Can new breast imaging cut unnecessary Follow-Ups for benign lesions?

NCT ID NCT07804147

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 04, 2026 ยท Last updated Sep 04, 2026

Summary

This trial tests whether combining breast ultrasound with digital mammography, or using digital breast tomosynthesis, can better classify breast lesions that are initially labeled probably benign (BI-RADS 3). Researchers will enroll 30 women with dense breasts and non-calcified lesions. Each participant will undergo both imaging approaches, and doctors will compare how often the lesions get reclassified as either lower risk (BI-RADS 2) or higher risk. The goal is to see if these methods can reduce unnecessary short-interval follow-ups while catching lesions that need more attention.

What this could mean

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

Active substance
Combined breast ultrasound and digital mammography, and digital breast tomosynthesis (imaging procedures)
What this could lead to
If it works, this could help doctors tell which probably benign breast lesions need closer watching and which can skip extra follow-up visits, easing anxiety and reducing unnecessary procedures.
What could go wrong
This is a small, early study with only 30 participants, so the results may not apply to all women. The imaging methods might not clearly reclassify many lesions, and the study does not track long-term outcomes.

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

30 people

The number who actually took part.

Started

Jul 2026

Expected to finish

Feb 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.

Who is studied

The study population will consist of 30 female patients presenting with at least one non-calcified breast lesion initially classified as BI-RADS 3 (probably benign) on standard 2D digital mammography. Patients with breast densities B, C, or D will be included, with particular consideration of dense breasts (C and D). All eligible participants will undergo complementary targeted breast ultrasound and digital breast tomosynthesis for lesion evaluation and BI-RADS reclassification.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: 1. \- Radiological classification: Patients with at least one non-calcified breast lesion initially classified as BI-RADS 3 (probably benign) on standard 2D digital mammography. 2. \- Breast density: Patients with breast densities B, C, or D are eligible, with particular consideration of dense breasts (C and D). Exclusion Criteria: * Suspicious imaging features: Patients with any lesion demonstrating BI-RADS 4 or 5 characteristics, including spiculated margins, fine linear branching calcifications, or architectural distortion.

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As listed by the trial registrant

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

Contacts and locations

Locations

  • Faculty of Medicine Sohag University

    Sohag, Sohag Governorate, 0000, Egypt

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