Acquisition and Clinical Image Evaluation of Fujifilm's High Resolution (HR) Digital Breast Tomos… (NCT07471750) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Acquisition and Clinical Image Evaluation of Fujifilm's High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images.
18 participantsStarted 2026-03-30
Plain-language summary
Acquisition and clinical image evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) images.
Who can participate
Age range40 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
What they're measuring
1
Image Acquisition
Timeframe: Each study participant will attend a single study visit (acquisition).
2
Clinical Image Evaluation - Image quality
Timeframe: Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day.