NCT03954431

High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT)

Study of High-resolution, Lower Dose Dedicated Breast CT.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 600 (estimated)
• Sponsor: University of Arizona · Academic / Other
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Accepted

Summary

This study is being performed to find out if a new kind of breast imaging (called dedicated breast CT or BCT) can help doctors to see the small structures in breast tissue more clearly. The investigators also want to find out if using the BCT will provide a more accurate diagnosis of breast cancer.

Detailed description

The breast imaging device that will be used in this study (breast computed tomography or BCT) is not FDA-approved for this use so this is a research study. The machine has been redesigned to see if doctors can see smaller structures and use a lower radiation dose. The breast CT device will take multiple pictures of the subject's breast and create a 3-D image of the breast. It does not compress or squash the breast like a mammogram.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Dedicated breast CT(BCT)	The breast CT device will take multiple pictures of the subject's uncompressed breast and creates a 3-D image of the breast.

Timeline

• Start date: 2025-08-14
• Primary completion: 2028-12-01
• Completion: 2029-12-01
• First posted: 2019-05-17
• Last updated: 2025-08-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study