Using Cone Beam Breast CT for Breast Cancer Screening
Cone Beam Breast CT for Breast Cancer Screening
This study is testing a new type of breast scan called Cone Beam Breast CT to see if it can improve breast cancer screening for women aged 30 and older.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 1024 (estimated) |
| Ages | 30 Years and up |
| Sex | Female |
| Sponsor | Koning Corporation Industry-sponsored |
| Drugs / interventions | radiation |
| Locations | 4 sites (Port Orange, Florida and 3 other locations) |
| Trial ID | NCT05036096 on ClinicalTrials.gov |
What this trial studies
This study aims to enroll up to 1,028 women aged 30 and above who are either scheduled for routine screening mammography or undergoing diagnostic workup for breast abnormalities. Participants will undergo a Cone Beam Breast CT (KBCT) scan within four weeks of their mammography exam to create an enriched dataset for evaluating the effectiveness of this imaging technique. The study focuses on enhancing breast cancer screening methods by comparing KBCT imaging results with standard mammography. The goal is to improve early detection and diagnosis of breast cancer.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 30 and above who are scheduled for routine or diagnostic mammography.
Not a fit: Patients who are pregnant, lactating, or have certain physical limitations that prevent them from participating will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved breast cancer screening methods, potentially allowing for earlier detection and better patient outcomes.
How similar studies have performed: While there is ongoing research in advanced imaging techniques for breast cancer, the specific use of Cone Beam Breast CT in this context is relatively novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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)
Where this trial is running
Port Orange, Florida and 3 other locations
- Port Orange Imaging Center — Port Orange, Florida, United States (Completed)
- Women's Imaging Specialists — Dacula, Georgia, United States (Completed)
- The Howard Center for Women's Health — Tifton, Georgia, United States (Recruiting)
- Knoxville Comprehensive Breast Center — Knoxville, Tennessee, United States (Completed)
Study contacts
- Study coordinator: Xiaohua Zhang, Ph.D.
- Email: xiaohua.zhang@koningcorporation.com
- Phone: 5852142459
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.