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 range
40 Years
Sex
FEMALE
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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.