Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Breast Diseases

Skin Diseases

pateint with postive node undergo further staging

Mennatallahh A Taha, assistant lecturer

Amira H Radwan, lecturer

Mennatallahh Taha

amira h radwan

The regional lymph node status is considered to be an important prognostic factor regarding the long-term survival of breast cancer (BC) patients (Cetin IA, et al . 2020). The knowledge of whether lymph nodes are tumor-infiltrated or not is essential since nodal involvement has decisive therapeutic consequences such as axillary lymph node dissection (ALND), axillary radiotherapy, and neoadjuvant or adjuvant systemic chemotherapy (Diessner J et al . 2023). To provide individualized therapeutic options and optimized therapy.

The following data will be collected from electronic or paper medical data records as:

1) Age 2 )Sex 3)Family history of breast cancer 4)Menopausal status 5 )Body mass index (BMI) 6) Histological type of BC as reported in pathology 7) The results of the lymph node status. 8)Registered data will be collected from the hospital databases and clinical sheers. 3 9) The gold standard reference in the evaluation of suspicious lymph nodes by nodal biopsy and postoperative pathology. Imaging technique and interpretation The imaging diagnostic for BC (MRI, CT, mammography, and ultrasound) patients are carried out by the Department of Diagnostic and Interventional Radiology of the Hospitals in the research and interpreted by radiologists at the time of BC diagnosis. The radiological reports for each patient and each imaging technique will be analyzed about the lymph node status. The nodal status will be reported as benign, indeterminate, and infiltrated as stated by the ACR lexicon. Mammography and US For mammography, we will use full-field digital mammography systems with the option of additional tomosynthesis for further characterization of the primary tumor at NCI with the commercially available The BC patients routinely receive an ultrasound exam including the evaluation of the breast and the axilla with the lymphatic drainage pathways as a part of the follow-up process active lymph nodes. p values lower than 0.05 will be considered significant.

Evaluation of Different Imaging Modalities in Regional Lymph Nodes Staging in Patients With Breast Cancer

Evaluation of Different Imaging Modalities in Regional Nodes Staging in Breast Cancer Patient

Mennatallah Arous Mohamed

assistant lecteurer

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Micronutrients

All Drugs and Chemicals

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluation of Different Imaging Modalities in Regional Lymph Nodes Staging in Patients With Breast Cancer	NCT06185946	Breast Carcinom...		25 Years - 65 Years	Sohag University
Evaluation of Different Imaging Modalities in Regional Lymph Nodes Staging in Patients With Breast Cancer	NCT06185946	Breast Carcinom...		25 Years - 65 Years	Sohag University
Magseed and Magtrace Localization for Breast Cancer	NCT05161507	Breast Carcinom... Breast Carcinom...	Magseed Magtrace Axillary lymph ...	18 Years -	University Hospital Ostrava
Evaluation of Different Imaging Modalities in Regional Lymph Nodes Staging in Patients With Breast Cancer	NCT06185946	Breast Carcinom...		25 Years - 65 Years	Sohag University

Spots Global Cancer Trial Database for breast carcinoma metastatic in lymph node