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

This trial accepts healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Low dose, upright, dedicated breast CT

    Device

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

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Screening cohortExperimental treatment 1 intervention
Group B: Diagnostic cohortExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Feasibility of UBCT

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

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

Secondary outcomes

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Arizona

Lead sponsor

National Cancer Institute (NCI)

Collaborator

This trial is not recruiting at the moment. You can still explore other options: