Koning Breast CT for Breast Imaging in China

Study Overview
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Brief Summary
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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.

Official Title
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Koning Breast CT for Breast Imaging in China

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Contrast-enhanced KBCT


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Non-contrast KBCT<br>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. | |
| Experimental: Contrast-enhanced KBCT<br>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. | Device: Contrast-enhanced KBCT<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast CT