NCT07471750

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 18 (estimated)
• Sponsor: Fujifilm Medical Systems USA, Inc. · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

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.

Conditions

• Routine Screening Mammography

Interventions

Type	Name	Description
DEVICE	DBT HR mode image acquisition	Fujifilm DBT HR image acquisition.

Timeline

• Start date: 2026-03-30
• Primary completion: 2026-05-15
• Completion: 2026-06-01
• First posted: 2026-03-13
• Last updated: 2026-03-16

Regulatory

• FDA-regulated device study