New breast scanner tested on 1,500 volunteers
NCT ID NCT02948361
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
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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
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About 1,500 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2016
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Female participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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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.
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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.
Contacts and locations
Locations
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Marin Breast Health Trial Center
Novato, California, 94949, United States