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Recruiting NCT07331363

Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening: A Multicenter, Parallel-group, Cluster Randomized Controlled Trial

No phase Interventional Breast Cancer Ultrasound

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Screening of the subjects was conducted using an ultrasonic robot..
Who it may be relevant to
Registry conditions: Breast Cancer, Ultrasound. Basic parameters: 35 years — 64 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Overview

The goal of this clinical trial is to learn if robotic ultrasound screening works as well as or better than traditional sonographer-led screening for detecting breast cancer. It will also explore how well participants follow recommended post-screening care. The main questions it aims to answer are: Does robotic ultrasound screening detect more cases of breast cancer compared to traditional sonographer-led screening? How well do participants follow up on recommended care after robotic ultrasound screening? Researchers will compare robotic ultrasound screening to traditional sonographer-led screening to see if robotic ultrasound works effectively for breast cancer screening. Participants will: Receive a breast ultrasound performed either by a robotic system or a human sonographer. Undergo follow-up management based on their BI-RADS classification.

Interventions

  • Device Screening of the subjects was conducted using an ultrasonic robot.
    The ultrasound robot automatically scans the breasts of subjects via its mechanical arm and generates images.The diagnosis is made based on the radiologist's interpretation of the images.

Primary outcome measures

  • The detection rate of breast cancer [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
Secondary outcome measures (12)
  • Cancer type [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
  • The early diagnosis rate [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
  • Lymph node status [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
  • Breast cancer clinical stage [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
  • Histological Grading of Breast Cancer [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
  • Breast cancer screen recall rate [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
  • The positive predictive value [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
  • The breast cancer biopsy rate [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
  • Referral adherence rate [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
  • Interval cancer incidence [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
  • Breast cancer mortality [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]
  • All-cause mortality [Time frame: After participating in the screening, the subjects will be followed up for 24 months.]

Eligibility criteria

Inclusion criteria

  • women aged 35-64 years
  • no history of breast cancer
  • ownership and ability to use a smartphone
  • willingness to participate in the screening program.

Exclusion criteria

  • Women who have undergone breast removal surgery;
  • Pregnant and lactating women;
  • Women who have undergone breast cancer screening within the past year;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Screening

Study locations

China · 1 center
  • Rural health centers and community health centers — Xiantao

Identifiers

NCT: NCT07331363 · HuazhongU20251203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗