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ACTIVE NOT RECRUITING
NCT05036096
NA

Cone Beam Breast CT for Breast Cancer Screening

Sponsor: Koning Corporation

View on ClinicalTrials.gov

Summary

Up to one thousand and twenty-eight (1028) patients from screening and diagnostic population will be enrolled and consented to participate in the study to create an enriched data set. These women will be enrolled from annual screening population and diagnostic workup population. The enrolled patient will undergo KBCT scans within 4 weeks of her screening or diagnostic mammography exam and before breast biopsy occurs if biopsy is needed.

Key Details

Gender

FEMALE

Age Range

30 Years - Any

Study Type

INTERVENTIONAL

Enrollment

1024

Start Date

2021-10-30

Completion Date

2026-12-30

Last Updated

2026-02-05

Healthy Volunteers

Yes

Conditions

Interventions

DEVICE

CBBCT Imaging

Both breasts will be scanned by CBBCT. Only one breast will be scanned if the patient had mastectomy.

DEVICE

Digital Mammography

Both breasts will take digital mammography standard views (CC, MLO) Only one breast will take digital mammography standard views if the patient had mastectomy.

Locations (4)

Port Orange Imaging Center

Port Orange, Florida, United States

Women's Imaging Specialists

Dacula, Georgia, United States

The Howard Center for Women's Health

Tifton, Georgia, United States

Knoxville Comprehensive Breast Center

Knoxville, Tennessee, United States