Comparison of Conspicuity of Masses and Architectural Distortions Between Wide- and Narrow-angle Digital Breast Tomosynthesis Systems
NCT ID: NCT06373354
Last Updated: 2025-10-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
100 participants
OBSERVATIONAL
2024-10-18
2027-12-31
Brief Summary
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Detailed Description
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\- 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
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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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.
Digital Breast Tomosynthesis (DBT)
Undergo tomosynthesis imaging
Interventions
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Digital Breast Tomosynthesis (DBT)
Undergo tomosynthesis imaging
Eligibility Criteria
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Inclusion Criteria
* Ability to understand and sign consent.
Exclusion Criteria
* Women unable to consent.
* Male patients.
FEMALE
No
Sponsors
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Siemens Medical Solutions
INDUSTRY
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Beatriz Adrada, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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MD Anderson Cancer Center
Houston, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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MD Anderson Cancer Center
Other Identifiers
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NCI-2024-03341
Identifier Type: OTHER
Identifier Source: secondary_id
2023-0924
Identifier Type: -
Identifier Source: org_study_id
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