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New mammogram tech put to the test in 7,500 women

NCT ID NCT05199701

Diagnosis Sponsor: Hologic, Inc. Source: ClinicalTrials.gov ↗

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
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing a new mammography device to see if it can safely produce clear images for breast cancer screening and diagnosis. About 7,500 women aged 35 and older who need a mammogram or breast biopsy will get an extra scan with the new device. The goal is to check image quality, safety, and comfort, which could help improve future breast cancer detection.

What this could mean

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

Active substance
new mammography device
What this could lead to
If successful, this could lead to safer and more effective mammography for breast cancer detection.
What could go wrong
This is an early-stage device study focused on image quality and safety, not on improving cancer outcomes. It may not show clear benefits over existing 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 7,500 people

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

Started

Dec 2021

Expected to finish

Nov 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

35 to 100 years

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: * Subject is female of any race and ethnicity. * Subject is at least 35 years old. * Subject is indicated for a screening or diagnostic mammogram or breast biopsy. Exclusion Criteria: * Subject is pregnant or thinks she may be pregnant * Subject has breast implants, cardiac pacemakers, nipple piercings, or IV ports in the mammography field of view. * Subject previously participated in the study.

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Conditions

The condition(s) this trial relates to.

breast cancer

As listed by the trial registrant

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

Mammography

Contacts and locations

Locations

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234, United States

  • Baptist Health

    Louisville, Kentucky, 40207, United States

  • Corewell Health

    Grand Rapids, Michigan, 49503, United States

  • Diagnostic Centers of America Palm Beach Gardens

    Palm Beach Gardens, Florida, 33410, United States

  • Diagnostic Centers of America West Palm Beach

    West Palm Beach, Florida, 33401, United States

  • Elizabeth Wendy Breast Care

    Rochester, New York, 14620, United States

  • Miami Breast Institute

    Coral Gables, Florida, 33146, United States

  • Progressive Radiology

    Bel Air, Maryland, 21014, United States

  • Scottsdale Medical Imaging LTD

    Scottsdale, Arizona, 85251, United States

  • Solis Mammography Burleson

    Burleson, Texas, 76028, United States

  • Solis Mammography Columbus

    Columbus, Ohio, 43214, United States

  • Solis Mammography Greensboro

    Greensboro, North Carolina, 27401, United States

  • Southwest Medical Imaging

    Gilbert, Arizona, 85297, United States

  • Washington Radiology

    Arlington, Virginia, 22201, United States

  • Washington Radiology

    Sterling, Virginia, 20166, United States

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