Routine Screening MammographyNCT07471750
Acquisition and Clinical Image Evaluation of Fujifilm's High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images.
A study testing DBT HR mode image acquisition in people with Routine Screening Mammography, run by Fujifilm Medical Systems USA, Inc. at 1 site in United States.
Trial summary
Acquisition and clinical image evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) images. Read more about this study
- Who is it for?
- Ages 40 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Routine Screening Mammography
- What is being tested?
- DBT HR mode image acquisition
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2026to 1 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Utah - Sugarhouse Clinic
Salt Lake City, Utah, 84112
Laurie Fajardo, MD, 801-581-2000, u0447662@umail.utah.edu
About this study
Official title: Acquisition and Clinical Image Evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images
Acquisition and clinical image evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) images.
Read the detailed description
This study is designed to acquire Fujifilm DBT HR mode images and following image acquisition, includes a Clinical Image Evaluation study to assess whether Fujifilm HR DBT images are of sufficiently acceptable quality for use in clinical mammography.
- Conditions
- Routine Screening Mammography
- Being tested
- DBT HR mode image acquisition
- Keywords
- Screening Mammogram, Mammogram, Digital Breast Tomosynthesis (DBT)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DBT HR mode image acquisitionDevice
Fujifilm DBT HR image acquisition.
| Study group | Role | What they receive |
|---|---|---|
| DBT HR mode acquisition with N-mode or H-mode dose | Experimental | All required imaging for one dose mode will be completed before switching to the other dose mode. Receives: Device: DBT HR mode image acquisition |
What is being measured
The primary outcome is the main question the study is designed to answer.
Image Acquisition
To acquire appropriate and sufficient cases to support the Clinical Image Evaluation part of the study.
Measured: Each study participant will attend a single study visit (acquisition).
Clinical Image Evaluation - Image quality
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.
Measured: Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day.
Secondary outcomes (2)
Image Acquisition - Safety evaluation
To further evaluate the safety of DBT HR mode imaging by analyzing frequency and characteristics of any adverse events.
Measured: Each study participant will attend a single study visit (acquisition).
Clinical Image Evaluation - Pass rating
To determine whether overall clinical image quality is acceptable, as assessed by expert mammographic radiologists. Study success requires all of the cases to receive a Pass rating.
Measured: Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start20 Jul 2026
- Primary completion15 Jan 2027 (estimated)
- Study completion1 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Routine Screening MammographyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Asymptomatic women who received a final BI-RADS Assessment Category of 1 or 2 on their routine screening mammogram will be invited and consented to have images obtained using DBT HR mode, with either N-mode or H-mode dose. These images will then be reviewed by expert radiologists where they will judge if the images are of sufficiently acceptable overall clinical image quality for use in clinical mammography.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- International HealthCare, LLC
- Responsible party
- Sponsor
- Investigators
- Laurie L. Fajardo, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07471750
- Sponsor's protocol ID
- FHCA2026-001
- Status last verified
- Oct 2026
- First submitted
- 10 Mar 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acquisition and Clinical Image Evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) Images
- ClinicalTrials.gov ID
- NCT07471750
- Acronym / sponsor ID
- FHCA2026-001
- Conditions
- Routine Screening Mammography
- Keywords
- Screening Mammogram, Mammogram, Digital Breast Tomosynthesis (DBT)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Fujifilm Medical Systems USA, Inc.Industry (pharma, biotech, devices)
- Collaborators
- International HealthCare, LLC
- Study start
- 20 Jul 2026 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 1 Mar 2027 (estimated)
- First posted
- 13 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Acquisition and clinical image evaluation of Fujifilm High Resolution (HR) Digital Breast Tomosynthesis (DBT) images.
Detailed description
This study is designed to acquire Fujifilm DBT HR mode images and following image acquisition, includes a Clinical Image Evaluation study to assess whether Fujifilm HR DBT images are of sufficiently acceptable quality for use in clinical mammography.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Asymptomatic women who received a final BI-RADS Assessment Category of 1 or 2 on their routine screening mammogram will be invited and consented to have images obtained using DBT HR mode, with either N-mode or H-mode dose. These images will then be reviewed by expert radiologists where they will judge if the images are of sufficiently acceptable overall clinical image quality for use in clinical mammography.
| Arm | Type | Receives |
|---|---|---|
| DBT HR mode acquisition with N-mode or H-mode dose | Experimental | Device: DBT HR mode image acquisitionAll required imaging for one dose mode will be completed before switching to the other dose mode. |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DBT HR mode image acquisitionFujifilm DBT HR image acquisition. | Device | DBT HR mode acquisition with N-mode or H-mode dose |
Primary outcome
Image Acquisition
Time frame: 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
Time frame: 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.
2 secondary outcomes
Image Acquisition - Safety evaluation
Time frame: Each study participant will attend a single study visit (acquisition).
Clinical Image Evaluation - Pass rating
Time frame: Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Routine Screening Mammography
RecruitingObservational study
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Active, not recruiting
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Breast Cancer Mortality
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Laurie L. Fajardo, MD principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DBT HR mode image acquisition in people with Routine Screening Mammography, run by Fujifilm Medical Systems USA, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nicole M. Calabrese, MS (518-506-9840, nicolec@ihcresearch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Image Acquisition (time frame: Each study participant will attend a single study visit (acquisition).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.