Handheld ultrasound could cut unnecessary breast biopsies

NCT ID NCT07407153

Diagnosis Sponsor: International Agency for Research on Cancer Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study in Indonesia will test whether a portable ultrasound device can help doctors quickly decide if a breast lump found during a physical exam is likely benign or possibly cancerous. 600 women with breast lumps will get an ultrasound at a primary care clinic. The goal is to see if this approach can safely reduce the number of women who need to go for mammograms or biopsies, easing the burden on hospitals.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: portable ultrasound device
What this could lead to: If successful, this could provide a simple, low-cost way to quickly tell if a breast lump is likely benign or cancerous, reducing unnecessary procedures.
What could go wrong: This is a small pilot study, so results may not apply broadly. The ultrasound device may not be accurate enough to replace standard diagnostic methods.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jun 2025

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

30 to 69 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

1 site. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

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A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Handheld ultrasound could cut unnecessary breast biopsies

What the study statuses mean