New breast scanner tested on 1,500 volunteers

NCT ID NCT02948361

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Summary

This study is testing a new ultrasound device for breast imaging in 1,500 volunteers aged 18 and older. Participants receive a scan with the QT Ultrasound Breast Scanner, and if any findings appear, standard imaging like mammograms is also done for comparison. The goal is to see how well the new scanner detects breast calcifications, masses, or other findings.

What this could mean

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

Active substance
QT Ultrasound Breast Scan (imaging device)
What this could lead to
If successful, this could provide a new, radiation-free way to screen for breast abnormalities.
What could go wrong
This is an early device-testing study, not a treatment trial. It may not prove better than existing methods, and results may not apply to all populations.

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 1,500 people

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

Started

Aug 2016

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * At least 18 years old * Willing and able to provide written, signed informed consent * Willing and able to comply with all study procedures Exclusion Criteria: * Inability to tolerate the scan * Present infection risk * Allergies to device materials * Inability to successfully "fit" breast into the investigational device * Currently pregnant as reported by the subject * Body weight greater than 400 lbs. (180 kg) * Any other conditions that the Investigator determines to interfere with the conduct of the study or evaluation of results

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As listed by the trial registrant

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

How to take part

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

  1. The places running it

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

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Marin Breast Health Trial Center

    Novato, California, 94949, United States