Clinical trial · Interventional
Koning Breast CT for Breast Imaging in China
NCT01792999CI-TRIAL-00031960completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study is conducted to compare Koning Breast CT (KBCT) to mammography to evaluate if KBCT can improve the diagnostic accuracy of breast cancer. It will also compare contrast-enhanced KBCT (CE-KBCT) to mammography to evaluate if CE-KBCT can further improve the diagnostic accuracy of breast cancer.
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 | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Contrast-enhanced KBCT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Non-contrast KBCT
- description
- About 187 subjects, who had diagnostic imaging of the breast including mammography and were categorized as Breast Imaging-Reporting and Data System(BIRADS) scores 1, 2, 3, 4, or 5, received KBCT imaging without contrast injection.
- type
- EXPERIMENTAL
- label
- Contrast-enhanced KBCT
- description
- About 231 subjects, who had diagnostic imaging of the breast including mammography and were scheduled for biopsy or surgery, received contrast-enhanced KBCT imaging of the affected breast before biopsy or surgery.
- interventionNames
- Device: Contrast-enhanced KBCT
Primary outcomes (1)
- measure
- Efficacy of KBCT, CE-KBCT and Mammography
- timeFrame
- 1 year
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 35 Years
Show eligibility criteria text
Non-contrast KBCT Inclusion Criteria: * Females at least 35 years of age of any ethnicity * Had diagnostic imaging * Will undergo study imaging no later than two weeks from date of diagnostic mammogram * Is able to undergo informed consent 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 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 Hodgkins 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 Contrast-enhanced KBCT Inclusion Criteria: * Females at least 35 years of age of any ethnicity * Had diagnostic imaging and was determined to have biopsy or surgery * Will undergo study imaging no later than two weeks from date of diagnostic mammogram * Is able to undergo informed consent Exclusion Criteria: Same as the exclusion criteria as non-contrast KBCT, plus the following: * Abnormal Glomerular Filtration Rate (GFR)/Blood Urea Nitrogen (BUN) or Creatinine at Pre contrast blood screening * Previous non-ionic contrast reaction * History of renal dysfunction/kidney disease * Diabetes mellitus treated with metformin * Multiple myeloma * Dehydration * History of nephrotoxic medication use * Hyperthyroidism * Pheochromocytoma * Sickle Cell Disease
References
Publications (0)
Data not yet available
No reference posted for this study.