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NCT07705100
Clinical Feasibility Study of Upright, Low-dose, High-resolution, 3D Breast CT (UBCT).
Conditions: Breast Cancer Detection
Sex: Female
Ages: 40 Years – N/A
Healthy volunteers: Yes
Phase: NA
Enrollment: 50
Sponsor: University of Arizona
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07705100). StuddyBuddy aggregates publicly available trial information.