Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

The research will study the qualitative analysis indicators of contrast-enhanced ultrasound, including: enhancement uniformity, enhanced range, presence or absence of enhancement defect area, presence or absence of nourishing blood vessels, etc.; and quantitative analysis indicators, including: peak time, peak intensity, rising slope, Area under the curve, etc., analyze the correlation between the changes of various parameters before and after neoadjuvant treatment（NAT） and the pathological response of patients, and try to find indicators and cut-off values that can predict and early evaluate the efficacy.

This study will study the qualitative and quantitative parameters of MRI-enhanced scanning and the changes of DWI parameters, analyze the correlation between the parameters of patients before and after NAT and pathological response, and try to find indicators and cut-off values that can predict and early evaluate the efficacy.

Contrast-Enhanced Ultrasound

Jun Luo, Master

Jie Chen, Master

In view of the lack of systematic curative effect prediction and early evaluation indicators for breast cancer neoadjuvant chemotherapy, the effective fusion of CEUS（contrast-enhanced ultrasound） and MRI is realized, and a multi-modal standardized evaluation system of NAT based on the dynamics across time and full cycle is constructed, in order to find the predictive effect and early evaluation of NAT. Means to improve the accuracy of NAT patient selection, treatment course selection, and efficacy evaluation, to achieve controllable and individualized and precise NAT, thereby improving efficacy, reducing unnecessary treatment adverse reactions, guiding pathological materials, reducing medical costs, and ultimately improving breast cancer The patient's DFS and OS. In addition, for patients with axillary lymph node cN0 before and after neoadjuvant or descending after neoadjuvant, the evaluation system is used to explore the feasibility, safety, and effectiveness of replacing sentinel lymph node biopsy or carrying out sentinel lymph node biopsy, which is a useful strategy for axillary lymph node management in such patients. Develop a theoretical foundation.

Multimodal Imaging Evaluation System of Axillary Lymph Node Staging and Treatment Strategy for Breast Cancer Neoadjuvant Therapy

By studying the qualitative analysis indicators of contrast-enhanced ultrasound, including: enhancement uniformity, enhanced range, presence or absence of enhancement defect area, presence or absence of nourishing vessels, etc.; and quantitative analysis indicators, including: peak time, peak intensity, rising slope, under the curve Area, etc., analyze the correlation between the changes of the parameters before and after NAT and the pathological response.

By studying the qualitative and quantitative parameters of MRI-enhanced scanning and the changes of DWI parameters, the correlation between the parameters before and after NAT and the pathological response of patients is analyzed.

Combining the high sensitivity of ultrasound in the recognition of superficial lymph nodes, the feasibility of contrast-enhanced ultrasound in the identification, location and diagnosis of sentinel lymph nodes in breast cancer, and the integrity of MRI, to discuss the formulation of multi-imaging systems for the treatment of axillary lymph nodes in patients with lymph node degeneration after NAT The feasibility, safety and effectiveness of clinical application.

Based on the above three research results, a mathematical model is established, a multi-modal and multi-parameter evaluation system combining multiple images is constructed, and the strengths are complemented to establish an economic and efficient evaluation index system and standardized process.

Sichuan Provincial People's Hospital

Principal researchers

Symptoms and General Pathology

Neoplasm Metastasis

Magseed marker deployed percutaneously, prior to patient undergoing neo-adjuvant chemotherapy (NAC), under ultrasound guidance to mark a lymph node intended for selective surgical removal post NAC.

Implantable Magseed marker for marking lesions in soft tissue, detected using the Sentimag handheld probe.

Magseed Marker

Matt Womack, PhD

Ivan Marin

Veronika Noregil

Kelly Hunt, MD, F.A.C.S.

Abigail Caudle, MD, MS

The purpose of this study is to provide prospective evidence that the use of Magseed/Sentimag in marking axillary lymph nodes and guiding surgical localization in patients with breast cancer following neo-adjuvant chemotherapy (NAC) is effective.

This is a post-market, prospective, open-label, single arm study of Magseed and Sentimag in patients with breast cancer with biopsy-proven axillary node metastases who had a clip placed to mark the metastatic node and are having that clipped node selectively removed at surgery following neo-adjuvant chemotherapy (NAC). Subjects will have the Magseed placed to mark axillary lymph nodes with biopsy-proven metastasis under ultrasound guidance before initiating NAC. After completion of NAC, the Magseed will be localized using the Sentimag system during surgery and removed with the targeted lymph node.

Magseed Enabled Long-Term Localization of Axillary Lymph Nodes

A Prospective Open Label Study of the Use of Magseed® Markers and Sentimag® to Localize Axillary Lymph Nodes With Biopsy-proven Metastases in Breast Cancer Patients

The retrieval rate of the clipped node and Magseed in the excised specimen. This is defined as the number of subjects in whom the clipped node and Magseed are retrieved in a single excised specimen divided by the total number of subjects.

Rates of device-related adverse events and serious device-related adverse events

5 point Likert scale, very easy = 5, very difficult = 1

Success rate of seed placement (placement accuracy)

Success rate of maintained seed position at the completion of NAC

Number of nodes retrieved within the surgical specimen containing the Magseed

5 point Likert scalevery easy = 5, very difficult = 1

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multimodal Imaging Evaluation System of Axillary Lymph Node Staging and Treatment Strategy for Breast Cancer Neoadjuvant Therapy	NCT04661436	Breast Cancer	Contrast-Enhanc...	18 Years - 70 Years	Sichuan Provincial People's Hospital
Magseed Enabled Long-Term Localization of Axillary Lymph Nodes	NCT03796559	Breast Cancer Axillary Lymph ...	Magseed Marker	18 Years -	Endomagnetics Ltd.
Multimodal Imaging Evaluation System of Axillary Lymph Node Staging and Treatment Strategy for Breast Cancer Neoadjuvant Therapy	NCT04661436	Breast Cancer	Contrast-Enhanc...	18 Years - 70 Years	Sichuan Provincial People's Hospital

Spots Global Cancer Trial Database for axillary lymph nodes