NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: University of Arizona
Conditions: Breast Cancer Detection
Interventions: Low dose, upright, dedicated breast CT
The investigators are doing this study to find out if a new kind of breast imaging (called upright dedicated breast CT or UBCT) can help doctors to see the small structures in breast tissue more clearly in 3-D and without overlap. The breast imaging device that will be used in this study (UBCT) is not FDA-approved, so this is a research study. The machine has been designed to remove mammography-like breast compression and use radiation dose comparable to mammography. The breast CT device will take multiple x-ray pictures of the subjects breast in approximately 20 seconds and create a 3-D image of the breast. It does not compress or squish the breast like a mammogram.
Sex: FEMALE
Age: 40 Years to —
Healthy volunteers: Yes
Study type: INTERVENTIONAL
Inclusion Criteria: For the screening cohort, the inclusion criteria are, women: * (1) who were 40 years of age or older (typical screening age range), and, * (2) who were asymptomatic, and, * (3) who underwent or scheduled to undergo a standard-of-care 2-view bilateral digital breast tomosynthesis screening exam. For the diagnostic cohort, the inclusion criteria are, women: * (1) who were 40 years of age or older, and, * (2) who underwent a standard-of-care 2-view bilateral digital breast tomosynthesis exam, and, * (3) who were assigned BI-RADS category 4 or 5 after diagnostic work-up and are scheduled for biopsy. Exclusion Criteria: * Males * Women less than 40 years old * pregnant or lactating women * women with physical limitations (e.g., kyphosis) that may prohibit UBCT exam * women who have received radiation treatments to the thorax * women who have participated in a prior breast clinical trial that gave additional radiation dose * women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as tuberculosis, and severe scoliosis.