Portable ultrasound to sort breast lumps found on clinical exam
Ultrasound Based Triaging of Women With Breast Lump on Clinical Breast Examination: A Pilot Study, Indonesia, 2025-28
This project will try using a hand-held ultrasound at primary clinics to see if trained medical officers can separate likely-benign breast lumps from those needing more tests in women who have a lump on clinical breast exam.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 600 (estimated) |
| Ages | 30 Years to 69 Years |
| Sex | Female |
| Sponsor | International Agency for Research on Cancer Academic / other |
| Locations | 1 site (Jakarta, West Jakarta) |
| Trial ID | NCT07407153 on ClinicalTrials.gov |
What this trial studies
Nested in Indonesia's national breast screening program, this prospective project trains medical officers at primary health facilities to use a hand-held ultrasound to triage women with lumps found on clinical breast examination. Women with lumps will be classified as likely benign or potentially malignant at the point of care, with benign cases avoiding immediate referral for mammography or biopsy. The study will measure predictive values, sensitivity and specificity of the ultrasound-based triage, follow early outcomes of those spared further evaluation, and assess feasibility and acceptability of the approach. The goal is to reduce workload at tertiary radiology and pathology centers and limit unnecessary procedures for women with benign lesions.
Who should consider this trial
Good fit: Women eligible for the national breast screening program who are found to have a breast lump on clinical breast examination, can provide informed consent, and are likely to comply with study follow-up are ideal candidates.
Not a fit: Women with recent screening within three years, a known history of breast cancer or breast surgery, clear high-probability cancer symptoms, debilitating illness, or inability to consent are excluded and unlikely to benefit from this triage approach.
Why it matters
Potential benefit: If successful, this approach could reduce unnecessary mammograms and biopsies and lower the burden on tertiary centers while preserving timely care for women with suspicious lumps.
How similar studies have performed: Hand-held ultrasound for characterizing breast lumps has shown promise in prior studies, but using trained medical officers at primary-care sites for formal triage is less well studied and still being validated.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Women eligible for breast cancer screening as per the National screening programme in the country, and those detected with a breast lump on clinical breast examination Exclusion Criteria: * Women already screened in the last three years * Women with known history of breast cancer or breast surgery * Symptomatic with high probability of breast cancer diagnosis (ulcerated lump, blood-stained nipple discharge etc.) * Debilitating illness * Unable to provide informed consent due to certain mental illnesses * Unlikely to be compliant to study procedures and/or follow up as determined by the investigator
Where this trial is running
Jakarta, West Jakarta
- Dharmais hospital — Jakarta, West Jakarta, Indonesia (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.