Breast CancerNCT07331363
Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening
A study testing Screening of the subjects was conducted using an ultrasonic robot. in people with Breast Cancer and Ultrasound, run by Huazhong University of Science and Technology at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 64 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Ultrasound
- What is being tested?
- Screening of the subjects was conducted using an ultrasonic robot.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70,000 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2025to 10 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 64 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- women aged 35-64 years
- no history of breast cancer
- ownership and ability to use a smartphone
- willingness to participate in the screening program.
Who cannot join
- Women who have undergone breast removal surgery;
- Pregnant and lactating women;
- Women who have undergone breast cancer screening within the past year;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Rural health centers and community health centers
Xiantao, Hubei, 433000
Xiaoxv Yin, Doctor, 86+13871187781, yxx@hust.edu.cn
yxx@hust.edu.cn
About this study
Official title: Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening: A Multicenter, Parallel-group, Cluster Randomized Controlled Trial
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.
Read more
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
- Breast Cancer, Ultrasound
- Being tested
- Screening of the subjects was conducted using an ultrasonic robot.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Screening of the subjects was conducted using an ultrasonic robot.Device
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.
| Study group | Role | What they receive |
|---|---|---|
| ultrasound robot | Experimental | Not described Receives: Device: Screening of the subjects was conducted using an ultrasonic robot. |
| traditional hand-held ultrasound | No intervention | The subjects are scanned with traditional hand-held ultrasound.The images are diagnosed by radiologists. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The detection rate of breast cancer
Number of detected ductal carcinoma in situ (DCIS) and invasive breast cancers divided by the total number of screened participants.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
Secondary outcomes (13)
Cancer type
Non-invasive cancer (DCIS), early invasive cancer, and invasive cancer.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
The early diagnosis rate
The early diagnosis rate is defined as the number of breast cancer cases with TNM stage 0, I, or IIa divided by the number of women diagnosed with breast cancer or other malignant breast tumors during screening*100.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
Lymph node status
Presence of lymph node metastasis; size, morphology, internal structure, margin characteristics, and vascularity of metastatic lymph nodes.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
Breast cancer clinical stage
TNM staging, representing tumor size (T), lymph node involvement (N), and distant metastasis (M).
Measured: After participating in the screening, the subjects will be followed up for 24 months.
Histological Grading of Breast Cancer
The internationally accepted Nottingham Histological Grading System is used. This system provides a semi-quantitative and objective assessment of invasive breast cancer. It evaluates three parameters: the proportion of tubule formation, nuclear pleomorphism, and mitotic count. The scores of the three parameters are added together. A total score of 3-5 indicates Grade 1 (G1, well-differentiated/low grade). A total score of 6-7 indicates Grade 2 (G2, moderately differentiated/intermediate grade). A total score of 8-9 indicates Grade 3 (G3, poorly differentiated/high grade).
Measured: After participating in the screening, the subjects will be followed up for 24 months.
Breast cancer screen recall rate
Breast cancer screen recall is defined as further assessment triggered by abnormal ultrasound findings (BI-RADS 0 or 3 and above). The recall rate is the number of women actually recalled divided by the number of women screened.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
The positive predictive value
The positive predictive value of recall is the percentage of recalled women who are diagnosed with breast cancer.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
The breast cancer biopsy rate
The breast cancer biopsy rate is defined as the number of women who actually underwent biopsy divided by the number of women screened. The positive predictive value of biopsy is defined as the percentage of women diagnosed with breast cancer among those who received a biopsy.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
Referral adherence rate
Defined as the average adherence to recommended referral for confirmed diagnosis (biopsy and histopathology). It is calculated as the number of women actually referred divided by the number of women recommended for referral.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
Interval cancer incidence
Defined as the proportion of women who had a negative or false-positive screening (i.e., no ductal carcinoma in situ or invasive breast cancer) and were subsequently diagnosed with invasive breast cancer within a certain period after screening. Following the national breast cancer screening guideline recommending screening every 2-3 years, this study will evaluate the interval cancer incidence at 24 months, i.e., the proportion of women diagnosed with breast cancer 24 months after a negative screen or 6-24 months after a false-positive screen.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
Breast cancer mortality
Defined as the number of deaths due to breast cancer within 24 months after screening divided by the total number of women screened.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
All-cause mortality
Defined as the total number of deaths from any cause within 24 months after screening divided by the total number of women screened.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
Post-screening management adherence
Defined as the proportion of women who completed the recommended follow-up medical actions after screening (referral, re-examination, additional tests, etc.). The adherence rate is calculated as the number of participants who completed the recommended management within the specified time / the number of participants requiring further management * 100%.
Measured: After participating in the screening, the subjects will be followed up for 24 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2026
- Study start10 Dec 2025
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Huazhong University of Science and TechnologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huazhong University of Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaoxv Yin, PhD, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07331363
- Sponsor's protocol ID
- HuazhongU20251203
- Status last verified
- Oct 2026
- First submitted
- 28 Dec 2025
- Last updated
- 29 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Using Ultrasound Robots for Breast Cancer Screening: A Multicenter, Parallel-group, Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07331363
- Acronym / sponsor ID
- HuazhongU20251203
- Conditions
- Breast Cancer, Ultrasound
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70,000 participants (estimated)
- Lead sponsor
- Huazhong University of Science and TechnologyUniversity, hospital or other
- Study start
- 10 Dec 2025 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Dec 2026 (estimated)
- First posted
- 9 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound robot | Experimental | Device: Screening of the subjects was conducted using an ultrasonic robot. |
| traditional hand-held ultrasound | No intervention | –The subjects are scanned with traditional hand-held ultrasound.The images are diagnosed by radiologists. |
Who may qualify
- Ages
- 35 to 64 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- women aged 35-64 years
- no history of breast cancer
- ownership and ability to use a smartphone
- willingness to participate in the screening program.
Key exclusion criteria (3 listed)
- Women who have undergone breast removal surgery;
- Pregnant and lactating women;
- Women who have undergone breast cancer screening within the past year;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | ultrasound robot |
Primary outcome
The detection rate of breast cancer
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
Number of detected ductal carcinoma in situ (DCIS) and invasive breast cancers divided by the total number of screened participants.
13 secondary outcomes
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.
Post-screening management adherence
Time frame: After participating in the screening, the subjects will be followed up for 24 months.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Screening of the subjects was conducted using an ultrasonic robot. in people with Breast Cancer and Ultrasound, run by Huazhong University of Science and Technology at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoxv Yin, Doctor (86+13871187781, yxx@hust.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The detection rate of breast cancer (time frame: After participating in the screening, the subjects will be followed up for 24 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.