Breast - FemaleNCT07804147
Evaluation and Reclassification of ( BI-RADS 3) Breast Lesions in Dense Breast
An observational study of Breast - Female and Dense Breast Parenchyma, run by Sohag University at 1 site in Egypt.
Trial summary
This prospective study aims to compare combined breast ultrasound (US) and digital mammography (DM) with digital breast tomosynthesis (DBT) in the evaluation and reclassification of BI-RADS 3 (probably benign) breast lesions. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast - Female, Dense Breast Parenchyma, Breast Lesion
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 12 Jul 2026to 1 Feb 2027
- How long will I take part?
- 6 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: 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.
Who may be able to join
- - Radiological classification: Patients with at least one non-calcified breast lesion initially classified as BI-RADS 3 (probably benign) on standard 2D digital mammography.
- - Breast density: Patients with breast densities B, C, or D are eligible, with particular consideration of dense breasts (C and D).
Who cannot join
- Suspicious imaging features:
- Patients with any lesion demonstrating BI-RADS 4 or 5 characteristics, including spiculated margins, fine linear branching calcifications, or architectural distortion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combined Ultrasound and Digital Mammography Versus Digital Breast Tomosynthesis in the Evaluation and Reclassification of ( BI-RADS 3) Breast Lesions in Dense Breast
This prospective study aims to compare combined breast ultrasound (US) and digital mammography (DM) with digital breast tomosynthesis (DBT) in the evaluation and reclassification of BI-RADS 3 (probably benign) breast lesions. The study will include 30 female patients with non-calcified breast lesions initially classified as BI-RADS 3 on digital mammography. Patients will undergo complementary targeted breast ultrasound and DBT. The imaging findings will be assessed separately and then integrated to determine the final BI-RADS classification. The study will evaluate whether DBT and combined US with DM can improve characterization and reclassification of BI-RADS 3 lesions, potentially reducing unnecessary short-interval follow-up while identifying lesions requiring further assessment.
Read the detailed description
BI-RADS category 3 lesions are considered probably benign findings but generally require short-interval imaging follow-up to document stability. This may result in additional examinations and patient anxiety. The study will investigate the role of digital breast tomosynthesis (DBT) compared with combined ultrasound (US) and digital mammography (DM) in the assessment and reclassification of these lesions, particularly in patients with dense breast tissue.
This is a prospective study to be conducted at Sohag University Hospital. The study population will consist of 30 female patients presenting with at least one non-calcified breast lesion initially classified as BI-RADS 3 on standard 2D digital mammography. Patients with breast densities B, C, or D will be eligible, with particular consideration of dense breasts (C and D).
All patients will undergo baseline 2D digital mammography, followed by complementary targeted breast ultrasound using a high-resolution linear-array transducer. Ultrasound assessment will include evaluation of lesion shape, orientation, margins, echo pattern, and posterior acoustic features, with a separate US-based BI-RADS assessment.
Patients will also undergo digital breast tomosynthesis using standard bilateral craniocaudal and mediolateral oblique views, with reconstruction into 1-mm slices. DBT assessment will include evaluation of lesion margins and assessment for associated architectural distortion or microcalcifications that may not be apparent on 2D mammography. A separate DBT-based BI-RADS assessment will be assigned.
The imaging findings will subsequently undergo an integrated assessment. The protocol includes independent assessment of US and DBT findings followed by assignment of a final BI-RADS category based on the combined findings. Reclassification may include downgrading a finding when DBT demonstrates that an apparent mammographic asymmetry represents overlapping normal breast tissue, or upgrading a lesion when suspicious ultrasound features such as non-parallel orientation or angular margins are identified.
Diagnostic performance measures, including sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated for US and DBT. Data will be analyzed using SPSS software.
- Keywords
- breast, dense breast, probably benign breast lesions, BIRADs 3, breast lesions reassessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| BI-RADS 3 Breast Lesion Cohort | Female patients with at least one non-calcified breast lesion initially classified as BI-RADS 3 (probably benign) on digital mammography. Participants undergo complementary targeted breast ultrasound and digital breast tomosynthesis for evaluation and reclassification of the lesion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BI-RADS classification of breast lesions
The proportion of initially BI-RADS 3 breast lesions that are reclassified following assessment with digital breast tomosynthesis and complementary breast ultrasound, including downgrading to BI-RADS 2 or upgrading to a higher BI-RADS category based on imaging findings.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2026
- Study start12 Jul 2026
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast - FemaleStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nada Mahmoud Abdellah, Sohag University
- Investigators
- Mohamad Zaki Ali, Professor, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07804147
- Sponsor's protocol ID
- Soh-Med-26-7-16MS
- Status last verified
- Sep 2026
- First submitted
- 27 Aug 2026
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because no individual participant data sharing plan has been established for this study. Study data will be used for the purposes of the research and statistical analysis described in the study protocol.
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Ultrasound and Digital Mammography Versus Digital Breast Tomosynthesis in the Evaluation and Reclassification of ( BI-RADS 3) Breast Lesions in Dense Breast
- ClinicalTrials.gov ID
- NCT07804147
- Acronym / sponsor ID
- Soh-Med-26-7-16MS
- Keywords
- breast, dense breast, probably benign breast lesions, BIRADs 3, breast lesions reassessment
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 12 Jul 2026 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 4 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This prospective study aims to compare combined breast ultrasound (US) and digital mammography (DM) with digital breast tomosynthesis (DBT) in the evaluation and reclassification of BI-RADS 3 (probably benign) breast lesions. The study will include 30 female patients with non-calcified breast lesions initially classified as BI-RADS 3 on digital mammography. Patients will undergo complementary targeted breast ultrasound and DBT. The imaging findings will be assessed separately and then integrated to determine the final BI-RADS classification. The study will evaluate whether DBT and combined US with DM can improve characterization and reclassification of BI-RADS 3 lesions, potentially reducing unnecessary short-interval follow-up while identifying lesions requiring further assessment.
Detailed description
BI-RADS category 3 lesions are considered probably benign findings but generally require short-interval imaging follow-up to document stability. This may result in additional examinations and patient anxiety. The study will investigate the role of digital breast tomosynthesis (DBT) compared with combined ultrasound (US) and digital mammography (DM) in the assessment and reclassification of these lesions, particularly in patients with dense breast tissue.
This is a prospective study to be conducted at Sohag University Hospital. The study population will consist of 30 female patients presenting with at least one non-calcified breast lesion initially classified as BI-RADS 3 on standard 2D digital mammography. Patients with breast densities B, C, or D will be eligible, with particular consideration of dense breasts (C and D).
All patients will undergo baseline 2D digital mammography, followed by complementary targeted breast ultrasound using a high-resolution linear-array transducer. Ultrasound assessment will include evaluation of lesion shape, orientation, margins, echo pattern, and posterior acoustic features, with a separate US-based BI-RADS assessment.
Patients will also undergo digital breast tomosynthesis using standard bilateral craniocaudal and mediolateral oblique views, with reconstruction into 1-mm slices. DBT assessment will include evaluation of lesion margins and assessment for associated architectural distortion or microcalcifications that may not be apparent on 2D mammography. A separate DBT-based BI-RADS assessment will be assigned.
The imaging findings will subsequently undergo an integrated assessment. The protocol includes independent assessment of US and DBT findings followed by assignment of a final BI-RADS category based on the combined findings. Reclassification may include downgrading a finding when DBT demonstrates that an apparent mammographic asymmetry represents overlapping normal breast tissue, or upgrading a lesion when suspicious ultrasound features such as non-parallel orientation or angular margins are identified.
Diagnostic performance measures, including sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated for US and DBT. Data will be analyzed using SPSS software.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Months
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BI-RADS 3 Breast Lesion Cohort | – | –Female patients with at least one non-calcified breast lesion initially classified as BI-RADS 3 (probably benign) on digital mammography. Participants undergo complementary targeted breast ultrasound and digital breast tomosynthesis for evaluation and reclassification of the lesion. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 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.
Key inclusion criteria (2 listed)
- - Radiological classification: Patients with at least one non-calcified breast lesion initially classified as BI-RADS 3 (probably benign) on standard 2D digital mammography.
- - Breast density: Patients with breast densities B, C, or D are eligible, with particular consideration of dense breasts (C and D).
Key exclusion criteria (2 listed)
- Suspicious imaging features:
- Patients with any lesion demonstrating BI-RADS 4 or 5 characteristics, including spiculated margins, fine linear branching calcifications, or architectural distortion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in BI-RADS classification of breast lesions
Time frame: through study completion, an average of 1 year
The proportion of initially BI-RADS 3 breast lesions that are reclassified following assessment with digital breast tomosynthesis and complementary breast ultrasound, including downgrading to BI-RADS 2 or upgrading to a higher BI-RADS category based on imaging findings.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because no individual participant data sharing plan has been established for this study. Study data will be used for the purposes of the research and statistical analysis described in the study protocol.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamad Zaki Ali, Professor study director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast - Female and Dense Breast Parenchyma, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in BI-RADS classification of breast lesions (time frame: through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.