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

NCT03791840 | Completed

• 1 other identifier: PKUPHUS002
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Breast Neoplasms

Keywords

breast neoplasms; Ultrasonography, Interventional; Biopsy, Large-Core Needle; Biopsy, Fine-Needle

Outcome Measures

Primary Outcomes (1)

• Sensitivity of ultrasound

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

  Through study completion, an average of 1 year.

Secondary Outcomes (2)

• Specificity of ultrasound

  Through study completion, an average of 1 year.

• Diagnostic model of lymph node ultrasound

  Through study completion, an average of 1 year

Study Arms (1)

Ultrasound evaluation

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.

Diagnostic Test: Ultrasound evaluation

Interventions

Ultrasound evaluation DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with invasive breast cancer planned to receive surgical axillary lymph node staging are eligible.

You may qualify if:

• Histologically confirmed invasive breast cancer.
• Pathological axillary lymph node staging planned.
• Axillary lymph node not removed prior to the study.

You may not qualify if:

• Refusal participation in the study.

Sponsors & Collaborators

• Peking University People's Hospital: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 10044, China

Location

Related Publications (1)

• Han P, Yang H, Liu M, Cheng L, Wang S, Tong F, Liu P, Zhou B, Cao Y, Liu H, Wang C, Peng Y, Shen D, Wang S. Lymph Node Predictive Model with in Vitro Ultrasound Features for Breast Cancer Lymph Node Metastasis. Ultrasound Med Biol. 2020 Jun;46(6):1395-1402. doi: 10.1016/j.ultrasmedbio.2020.01.030. Epub 2020 Mar 5.

  PMID: 32146007 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

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

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Shu Wang, MD

  Peking University People's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 31, 2018
• First Posted: January 3, 2019
• Study Start: December 1, 2017
• Primary Completion: January 1, 2019
• Study Completion: July 1, 2022
• Last Updated: October 18, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)