Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Neoplasm Metastasis

Breast Neoplasms

Lymphatic Metastasis

Neoplastic Processes

Breast Diseases

Skin Diseases

Eligible patients undergo lymph node biopsy or lymph node dissection. Before surgery, the status of axillary lymph node status was evaluated using ultrasound. After surgery, all lymph node specimens would be collected and be assessed using ultrasound in a special evaluation system in vitro.

High-frequency ultrasound is used to detected the lymph node metastasis in vivo and vitro. The lymph node number, morphology and elastographic parameters are collected in the patients and in fresh lymph node specimens.

Ultrasound evaluation

Shu Wang, MD

The status of axillary lymph node (ALN) is an important reference indicator for breast cancer surgery and systemic treatment, which is also an important prognostic indicator for breast cancer. Therefore, it is extremely important for surgeons to accurately determine whether axillary lymph nodes have metastasis and the number of metastatic lymph nodes. The value of ultrasound diagnosing the status of axillary lymph nodes was controversial in recent publications. Therefore, there is a high need to prove the accuracy and precision of ultrasound for axillary lymph node metastasis in breast cancer patients. The aim of this study is to assess the usefulness of ultrasound in the diagnosis of axillary lymph node status in breast cancer patients by gathering in vivo and vitro ultrasonographic parameters to build a clinical useful categorization system

To facilitate the non-invasive assessment of lymph node status preoperatively, we use ultrasound to detect lymph node metastasis. We designed this study to obtain in vivo and vitro ultrasound features and parameters. Before surgery, the detailed ultrasound features are collected during routine ultrasound examination. After the completion of the axillary surgery, fresh lymph node specimens are collected for in vitro ultrasound evaluation one by one in a specially-designed detection system. Statistical models are built to categorize the probability of metastasis of lymph node according to a proposed categorization system similar as BI-RADS(Breast Imaging Reporting and Data System), which is named NI-RADS (Node Imaging Reporting and Data System).

Fresh lymph node specimens from breast cancer patients were detected using ultrasound.

The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis: a Proposal of NI-RADS

The Accuracy of High-resolution Ultrasound in the Detection of Lymph Node Metastasis From Breast Cancer and the Proposal of Node Imaging Reporting and Data System

True positive rate measures the proportion of positives that are correctly identified by ultrasound

The true negative rate measures the proportion of negatives that are correctly identified.

A diagnostic model or nomogram would be developed to facilitate the diagnosis of the lymph node ultrasound.

Peking University People's Hospital

Clinical Professor

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Eligible patients undergo lymph node biopsy with FNA and crpo-assisted stick freeze device sequentially.

Patients undergo lymph node biopsy with FNA alone.

Rotational core needle biopsy would be done under local anesthesia. A small incision would be made in the axilla and core needle biopsy be performed using a special cryo-assisted stick freeze device (Cassi II, Scion Medical Technologies, USA). The cytological and histological specimens would be sent for diagnosis.

Cryo-assisted core needle biopsy

FNA would be performed using a 10ml syringe with a 24 gauge needle without anesthesia.

Axillary lymph node status is a vital prognostic factor in breast cancer patients and provides crucial information for making treatment decisions. Ultrasound test with subsequent fine needle aspiration (FNA) biopsy in nodes with suspicious features remains the standard of axillary lymph node workup. Insufficient sampling and limited diagnostic accuracy of cytological test compromise the outcome the preoperative lymph node staging strategy especially in patients with intermediate suspicious nodes. This prospective study is to compare the performance of a crpo-assisted core biopsy with FNA.

This prospective study was planned to evaluate the superiority of a core needle biopsy device with a special cryo-assisted rotational design (Cassi II, USA) compared with FNA for biopsy of intermediately suspicious lymph nodes. Eligible patients would be randomized to one of two arms by 1:2 : Core with FNA or FNA alone. The diagnostic accuracy and adverse outcome of core and FNA would be compared.

Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes

Comparison of the Accuracy and Safety of Biopsy in Suspicious Axillary Lymph Nodes With a Crypo-assisted Stick Freeze Biopsy Device or Fine Needle Aspiration

True positive rate measures the proportion of positives that are correctly identified by Core needle or FNA

The specimen amount or quality for diagnosis is adequate or not evaluated by pathologists

Hematoma, bleeding need , suture exposure and extrusion.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis: a Proposal of NI-RADS	NCT03791840	Breast Neoplasm...	Ultrasound eval...	18 Years - 90 Years	Peking University People's Hospital
The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis: a Proposal of NI-RADS	NCT03791840	Breast Neoplasm...	Ultrasound eval...	18 Years - 90 Years	Peking University People's Hospital
Comparison of Two Types of Biopsy in Suspicious Axillary Lymph Nodes	NCT03130946	Breast Neoplasm...	Cryo-assisted c... FNA	18 Years - 70 Years	Peking University People's Hospital

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