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

March 13, 2026 updated by: Fujifilm Medical Systems USA, Inc.

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DBT HR mode acquisition with N-mode or H-mode dose
All required imaging for one dose mode will be completed before switching to the other dose mode.
Device: DBT HR mode image acquisition
Fujifilm DBT HR image acquisition.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Each study participant will attend a single study visit (acquisition).
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.
Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Image Acquisition - Safety evaluation
Time Frame: Each study participant will attend a single study visit (acquisition).
To further evaluate the safety of DBT HR mode imaging by analyzing frequency and characteristics of any adverse events.
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.
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.
Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fujifilm Medical Systems USA, Inc.

Collaborators

International HealthCare, LLC

Investigators

  • Principal Investigator: Laurie L. Fajardo, MD, University of Utah

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 30, 2026

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

March 10, 2026

First Submitted That Met QC Criteria

March 10, 2026

First Posted (Actual)

March 13, 2026

Study Record Updates

Last Update Posted (Actual)

March 16, 2026

Last Update Submitted That Met QC Criteria

March 13, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHCA2026-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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