NCT03954431 · University of Arizona
High-Resolution Lower Dose Dedicated Breast Computed Tomography (CT)
(LowerDoseBCT)
What this study is about
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.
View original scientific description
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.
Interventions
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.
Primary outcome measures
Diagnostic accuracy
Time frame: 12 months after completion of accrual
The diagnostic accuracy of BCT will be determined from a multi-reader, multi-case reader study.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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:
- women less than 40 years old,
- women unable to self-consent,
- 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.
Where
- Tucson, Arizona
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 24, 2025 · Source of record for eligibility and locations