Low Tube Voltage Kidney Computed Tomography Using Low Concentration Iodine Contrast Agent: A Comparison Study With Conventional CT Protocol
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Quantitative analysis - Radiation dose
研究概览
简要总结
This prospective study aims to evaluate clinical usefulness of low-voltage renal CT using low-concentration contrast agent and to compare with existing imaging techniques.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects with no abnormalities in renal function (Serum creatinine < 1.4 mg/dl , GFR > 45mL/min/1.73 m2) in blood tests performed within one month
- •Those who understand the contents of the research subject explanation and voluntarily sign the consent form
排除标准
- •Body mass index > 30
- •Subjects whose renal function abnormality was confirmed in a blood test (Serum creatinine > 1.4 mg/dl , GFR < 45mL/min/1.73 m2) conducted within one month
- •Diabetic patients taking metformin
- •Those with a history of urinary tract obstruction
- •Those with a history of bladder, urinary tract, or kidney surgery that may affect the evaluation of the contrast agent in the renal parenchyma
- •Those whose anatomical deformities have been identified in previous images that may interfere with image analysis
- •Those who know or have been reported to have a history of contrast agent side effects in previous CT scans
- •Those with a history of hypersensitivity or adverse reactions to iobrix (intravascular CT contrast) or iodine based agent
- •Those with severe thyroid disease
- •Pregnancy
- •Those who are judged unsuitable for clinical trials by the researcher for reasons such as having other severe diseases or being judged to have a high risk of adverse reactions to intravascular contrast agents
结局指标
主要结局
Quantitative analysis - Radiation dose
时间窗: 6 months after the CT scan
Effective radiation dose (mSv) annotated on CT image
Quantitative analysis - Signal to noise ratio
时间窗: 6 months after the CT scan
Value calculated by ( mean attenuation / standard deviation of attenuation of contrast area)
Quantitative analysis - Contrast to noise ratio
时间窗: 6 months after the CT scan
Value calculated by \[ ( mean attenuation - attenuation of contrast area) / standard deviation of attenuation of contrast area \]
Qualitative analysis - Diagnostic acceptability, Noise , Artifacts , Sharpness
时间窗: 6 months after the CT scan
4 points scale quantitative analysis evaluated by three different radiologists
次要结局
- Diagnoses of focal lesion and inter-observer agreement(6 months after the CT scan)
研究者
June Young Seo
Clinical fellow
Seoul National University Hospital