Architectural DistortionsNCT06373354
Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
An observational study of Architectural Distortions and Breast Tomosynthesis, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Architectural Distortions, Breast Tomosynthesis
- What is being tested?
- Digital Breast Tomosynthesis (DBT)
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Oct 2024to 31 Dec 2027
- 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: Screening mammography population at MD Anderson
Who may be able to join
- Women undergoing standard screening mammography.
- Ability to understand and sign consent.
Who cannot join
- Pregnant women.
- Women unable to consent.
- Male patients.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
MD Anderson Cancer Center
Houston, Texas, 77030
Beatriz Adrada, MD, 713-792-2709, beatriz.adrada@mdanderson.org
Beatriz Adrada, MD
About this study
To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT.
Read the detailed description
Primary Objectives
- The primary objective of this proposed study is to show that bWBT (B.brilliant wide-angle breast tomosynthesis) images provide better lesion conspicuity for masses and architectural distortions than NBT images based on the standard screening tomosynthesis imaging.
Secondary Objectives
- The secondary objective of this proposed study is to show that WBT images provide better lesion conspicuity for masses and architectural distortions based on the standard screening tomosynthesis imaging.
- Additional secondary objectives include radiologist feedback on the B.brilliant images, technologist experience with B.brilliant, and a participant comfort survey.
- Conditions
- Architectural Distortions, Breast Tomosynthesis
- Being tested
- Digital Breast Tomosynthesis (DBT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Breast Tomosynthesis (DBT)Device
Undergo tomosynthesis imaging
| Study group | Role | What they receive |
|---|---|---|
| Digital Breast Tomosynthesis (DBT) | Participants that agree to take part in this study, your standard follow-up imaging will be done using an FDA approved DBT system, but it will be different from the DBT system used for your routine screening. For example, if narrow-angle DBT was used for your routine screening, then you will have standard wide-angle DBT. If wide-angle DBT used for your routine screening, then you will have narrow-angle DBT. These images will be used for diagnosis and to help decide your further care. Receives: Device: Digital Breast Tomosynthesis (DBT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and adverse events (AEs)
ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
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 posted18 Apr 2024
- Study start18 Oct 2024
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Architectural DistortionsStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Siemens Medical Solutions
- Responsible party
- Sponsor
- Investigators
- Beatriz Adrada, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373354
- Sponsor's protocol ID
- 2023-0924
- Other IDs
- NCI-2024-03341
- Status last verified
- Oct 2026
- First submitted
- 15 Apr 2024
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
- ClinicalTrials.gov ID
- NCT06373354
- Acronym / sponsor ID
- 2023-0924
- Conditions
- Architectural Distortions, Breast Tomosynthesis
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- Siemens Medical Solutions
- Study start
- 18 Oct 2024 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 18 Apr 2024 (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.
To compare narrow-angle digital breast tomosynthesis (DBT) and wide-angle DBT.
Detailed description
Primary Objectives
- The primary objective of this proposed study is to show that bWBT (B.brilliant wide-angle breast tomosynthesis) images provide better lesion conspicuity for masses and architectural distortions than NBT images based on the standard screening tomosynthesis imaging.
Secondary Objectives
- The secondary objective of this proposed study is to show that WBT images provide better lesion conspicuity for masses and architectural distortions based on the standard screening tomosynthesis imaging.
- Additional secondary objectives include radiologist feedback on the B.brilliant images, technologist experience with B.brilliant, and a participant comfort survey.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Digital Breast Tomosynthesis (DBT) | – | Device: Digital Breast Tomosynthesis (DBT)Participants that agree to take part in this study, your standard follow-up imaging will be done using an FDA approved DBT system, but it will be different from the DBT system used for your routine screening. For example, if narrow-angle DBT was used for your routine screening, then you will have standard wide-angle DBT. If wide-angle DBT used for your routine screening, then you will have narrow-angle DBT. These images will be used for diagnosis and to help decide your further care. |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Screening mammography population at MD Anderson
Key inclusion criteria (2 listed)
- Women undergoing standard screening mammography.
- Ability to understand and sign consent.
Key exclusion criteria (3 listed)
- Pregnant women.
- Women unable to consent.
- Male patients.
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 |
|---|---|---|
| Digital Breast Tomosynthesis (DBT)Undergo tomosynthesis imaging | Device | Digital Breast Tomosynthesis (DBT) |
Primary outcome
Safety and adverse events (AEs)
Time frame: Through study completion; an average of 1 year
ncidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events
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 7 Oct 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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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.
Beatriz Adrada, MD principal investigator
M.D. Anderson Cancer Center
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 Architectural Distortions and Breast Tomosynthesis, run by M.D. Anderson Cancer Center at 1 site in United States.
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 3 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: looking for participants now, as of the sponsor's last update on 7 Oct 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 United States. 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?
Contact Beatriz Adrada, MD ((713) 792-2709, beatriz.adrada@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety and adverse events (AEs) (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 7 Oct 2026.