Clinical trial · Observational
Reader Study for Image Quality of Cone Beam Breast CT System
- 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)
Koning Breast CT (KBCT) was approved by FDA PMA. The X-ray detector originally used in Koning Breast CT was PaxScan 4030CB. Recently, Koning Breast CT uses a modified X-ray detector PaxScan 4030MCT. The modified detector is essentially identical to the previous model except a different detector housing which allows a narrower dead-space between the active area and the top of the housing. The benefit of the modified detector is that it allows Koning to modify the patient exam table, achieving a flatter surface in the center. The flatter surface will increase patient comfort and improve workflow. Meanwhile, flatter surface may also affect patient positioning and the coverage of the breast. The adequacy of the overall image quality with the new table/detector should be verified by radiologists.
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 Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rejection Rate
- timeFrame
- One hour training session followed by a one hour reading session
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Inclusion Criteria: * Females at least 35 years of age of any ethnicity * Had a mammogram, read as BIRADS 1 or 2 (group I) or BIRADS 4 or 5 (group II) * Will undergo study imaging no later than four weeks from date of mammogram * Is able to undergo informed consent * Require diagnostic imaging Exclusion Criteria: * Pregnancy * Lactation * Subjects 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 * Subjects who are unable to tolerate study constraints * Subjects who are unable to tolerate study constraints * Subjects who have received radiation treatments to the thorax 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 * Subjects who have participated in a prior breast clinical trial that gave additional radiation dose, such as an additional mammogram * Subjects who have received large numbers of diagnostic x-ray examinations for monitoring of disease such as (but not limited to) Tuberculosis Severe scoliosis
References
Publications (0)
Data not yet available