Can new breast imaging cut unnecessary Follow-Ups for benign lesions?
NCT ID NCT07804147
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.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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30 people
The number who actually took part.
- Started
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Jul 2026
- Expected to finish
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Feb 2027
An estimate. End dates often move.
- Lead sponsor
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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
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Children (under 18), adults (18 to 64) and older adults (65 and over)
- Sex
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Female participants only
- Healthy volunteers
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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 Hide 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
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Faculty of Medicine Sohag University
Sohag, Sohag Governorate, 0000, Egypt
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