NCT00972413已完成1 期
Cone Beam Computed Tomography for Breast Imaging and IV Contrast Enhanced Cone Beam Computed Tomography Breast Imaging
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 104
- 试验地点
- 2
- 主要终点
- The study's intent is to provide compelling data to illustrate the potential contribution of CBCT for breast imaging, not to generate statistically significant data.
研究概览
简要总结
The primary aim of this study is to investigate the use of cone beam computed tomography (CBCT) for breast imaging in the diagnostic setting by providing a compelling body of evidence incorporating both non-contrast and contrast enhanced CBCT in the study protocol. The goal is to accumulate a body of evidence to provide data to incorporate CBCT into the diagnostic work-up of breast lesions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Are at least 40 years of age of any ethnicity
- •Had a mammogram, read as BI-RADS® 1 or 2
- •Will undergo study imaging no later than four weeks from date of mammogram.
- •Is able to undergo informed consent.
- •Are at least 40 years of age of any ethnicity
- •Had a routine mammogram, read as BI-RADS® 4 or 5
- •Are scheduled for breast biopsy
- •Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
- •Is able to undergo informed consent.
- •Are at least 40 years of age of any ethnicity
- •Had a routine mammogram, read as BI-RADS® 4 or 5
- •Are scheduled for breast biopsy
- •Will undergo study imaging no later than four weeks from date of mammogram, prior to breast biopsy.
- •Is able to undergo informed consent.
排除标准
- •Group I and Group II:
- •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
- •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
- •Allergy or previous reaction to iodinated contrast material
- •History of renal dysfunction/kidney disease
- •Long standing diabetes mellitus
- •Multiple myeloma
- •Dehydration
- •History of nephrotoxic medication use
- •Hyperthyroidism
- •Diabetic patients on Metformin
- •Pheochromocytoma
- •Sickle Cell Disease
结局指标
主要结局
The study's intent is to provide compelling data to illustrate the potential contribution of CBCT for breast imaging, not to generate statistically significant data.
时间窗: 3 years
次要结局
未报告次要终点
研究者
研究点 (2)
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