Clinical Feasibility Study of Upright, Low-dose, High-resolution, 3D Breast CT (UBCT). (UBCT)

We are doing this study because we want to find out if a new kind of breast imaging (called upright dedicated breast CT or UBCT) can help doctors to see the small structures in breast tissue more clearly in 3-D and without overlap.

The breast imaging device we will use in this study (UBCT) is not FDA-approved, so this is a research study. The machine has been designed to remove mammography-like breast compression and use radiation dose comparable to mammography. The breast CT device will take multiple x-ray pictures of the subjects breast in approximately 20 seconds and create a 3-D image of the breast. It does not compress or squish the breast like a mammogram.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer Detection
• Intervention / Treatment: Device: Low dose, upright, dedicated breast CT

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michele N Galvan, R.T.; Phone Number: 520-626-2279; Email: mngalvan@arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• For the screening cohort, the inclusion criteria are, women: (1) who were 40 years of age or older (typical screening age range), and, (2) who were asymptomatic, and, (2) who underwent or scheduled to undergo a standard-of-care 2-view bilateral digital breast tomosynthesis screening exam.

For the diagnostic cohort, the inclusion criteria are, women: (1) who were 40 years of age or older, and, (2) who underwent a standard-of-care 2-view bilateral digital breast tomosynthesis exam, and, (3) who were assigned BI-RADS category 4 or 5 after diagnostic work-up and are scheduled for biopsy.

Exclusion Criteria:

• Males; women less than 40 years old; pregnant or lactating women; women with physical limitations (e.g., kyphosis) that may prohibit UBCT exam; women who have received radiation treatments to the thorax; women who have participated in a prior breast clinical trial that gave additional radiation dose; and, women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as tuberculosis, and severe scoliosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Screening cohort; Women who undergo breast cancer screening using mammography and/or digital breast tomosynthesis.	Device: Low dose, upright, dedicated breast CT; This study investigates the feasibility of an upright, dedicated breast CT (UBCT) for breast cancer detection.; Other Names: UBCT
Experimental: Diagnostic cohort; Women who have suspicious finding(s) that require biopsy.	Device: Low dose, upright, dedicated breast CT; This study investigates the feasibility of an upright, dedicated breast CT (UBCT) for breast cancer detection.; Other Names: UBCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of UBCT	The ability to successfully complete the imaging exam using upright, dedicated breast CT (UBCT).	From enrollment to end of study in approximately 6 months.

Collaborators and Investigators

• Sponsor: University of Arizona
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Srinivasan Vedantham, PhD, University of Arizona

Study record dates

Study Major Dates

• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: July 10, 2026
• First Submitted That Met QC Criteria: July 10, 2026
• First Posted (Actual): July 15, 2026

Study Record Updates

• Last Update Posted (Actual): July 15, 2026
• Last Update Submitted That Met QC Criteria: July 10, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: 1904498647; R01CA241709 (U.S. NIH Grant/Contract); IRG 18-161-40 (Other Grant/Funding Number: American Cancer Society)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: IPD information may be shared with individual academic investigators in accordance with the University of Arizona's data sharing agreement.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes