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

N/ANot Yet RecruitingNCT07471750

Fujifilm Medical Systems USA, Inc.18 enrolled

Overview

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

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

Allocation

Purpose

SCREENING

Masking

NONE

Enrollment

Conditions

Routine Screening Mammography

Interventions

DBT HR mode image acquisitionDEVICE

Fujifilm DBT HR image acquisition.

Eligibility

Sex: FEMALEMin age: 40 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Outcomes

Primary Outcomes

Image Acquisition

To acquire appropriate and sufficient cases to support the Clinical Image Evaluation part of the study.

Time frame: 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.

Time frame: Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day.

Secondary Outcomes

Image Acquisition - Safety evaluation

To further evaluate the safety of DBT HR mode imaging by analyzing frequency and characteristics of any adverse events.

Time frame: 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.

Time frame: Each reader's clinical image evaluations are anticipated to be completed in less than one (1) day.

Central Contacts

Nicole M. Calabrese, MS

CONTACT

518-506-9840 nicolec@ihcresearch.com

Data from ClinicalTrials.gov

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