Clinical trial · Interventional
Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening: A Multicenter, Parallel-group, Cluster Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ultrasound | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Screening of the subjects was conducted using an ultrasonic robot. | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention group: Using an ultrasound robot to screen the subjects
- interventionNames
- Device: Screening of the subjects was conducted using an ultrasonic robot.
- type
- NO_INTERVENTION
- label
- The subjects are scanned with traditional hand-held ultrasound.
- description
- The subjects are scanned with traditional hand-held ultrasound.The images are diagnosed by radiologists.
Primary outcomes (1)
- measure
- The detection rate of breast cancer
- timeFrame
- After participating in the screening, the subjects will be followed up for 24 months.
- description
- Number of detected ductal carcinoma in situ (DCIS) and invasive breast cancers divided by the total number of screened participants.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
- Maximum age
- 64 Years
Show eligibility criteria text
Inclusion Criteria: 1. women aged 35-64 years 2. no history of breast cancer 3. ownership and ability to use a smartphone 4. willingness to participate in the screening program. Exclusion Criteria: 1. Women who have undergone breast removal surgery; 2. Pregnant and lactating women; 3. Women who have undergone breast cancer screening within the past year;
References
Publications (0)
Data not yet available