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

The investigators are doing this study 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 that will be used 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.

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Key information

Conditions

Breast Cancer Detection

Age range

40 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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,
(3) 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
women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as tuberculosis, and severe scoliosis.

Treatment and study plan

Low dose, upright, dedicated breast CT

Device

This study investigates the feasibility of an upright, dedicated breast CT (UBCT) for breast cancer detection.

Other names: UBCT

Primary outcomes

Feasibility of UBCT

Time frame: From enrollment to end of study in approximately 6 months.

The proportion of participants who successfully complete the imaging exam using upright, dedicated breast CT (UBCT).

Study contacts

Contact information is provided by the study sponsor or research team.

Michele N Galvan, R.T.

CONTACT

[email protected]

520-626-2279

Sponsors and collaborators

Lead sponsor

University of Arizona

Other

Collaborators

National Cancer Institute (NCI)

Registry information

Acronym: UBCT

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: Jul 15, 2026
Registry last updated: Jul 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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