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

Not yet recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Dedicated breast CT(BCT)

• Registration Number: NCT03954431
• Lead Sponsor: University of Arizona

Brief 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.

Study Timeline

• Study First Submitted: 2019-05-15
• Study First Submitted QC: 2019-05-15
• Study First Posted: 2019-05-17
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-28
• Last Update Posted: 2025-03-30
• Study Start: 2025-04
• Primary Completion: 2028-12
• Study Completion: 2029-12

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dedicated breast computed tomography (BCT)	Dedicated breast CT(BCT)	All subjects will undergo bilateral breast CT (BCT) imaging exam.

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy	12 months after completion of accrual	The diagnostic accuracy of BCT will be determined from a multi-reader, multi-case reader study.

Trial Locations

Locations (1)

University of Arizona; 🇺🇸 Tucson, Arizona, United States