Clinical trial · Interventional
Clinical Feasibility Study of Upright, Low-dose, High-resolution, 3D Breast CT (UBCT).
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Detection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Low dose, upright, dedicated breast CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Screening cohort
- description
- Women who undergo breast cancer screening using mammography and/or digital breast tomosynthesis.
- interventionNames
- Device: Low dose, upright, dedicated breast CT
- type
- EXPERIMENTAL
- label
- Diagnostic cohort
- description
- Women who have suspicious finding(s) that require biopsy.
- interventionNames
- Device: Low dose, upright, dedicated breast CT
Primary outcomes (1)
- measure
- Feasibility of UBCT
- timeFrame
- From enrollment to end of study in approximately 6 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available