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Clinical Trials in the USA / NCT07471750
Recruiting Not applicable

Acquisition and Clinical Image Evaluation of Fujifilm's High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images.

NCT07471750 · tracked via the Priya Life Science USA tracker
Sponsor
Fujifilm Medical Systems USA, Inc
Phase
Not applicable
Started
2026-07-20
Last updated
2026-10-14

Condition(s) studied

Routine Screening Mammography

Investigational drug(s) / intervention(s)

DBT HR mode image acquisition

DBT HR mode image acquisition: Fujifilm DBT HR image acquisition.

Study summary

Acquisition and clinical image evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) images.

Eligibility

Sex
FEMALE
Min age
40 Years
Max age
—
Healthy volunteers
Accepted
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).

Primary outcome measure(s)

  • Image Acquisition — Each study participant will attend a single study visit (acquisition).
    To acquire appropriate and sufficient cases to support the Clinical Image Evaluation part of the study.
  • Clinical Image Evaluation - Image quality — Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day.
    To determine if the DBT HR mode clinical images, when reviewed by expert radiologists, are judged to be of sufficiently acceptable overall clinical image quality for use in clinical mammography.

Trial sites (1)

FacilityCityRegionStatus
University of Utah - Sugarhouse Clinic Salt Lake City Utah Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07471750 on ClinicalTrials.gov ↗ ← All trials in the USA