Koning Breast CT for Breast Imaging in China
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 418
- 试验地点
- 2
- 主要终点
- Efficacy of KBCT, CE-KBCT and Mammography
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Non-contrast KBCT
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
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.
干预措施: Contrast-enhanced KBCT (Device)
结局指标
主要结局
Efficacy of KBCT, CE-KBCT and Mammography
时间窗: 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.
次要结局
- Safety of KBCT, CE-KBCT and Mammography(1 year)