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Can 3D breast imaging spot more dangerous cancers than standard mammograms?

NCT ID NCT04461808

Diagnosis Sponsor: Azienda USL Reggio Emilia - IRCCS 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 24, 2026 · Last updated Jul 24, 2026

Summary

This trial tests whether tomosynthesis (a 3D X-ray technique) combined with synthetic 2D images can reduce the number of advanced and interval breast cancers compared to standard digital mammography. Over 10,000 women scheduled for routine screening will be randomly assigned to one of the two methods. The goal is to see if the newer technology catches more aggressive tumors early, when they are easier to treat.

What this could mean

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

Active substance
tomosynthesis plus synthetic 2D mammography
What this could lead to
If tomosynthesis proves better at catching aggressive cancers early, it could become a new standard for breast cancer screening, potentially reducing deaths.
What could go wrong
This is a single-round screening comparison, so long-term benefits are not yet known. Tomosynthesis may also increase false alarms or overdiagnosis.

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

10,156 people

The number who actually took part.

Started

Mar 2019

Expected to finish

Apr 2029

An estimate. End dates often move.

Lead sponsor

A government agency

The lead sponsor is a government body.

Who can take part

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

Ages

45 to 65 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: * Women scheduled for a new round of mammographic screening * resident in the province Exclusion Criteria: * previous breast cancer diagnosis * pregnancy or suspicion of pregnancy * presence of BRCA1/2 gene mutation * Previous Digital Breast Tomosynthesis performed * unable to understand informed consent * chemotherapy in progress * presence of breast implant

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Conditions

The condition(s) this trial relates to.

breast neoplasm breast cancer prevention target

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • Azienda Ospedaliera Universitaria Integrata

    Verona, Italy

  • Azienda Ulss 9 Scaligera

    Verona, Italy

  • Azienda Unità Sanitaria Locale - IRCCS di Reggio Emilia

    Reggio Emilia, Italy, 42122, Italy

  • IRCCS Policlinico San Donato

    Milan, Italy

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