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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age40+
SponsorUniversity of Arizona

About this trial

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.

Eligibility criteria

Qualifiers

(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,

Disqualifiers

Males

Women less than 40 years old

pregnant or lactating women

women with physical limitations (e.g., kyphosis) that may prohibit UBCT exam

Trial design

Treatments tested in this trial

  • Low dose, upright, dedicated breast CT

Treatment groups

50 Participants
are divided into 2 treatment groups

Locations

This trial has no locations

Sponsors and collaborators

University of Arizona

Lead sponsor

National Cancer Institute (NCI)

Collaborator