Recruiting

BCT

Sponsor:

University of Arizona

Code:

NCT03954431

Conditions

Breast Cancer

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Accepted

Interventions

Dedicated breast CT(BCT)

Study Details

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.

Conditions

Breast Cancer

Study ID

NCT03954431

Start date

Aug 14, 2025

Status verified date

Aug, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 40+

Healthy Volunteers: Accepted

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 Design

Enrollment

600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Dedicated breast computed tomography (BCT)

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

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.

Primary outcome measure

  • Diagnostic accuracy [ Time Frame: 12 months after completion of accrual ]

Central Contacts and Locations

Central contacts

Michele Galvan, R.T.R.

520-626-2279mngalvan@arizona.edu

Locations

University of Arizona

Recruiting

Tucson, Arizona, United States, 85724

Contacts

Michele Galvan, R.T.

520-626-2279mngalvan@arizona.edu

Principal Investigator:

Srinivasan Vedantham, PhD

More Information

Sponsor

University of Arizona

Last update posted

Aug 24, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Arizona on 2025-08-24.