Three DimensionNCT07145892
Three-dimensional Digital Breast Tomosynthesis Versus Digital Mammography
An observational study of Three Dimension and Digital Tomosynthesis, run by The General Authority for Teaching Hospitals and Institutes at 1 site in Egypt.
Trial summary
This study aimed to compare the supremacy of (3D) tomosynthesis versus (2D) digital mammography in the diagnosis of benign breast lesions in asymptomatic females. Read more about this study
- Who is it for?
- Ages 30 years and older, women only
- Conditions the study is for
- Three Dimension, Digital Tomosynthesis, Digital Mammography
- What is being tested?
- Three-dimensional Digital Breast Tomosynthesis and Two-dimensional Digital Mammography
- Type of treatment
- Medical device
- How many people
- 255 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 29 May 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 30 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: This retrospective study was conducted on patients referred to the Diagnostic Radiology Department at Damanhur Educational Hospital and Tanta University.
Who may be able to join
- Women with benign breast lesions.
Who cannot join
- Pregnant and lactating female.
- Patients who refuse to fill the consent form.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Three-dimensional Digital Breast Tomosynthesis Versus Digital Mammography: Which Get the Supremacy in Diagnosis of Benign Breast Lesions in Asymptomatic Females
This study aimed to compare the supremacy of (3D) tomosynthesis versus (2D) digital mammography in the diagnosis of benign breast lesions in asymptomatic females.
Read the detailed description
Most of the breast lesions are benign, but much concern is given to malignant lesions because breast cancer is the most common malignancy in women.
Mammography is the only study for screening in asymptomatic patients, and it is the initial imaging study in the diagnosis of symptomatic patients, with a sensitivity for suspicious lesions of 86% and a specificity of 57%.
In recent years, a significant effort has been expended to develop new approaches to breast imaging, one of which is the use of digital breast tomosynthesis (DBT), which is a pseudo three-dimensional digital mammography system that produces a series of thin-section reconstructed images from low-dose X-ray projections at multiple angles.
- Conditions
- Three Dimension, Digital Tomosynthesis, Digital Mammography, Diagnosis, Benign Breast Lesions, Asymptomatic Females
- Being tested
- Three-dimensional Digital Breast Tomosynthesis, Two-dimensional Digital Mammography
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Three-dimensional Digital Breast TomosynthesisDevice
Patients underwent three-dimensional digital breast tomosynthesis.
Two-dimensional Digital MammographyDevice
Patients underwent two-dimensional digital mammography
| Study group | Role | What they receive |
|---|---|---|
| Group I | Categorized 130 women aged from 30 to 40 years. Receives: Device: Three-dimensional Digital Breast Tomosynthesis; Device: Two-dimensional Digital Mammography | |
| Group II | Categorized 115 women aged from 40 to 50 years. Receives: Device: Three-dimensional Digital Breast Tomosynthesis; Device: Two-dimensional Digital Mammography | |
| Group III | Categorized 10 females aged above 50 years. Receives: Device: Three-dimensional Digital Breast Tomosynthesis; Device: Two-dimensional Digital Mammography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation between imaging findings and the final diagnosis
Correlation between imaging findings and the final diagnosis was calculated.
Measured: 6 months post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2025
- Study start1 Jun 2024
- Primary completion29 May 2025
- Study completion29 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Three DimensionStudies of the same condition, open and under way.
- 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- The General Authority for Teaching Hospitals and Institutes
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Hekmat Samir Baumey, The General Authority for Teaching Hospitals and Institutes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07145892
- Sponsor's protocol ID
- HD000217
- Status last verified
- Aug 2025
- First submitted
- 21 Aug 2025
- Last updated
- 28 Aug 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Digital Breast Tomosynthesis Versus Digital Mammography: Which Get the Supremacy in Diagnosis of Benign Breast Lesions in Asymptomatic Females
- ClinicalTrials.gov ID
- NCT07145892
- Acronym / sponsor ID
- HD000217
- Conditions
- Three Dimension, Digital Tomosynthesis, Digital Mammography, Diagnosis, Benign Breast Lesions, Asymptomatic Females
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- The General Authority for Teaching Hospitals and InstitutesResearch network
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 29 May 2025 (actual)
- Study completion
- 29 May 2025 (actual)
- First posted
- 28 Aug 2025 (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 study aimed to compare the supremacy of (3D) tomosynthesis versus (2D) digital mammography in the diagnosis of benign breast lesions in asymptomatic females.
Detailed description
Most of the breast lesions are benign, but much concern is given to malignant lesions because breast cancer is the most common malignancy in women.
Mammography is the only study for screening in asymptomatic patients, and it is the initial imaging study in the diagnosis of symptomatic patients, with a sensitivity for suspicious lesions of 86% and a specificity of 57%.
In recent years, a significant effort has been expended to develop new approaches to breast imaging, one of which is the use of digital breast tomosynthesis (DBT), which is a pseudo three-dimensional digital mammography system that produces a series of thin-section reconstructed images from low-dose X-ray projections at multiple angles.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I | – | Device: Three-dimensional Digital Breast Tomosynthesis, Device: Two-dimensional Digital MammographyCategorized 130 women aged from 30 to 40 years. |
| Group II | – | Device: Three-dimensional Digital Breast Tomosynthesis, Device: Two-dimensional Digital MammographyCategorized 115 women aged from 40 to 50 years. |
| Group III | – | Device: Three-dimensional Digital Breast Tomosynthesis, Device: Two-dimensional Digital MammographyCategorized 10 females aged above 50 years. |
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This retrospective study was conducted on patients referred to the Diagnostic Radiology Department at Damanhur Educational Hospital and Tanta University.
Key inclusion criteria (1 listed)
- Women with benign breast lesions.
Key exclusion criteria (2 listed)
- Pregnant and lactating female.
- Patients who refuse to fill the consent form.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Three-dimensional Digital Breast TomosynthesisPatients underwent three-dimensional digital breast tomosynthesis. | Device | Group I, Group II, Group III |
| Two-dimensional Digital MammographyPatients underwent two-dimensional digital mammography | Device | Group I, Group II, Group III |
Primary outcome
Correlation between imaging findings and the final diagnosis
Time frame: 6 months post-procedure
Correlation between imaging findings and the final diagnosis was calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2025.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Three Dimension and Digital Tomosynthesis, run by The General Authority for Teaching Hospitals and Institutes 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 1 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: finished, as of the sponsor's last update on 28 Aug 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Correlation between imaging findings and the final diagnosis (time frame: 6 months post-procedure). 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 28 Aug 2025.