NCT05443672

Brief Summary

This multi-center study intends to evaluate the value of the detection and differential diagnosis of breast mass using deep learning AI-based real-time ultrasound examination.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,122

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2021

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 12, 2021

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 29, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 5, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2023

Completed
Last Updated

July 5, 2022

Status Verified

June 1, 2022

Enrollment Period

1.1 years

First QC Date

June 29, 2022

Last Update Submit

June 29, 2022

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

  • Diagnostic performance of breast mass using deep learning AI-based real-time ultrasound examination

    Pathology as a gold standard, to evaluate the diagnostic performance (sensitivity, specificity and accuracy)

    12 months

Interventions

Yizhun BUSMSDEVICE

During the breast scanning, Yizhun BUSMS uses different color box to identify the breast lesion, and the box color indicates the risk grade of the lesion.

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Femal patients with breast neoplasm

You may qualify if:

  • Females who undergo ultrasound examination for a complaint of breast lesion;
  • The breast lesion that will obtain definite pathological diagnosis or follow-up at least two years.

You may not qualify if:

  • The breast lesion that has received CNB or FNA;
  • The breast cancer patient who has received neoadjuvant chemotherapy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Yong Wang

    Cancer Institute and Hospital, Chinese Academy of Medical Sciences

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Wang

CONTACT

13391817899drwangyong77@163.com

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2022

First Posted

July 5, 2022

Study Start

August 12, 2021

Primary Completion

August 31, 2022

Study Completion

August 31, 2023

Last Updated

July 5, 2022

Record last verified: 2022-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)