Recruiting

Digital Breast Tomosynthesis

Sponsor:

Fujifilm Medical Systems USA, Inc.

Code:

NCT07471750

Conditions

Routine Screening Mammography

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Accepted

Interventions

DBT HR mode image acquisition

Study Details

Brief summary:

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

Conditions

Routine Screening Mammography

Study ID

NCT07471750

Start date

Jul 20, 2026

Status verified date

Oct, 2026

Completion date

Mar 1, 2027

Anticipated

Primary completion date

Jan 15, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

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).

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

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.

Interventions

DBT HR mode image acquisition

Fujifilm DBT HR image acquisition.

Primary outcome measure

  • Image Acquisition [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Nicole M. Calabrese, MS

518-506-9840nicolec@ihcresearch.com

Locations

University of Utah - Sugarhouse Clinic

Recruiting

Salt Lake City, Utah, United States, 84112

Contacts

Laurie Fajardo, MD

801-581-2000u0447662@umail.utah.edu

More Information

Sponsor

Fujifilm Medical Systems USA, Inc.

Last update posted

Oct 14, 2026

Last verified

Oct, 2026

Keywords

  • Screening Mammogram
  • Mammogram
  • Digital Breast Tomosynthesis (DBT)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-15. This information was provided to ClinicalTrials.gov by Fujifilm Medical Systems USA, Inc. on 2026-10-14. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.