axillary lymph nodes. This is an important part of determining the stage of breast cancer and the final treatment plan.

A disadvantage of the sentinel node procedure is that it is performed using radioactive tracing with concomitant radiation exposure for the patients and involved health care personnel. In addition, the use of radioactive tracing puts high demands on the logistics in the operation theatre: the capacity of patients that can be treated in one day is limited and the radio-active tracing leads to many time-consuming precautionary measures.

A radiation free alternative would therefore have multiple advantages. Not only with respect to radiation exposure for the patients and health care workers, but also by reducing the waiting time for operation for the patients as it will make the planning of patients for surgery more efficient.

Recently, a radiation free tracer for the sentinel node procedure has become available (Magtrace). This tracer has been tested in small-case studies and is currently used as standard care in several hospitals around the world.

Objective:

The primary objective of this study is to evaluate the diagnostic accuracy of Magtrace in the sentinel node procedure in breast cancer in the Breast Care Centre in Zuyderland Medical Centre; with the ultimate goal to make the sentinel node procedure a radiation free process.

Study design:

A prospective cohort of forty patients with breast cancer and an indication for a sentinel node procedure will be injected with both Technetium (radioisotope) and Magtrace (magnetic). All patients in this study will receive both tracers.

Study population:

Patients of 18 years or older with breast cancer and an indication for a sentinel node procedure will be included. These patients will be recruited by their breast surgeon in the outpatient department of the Breast Care Centre in Zuyderland Medical Centre.

Intervention (if applicable):

Sentinel node procedure using a magnetic tracer next to Technetium.

Main study parameters/endpoints:

The concordance in detection of sentinel nodes by Magtrace and the Technetium tracer, measured by the sensitivity and specificity of Magtrace in detecting sentinel nodes with Technetium tracer as gold standard.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness:

The goal of this project is evaluating the diagnostic accuracy of Magtrace in the sentinel node procedure. To establish that Magtrace is a non-inferior and a non-radioactive alternative for Technetium with respect to reliability in detecting metastases. The ultimate goal is to make the sentinel node procedure a radiation free process.

Magnetic Tracer in the Sentinel Node Procedure in Breast Cancer: the Non-radioactive Alternative for Radio-isotopes

Number of sentinel lymph nodes detected using MagTrace and Technetium and their concordance.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Magseed and Magtrace Localization for Breast Cancer	NCT05161507	Breast Carcinom... Breast Carcinom...	Magseed Magtrace Axillary lymph ...	18 Years -	University Hospital Ostrava
Magnetic Tracer in the Sentinel Node Procedure in Breast Cancer: the Non-radioactive Alternative for Radio-isotopes	NCT05122585	Breast Cancer	MagSeed and Mag...	18 Years -	Zuyderland Medisch Centrum

Spots Global Cancer Trial Database for magseed

Every month we try and update this database with for magseed cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for magseed

Every month we try and update this database with for magseed cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for magseed cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.