Ignite Creation Date:
2024-05-06 @ 12:34 PM
Last Modification Date:
2024-10-26 @ 1:00 PM
Study NCT ID:
NCT03791840
Status:
COMPLETED
Last Update Posted:
2022-10-18
First Post:
2018-12-31
Brief Title:
The Value of High-resolution Ultrasound in the Detection of Lymph Node Metastasis a Proposal of NI-RADS
Sponsor:
Peking University Peoples Hospital
Organization:
Peking University Peoples Hospital
Study Overview
Official Title:
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
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NI-RADS
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
Detailed Description:
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-RADSBreast Imaging Reporting and Data System which is named NI-RADS Node Imaging Reporting and Data System
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None