Cone Beam Breast CT for Breast Cancer Screening (NCT05036096)
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: To join this study, participants generally need to meet the listed inclusion criteria (8 items) and avoid the listed exclusions (18 items).
Location: Port Orange Imaging Center — Port Orange, Florida
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistCheck every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).
Usually NOT eligible if any of the following apply:
- 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
🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.
📍 All Participating Trial Locations (4 Sites)
- 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
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.