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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-contrast KBCT | No Intervention | 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. | |
| Contrast-enhanced KBCT | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-enhanced KBCT | Device | Contrast-enhanced KBCT includes pre-contrast KBCT scan and post-contrast KBCT scan. After the pre contrast scan is completed, a bolus injection of a low osmolar, nonionic, iodinated 300mg of iodine per mL contrast agent, will be injected at a rate of approximately 2.0 mL/s, for a total injection time of approximately 30-60 seconds. 30-60 seconds after the contrast injection, the post-contrast scan will be acquired. |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy of KBCT, CE-KBCT and Mammography | Efficacy of KBCT, CE-KBCT and Mammography will be assessed based on the sensitivity for detecting breast cancer and the specificity for correctly categorizing non-cancer. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Safety of KBCT, CE-KBCT and Mammography | All enrolled and scanned patients will be included in the safety analysis. Anticipated and unanticipated adverse events will be tabulated according to severity and relation to device. | 1 year |
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Non-contrast KBCT
Inclusion Criteria:
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)
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)
Contrast-enhanced KBCT
Inclusion Criteria:
Exclusion Criteria:
Same as the exclusion criteria as non-contrast KBCT, plus the following:
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| Name | Affiliation | Role |
|---|---|---|
| Zhaoxiang Ye, MD, PhD | Tianjin Medical University Cancer Institute and Hospital | Principal Investigator |
| Peihong Wu, MD | Sun Yat-Sen University Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-Sen University Cancer Center | Guangzhou | Guangdong | 510060 | China | ||
| Tianjin Medical University Cancer Institute and Hospital |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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|
| Tianjin |
| Tianjin Municipality |
| 300060 |
| China |
| D017437 |
| Skin and Connective Tissue Diseases |