High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT) (LowerDoseBCT)

Study of High-resolution, Lower Dose Dedicated Breast CT.

This study is being performed to find out if a new kind of breast imaging (called dedicated breast CT or BCT) can help doctors to see the small structures in breast tissue more clearly. The investigators also want to find out if using the BCT will provide a more accurate diagnosis of breast cancer.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: Dedicated breast CT(BCT)

Detailed Description

The breast imaging device that will be used in this study (breast computed tomography or BCT) is not FDA-approved for this use so this is a research study. The machine has been redesigned to see if doctors can see smaller structures and use a lower radiation dose.

The breast CT device will take multiple pictures of the subject's breast and create a 3-D image of the breast. It does not compress or squash the breast like a mammogram.

• Study Type: Interventional
• Enrollment (Estimated): 600
• Phase: Not Applicable

Contacts and Locations

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

Study Locations

• United States
  • Arizona
    • Tucson, Arizona, United States, 85724
      • Recruiting
      • University of Arizona
      • Principal Investigator: Srinivasan Vedantham, PhD
      • Sub-Investigator: Alan J-T Chiang, MD, PhD
      • Contact: Michele Galvan, R.T.; Phone Number: 520-626-2279; Email: mngalvan@arizona.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Study Population

Women who present for breast cancer screening imaging exam, recalled after screening exam, and assigned to undergo tissue sampling (biopsy).

Description

Inclusion criteria: All subjects that are eligible to participate in the study will be women who satisfy all of the inclusion criteria stated below:

• who are 40 years of age or older (typical screening age range)
• who are undergoing or scheduled for screening or diagnostic imaging, or need a biopsy to investigate an abnormality in the breast.

Exclusion criteria: Subjects that present with any of the criteria listed below will be excluded:

• Males,
• women less than 40 years old,
• women unable to self-consent,
• prisoners,
• pregnant, suspected to be pregnant, or lactating women (self-reported)
• women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker;
• women who are unable to tolerate study constraints, frail, or unable to cooperate;
• women who weigh more than 440 lbs (200 Kg), which is the weight limit for the patient support table of the BCT system;
• women who have received radiation treatments to the thorax for malignant and nonmalignant conditions, such as (but not limited to) treatment for enlarged thymus gland as an infant, irradiation for benign breast conditions, including breast inflammation after giving birth, and treatment for Hodgkin's disease;
• women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram;
• women who have received large number of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) tuberculosis, and severe scoliosis.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dedicated breast computed tomography (BCT); All subjects will undergo bilateral breast CT (BCT) imaging exam.	Diagnostic test: Dedicated breast CT(BCT); The breast CT device will take multiple pictures of the subject's uncompressed breast and creates a 3-D image of the breast.; Other Names: BCT

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Diagnostic accuracy	The diagnostic accuracy of BCT will be determined from a multi-reader, multi-case reader study.	12 months after completion of accrual

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Contrast enhancement quantification	The amount of contrast enhancement with CE-BCT will be quantified.	18 months

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): August 14, 2025
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: May 15, 2019
• First Submitted That Met QC Criteria: May 15, 2019
• First Posted (Actual): May 17, 2019

Study Record Updates

• Last Update Posted (Actual): August 24, 2025
• Last Update Submitted That Met QC Criteria: August 18, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 1903399639; R01CA199044 (U.S. NIH Grant/Contract)

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