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Acquisition and Clinical Image Evaluation of Fujifilm's High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images.
RecruitingHealthy volunteers welcome
Acquisition and Clinical Image Evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images
Who can join
Ages 40 and older · Women · Healthy volunteers welcome
Full eligibility criteria
Inclusion Criteria: * Have the ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol; * Have the ability to understand and provide written authorization for the use and disclosure of protected health information (PHI) per the Health Insurance Portability and Accountability Act (HIPAA) privacy ruling; * Be female; * Be at least 40 years of age; * Be asymptomatic; and * Have received a final BI-RADS Assessment Category of 1 or 2 (negative or benign findings) on her routine screening mammogram. Exclusion Criteria: * Has a breast implant; * Is pregnant or believes she may be pregnant; * Has delivered and expressed the intention to breast-feed or is currently breast-feeding; * Has significant existing breast trauma with the last one (1) year; * Has any breast symptoms (e.g., breast lump, pain, nipple discharge); * Has been diagnosed or treated for breast cancer within the last year; or * Is an inmate (see US Code of Federal Regulations 45 CFR 46.306).
About the study
Acquisition and clinical image evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) images.
What is being tested
- DBT HR mode image acquisition (device)
Sponsor: Fujifilm Medical Systems USA, Inc. · Participants: 18 · Started: Jul 20, 2026
Contact the study team
- Nicole M. Calabrese, MS · Phone: 518-506-9840
Official record on ClinicalTrials.gov — NCT07471750
Locations in the U.S.
| Utah | University of Utah - Sugarhouse Clinic, Salt Lake City |
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.