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Clinical Trials in the USA / NCT05036096
Active, not recruiting Not applicable

Cone Beam Breast CT for Breast Cancer Screening

NCT05036096 · tracked via the Priya Life Science USA tracker
Sponsor
Koning Corporation
Phase
Not applicable
Started
2021-10-30
Last updated
2026-02-05

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

CBBCT ImagingDigital Mammography

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

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.

Study 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.

Eligibility

Sex
FEMALE
Min age
30 Years
Max age
Healthy volunteers
Accepted
Inclusion Criteria: Screening Group: * Female sex of any ethnicity * Age 40 years or older * Scheduled for a routine screening mammography exam within 4 weeks. Diagnostic Group: * Female sex of any ethnicity * Age 30 years or older * Have an abnormality detected by Breast Self Exam (BSE), or Clinical Breast Exam (CBE), or have an abnormality detected by an imaging modality. * Will undergo diagnostic mammography, prior to breast biopsy (if needed). Exclusion Criteria: * Pregnancy * Lactation * Unknown pregnancy status AND * has refused pregnancy testing and * has refused to sign a pregnancy test waiver * Women who are unable or unwilling to understand or to provide informed consent * Women with physical limitations that may prohibit resting prone on the exam table, such as, but not limited to: frozen shoulder, recent heart surgery, pace maker. * Women who are unable to tolerate study constraints. * Women who have received radiation treatments to the thorax or breast area for malignant and nonmalignant conditions, such as (but not limited to): * Treatment for enlarged thymus gland as an infant * Irradiation for benign breast conditions, including breast inflammation after giving birth * Treatment for Hodgkin's disease * Women who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram. * Women who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to): * Tuberculosis * Severe scoliosis Additional exclusion criteria due to machine limitations * Patient's body weight is over the limit of the scanner table (440 lbs. or 200kg)

Primary outcome measure(s)

Trial sites (4)

FacilityCityRegionStatus
Port Orange Imaging Center Port Orange Florida
Women's Imaging Specialists Dacula Georgia
The Howard Center for Women's Health Tifton Georgia
Knoxville Comprehensive Breast Center Knoxville Tennessee

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05036096 on ClinicalTrials.gov ↗ ← All trials in the USA