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

NCT ID: NCT03954431

Last Updated: 2025-08-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 600 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-14
• Study Completion Date: 2029-12-31

Brief Summary

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.

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Dedicated breast computed tomography (BCT)

All subjects will undergo bilateral breast CT (BCT) imaging exam.

Group Type: EXPERIMENTAL

Dedicated breast CT(BCT)

Intervention Type: DIAGNOSTIC_TEST

The breast CT device will take multiple pictures of the subject's uncompressed breast and creates a 3-D image of the breast.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

BCT

Eligibility Criteria

Inclusion Criteria

• 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

• 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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

National Institutes of Health (NIH)

NIH

Sponsor Role: collaborator

University of Arizona

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Srinivasan Vedantham, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Arizona

Locations

University of Arizona

Tucson, Arizona, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Michele Galvan, R.T.R.

Role: CONTACT

mngalvan@arizona.edu

520-626-2279

Facility Contacts

Michele Galvan, R.T.

Role: primary

mngalvan@arizona.edu

520-626-2279

Other Identifiers

R01CA199044

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1903399639

Identifier Type: -

Identifier Source: org_study_id