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AI may slash unnecessary breast biopsies

NCT ID NCT05767424

Diagnosis Sponsor: Istituti Clinici Scientifici Maugeri SpA Source: ClinicalTrials.gov ↗

What the study statuses mean

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether artificial intelligence can accurately classify breast microcalcifications seen on mammograms as benign or malignant. Microcalcifications are common and often prompt a biopsy, but only a few turn out to be cancer. The researchers will also explore combining AI with Raman spectroscopy, a laser-based technique, to identify the molecular makeup of microcalcifications. If successful, this approach could reduce unnecessary biopsies and speed up diagnosis.

What this could mean

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

Active substance
Artificial intelligence-based classification of mammographic images, combined with Raman spectroscopy for biomolecular characterization
What this could lead to
If successful, this could lead to a non-invasive diagnostic tool that reduces unnecessary breast biopsies and provides rapid, accurate characterization of suspicious microcalcifications.
What could go wrong
This is an observational study, not a treatment trial, so it won't directly change patient outcomes. The AI's accuracy needs validation, and it may not generalize to all populations or imaging equipment.

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.

Participants

About 1,426 people

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

Started

Jul 2022

Expected to finish

Jul 2028

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.

Who is studied

Breast patological patients who experience microcalcification lesion

Ages

18 to 88 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

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: * Female subjects; * Age between 18 and 88 years; * Detection of microcalcifications on clinical and screening mammography with or without indication for histological assessment by biopsy; * Subjects who agree to participate in the study by signing and dating the Informed Consent form Exclusion Criteria: * Personal history of breast cancer

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm calcinosis

As listed by the trial registrant

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

Breast cancer Microcalcification

Contacts and locations

Locations

  • Istituti Clinici Scientifici Maugeri SpA

    Pavia, Lombardy, 27100, Italy

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