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Not yet recruiting NCT07471750

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

No phase Interventional Routine Screening Mammography

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: DBT HR mode image acquisition.
Who it may be relevant to
Registry conditions: Routine Screening Mammography. Basic parameters: from 40 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Device DBT HR mode image acquisition
    Fujifilm DBT HR image acquisition.

Primary outcome measures

  • 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.]
Secondary outcome measures (2)
  • 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.]

Eligibility criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Screening

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07471750 · FHCA2026-001

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗