Breast Cancer Detection
Conditions
Brief summary
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.
Interventions
DEVICELow dose, upright, dedicated breast CT
This study investigates the feasibility of an upright, dedicated breast CT (UBCT) for breast cancer detection.
Sponsors
University of Arizona
National Cancer Institute (NCI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility of UBCT | From enrollment to end of study in approximately 6 months. | The proportion of participants who successfully complete the imaging exam using upright, dedicated breast CT (UBCT). |
Contacts
CONTACTMichele N Galvan, R.T.
PRINCIPAL_INVESTIGATORSrinivasan Vedantham, PhD
University of Arizona
Outcome results
None listed