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

NCT07705100 | Not Yet Recruiting DMC FDA Device

• 3 other identifiers: 1904498647R01CA241709IRG 18-161-40
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer Detection

Outcome Measures

Primary Outcomes (1)

• Feasibility of UBCT

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

  From enrollment to end of study in approximately 6 months.

Study Arms (2)

Screening cohort

EXPERIMENTAL

Women who undergo breast cancer screening using mammography and/or digital breast tomosynthesis.

Device: Low dose, upright, dedicated breast CT

Diagnostic cohort

EXPERIMENTAL

Women who have suspicious finding(s) that require biopsy.

Device: Low dose, upright, dedicated breast CT

Interventions

Low dose, upright, dedicated breast CT DEVICE

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

Also known as: UBCT

Diagnostic cohort; Screening cohort

Eligibility Criteria

• Age: 40 Years+
• Gender Eligibility Details: Only women, aged 40 years or older, who are eligible for mammography screening are eligible to participate.
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• (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.
• (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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Arizona: lead
• National Cancer Institute (NCI): collaborator

Study Officials

• Srinivasan Vedantham, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Michele N Galvan, R.T.

CONTACT

520-626-2279; mngalvan@arizona.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2026
• First Posted: July 15, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 27, 2026

Record last verified: 2026-07