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Massive study tests if 3D mammograms find more breast cancers

NCT ID NCT03377036

Diagnosis Sponsor: University Hospital Muenster 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This large study compares two types of mammograms for breast cancer screening: a newer 3D method (digital breast tomosynthesis plus synthesized 2D images) and the standard 2D digital mammogram. About 100,000 women eligible for Germany's national screening program took part. The goal is to see if the 3D method detects more invasive breast cancers and reduces the number of cancers that appear between screenings.

What this could mean

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

Active substance
Digital breast tomosynthesis (3D mammography) plus synthesized 2D images
What this could lead to
If successful, this could show that 3D mammography detects more invasive breast cancers and reduces the number of cancers missed between screenings, potentially improving early detection.
What could go wrong
This is a screening comparison, not a treatment trial. Even if 3D mammography finds more cancers, it may also increase false alarms or overdiagnosis. Results may not apply to all populations or screening programs.

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

99,689 people

The number who actually took part.

Started

Jul 2018

Expected to finish

Mar 2027

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

50 to 69 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 eligible to participate in the National Mammography Screening Program of Germany * Informed decision for mammography screening * Written informed consent * No prior participation in the TOSYMA trial Exclusion Criteria: * Breast cancer up to 5 years prior to study invitation * Previous mammography examination \< 12 months, * Breast implants

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Conditions

The condition(s) this trial relates to.

breast neoplasm

As listed by the trial registrant

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

Breast cancer screening

Contacts and locations

Locations

  • Referenz-Screeening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Münster-Nord

    Münster, North Rhine-Westphalia, 48143, Germany

  • Referenz-Screening-Einheit Münster-Nord/Warendorf; Mammographie-Einheit Ahlen

    Ahlen, North Rhine-Westphalia, 59227, Germany

  • Screening-Einheit Aachen-Düren-Heinsberg; Mammographie-Einheit Aachen

    Aachen, North Rhine-Westphalia, 52062, Germany

  • Screening-Einheit Bielefeld, Gütersloh; Mammographie-Einheit Bielefeld

    Bielefeld, North Rhine-Westphalia, 33062, Germany

  • Screening-Einheit Duisburg; Mammographie-Einheit Duisburg

    Duisburg, North Rhine-Westphalia, 47057, Germany

  • Screening-Einheit Gelsenkirchen, Kreis Recklinghausen, Bottrop; Mammographie-Einheit Gelsenkirchen

    Gelsenkirchen, North Rhine-Westphalia, 45894, Germany

  • Screening-Einheit Hannover; Mammographie-Einheit Hannover

    Hanover, Lower Saxony, 30449, Germany

  • Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Lippstadt

    Lippstadt, North Rhine-Westphalia, 59555, Germany

  • Screening-Einheit Höxter, Paderborn, Soest; Mammographie-Einheit Paderborn

    Paderborn, North Rhine-Westphalia, 33098, Germany

  • Screening-Einheit Köln rechtsrheinisch, Leverkusen, Rhein.-Berg. Kreis, Oberbergischer Kreis; Mammographie-Einheit Bergisch Gladbach

    Bergisch Gladbach, North Rhine-Westphalia, 51429, Germany

  • Screening-Einheit Minden-Lübbecke, Herford; Mammographie-Einheit Herford

    Herford, North Rhine-Westphalia, 32052, Germany

  • Screening-Einheit Märkischer Kreis, Hamm, Unna; Mammographie-Einheit Schwerte

    Schwerte, North Rhine-Westphalia, 58239, Germany

  • Screening-Einheit Mönchengladbach, Krefeld, Viersen; Mammographie-Einheit Krefeld

    Krefeld, North Rhine-Westphalia, 47805, Germany

  • Screening-Einheit Münster-Süd; Mammographie-Einheit Coesfeld

    Coesfeld, North Rhine-Westphalia, 48653, Germany

  • Screening-Einheit Münster-Süd; Mammographie-Einheit Münster

    Münster, North Rhine-Westphalia, 48153, Germany

  • Screening-Einheit Niedersachsen Mitte; Mammographie-Einheit Vechta

    Vechta, Lower Saxony, 49377, Germany

  • Screening-Einheit Niedersachsen Nord; Mammographie-Einheit Stade

    Stade, Lower Saxony, 21680, Germany

  • Screening-Einheit Niedersachsen Nordost; Mammographie-Einheit Lüneburg

    Lüneburg, Lower Saxony, 21337, Germany

  • Screening-Einheit Niedersachsen Nordwest; Mammographie-Einheit Wilhelmshaven

    Wilhelmshaven, Lower Saxony, 26382, Germany

  • Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Solingen-Mitte

    Solingen, North Rhine-Westphalia, 42651, Germany

  • Screening-Einheit Raum Bergisch Land/Kreis Mettmann; Mammographie-Einheit Wuppertal-Elberfeld

    Wuppertal, North Rhine-Westphalia, 42109, Germany

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