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New Imaging-Guided biopsy aims to improve breast cancer detection

NCT ID NCT04862429

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
Running, but no longer taking on new participants.
Completed This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether using contrast-enhanced mammography to guide breast biopsies is more accurate than the standard X-ray-guided method for suspicious calcifications. About 184 women with suspicious calcifications (BIRADS R3-R5) were randomly assigned to one of the two biopsy techniques. The goal was to see if the new method better targets the most dangerous part of the lesion, potentially improving diagnosis and treatment planning.

What this could mean

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

Active substance
contrast-enhanced mammography guided biopsy
What this could lead to
If successful, this could make breast biopsies more accurate, reducing the need for repeat procedures and improving detection of aggressive cancers.
What could go wrong
This is a completed, moderate-sized study. The technique requires contrast dye, which carries a small risk of allergic reaction or kidney issues. It may not be widely available or change standard practice if results are not clearly superior.

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

184 people

The number who actually took part.

Started

Jul 2021

Finished

Oct 2025

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

18 years and older

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: * Women with clinical mammography and screening recalls with mammographic confirmation of clusters of suspicious calcifications (BIRADS R3 or R4 or R5) not mass-associated will be included, with indication to perform stereotactic biopsy, evaluated at the Breast Care Facility of AUSL-IRCCS in Reggio Emilia. Exclusion Criteria: * Women with contraindication to the administration of iodized contrast medium will be excluded.

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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 Calcification

Contacts and locations

Locations

  • Azienda USL - IRCCS di Reggio Emilia

    Reggio Emilia, RE, 42123, Italy

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