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

This study is looking at a new way to image the breast called dedicated breast CT (BCT). Doctors want to see if BCT can show small structures in breast tissue more clearly and provide a more accurate diagnosis of breast cancer compared to current methods. The BCT device takes multiple pictures of your uncompressed breast to create a 3-D image. This study is for women aged 40 or older who are having or scheduled for breast screening, diagnostic imaging, or need a biopsy. The goal is to measure how accurate BCT is in diagnosing breast cancer. The study aims to enroll 600 participants, but its current recruitment status is unclear.

Study design: This is an interventional study planning to enroll 600 women. It is not specified if it is randomized or blinded.
What's involved: You would undergo imaging with the dedicated breast CT (BCT) device, which takes multiple pictures of your uncompressed breast.
Compensation: Not stated in the trial record.
Follow-up: The diagnostic accuracy will be measured 12 months after all participants have completed their imaging.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

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

Recruiting

NAAges 40+InterventionalDiagnostic

University of Arizona

~600 participants

Updated 2025-08-24 on ClinicalTrials.gov

What's tested:Dedicated breast CT(BCT)

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Diagnostic accuracy

Measured over 12 months after completion of accrual

Conditions

Breast Cancer

Where it's being run

1 sites across 1 states

Arizona1

Study leadership

Srinivasan Vedantham, PhD · PRINCIPAL_INVESTIGATOR · University of Arizona

Who to contact

Michele Galvan, R.T.R.

[email protected]

520-626-2279

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

Diagnostic accuracy12 months after completion of accrual
The diagnostic accuracy of BCT will be determined from a multi-reader, multi-case reader study.

Trialytics