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Not Yet Recruiting 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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07705100). StuddyBuddy aggregates publicly available trial information.