Breast Cancer
Conditions
Keywords
Breast CT
Brief summary
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.
Interventions
DEVICEContrast-enhanced KBCT
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.
Sponsors
Koning (Tianjin) Medical Equipment Co., Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
35 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy of KBCT, CE-KBCT and Mammography | 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety of KBCT, CE-KBCT and Mammography | 1 year | 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. |
Countries
China
Outcome results
None listed