Chest CT Using Low-concentration Iodine Contrast Media - a Prospective Multicenter Comparative Study
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 370
- 试验地点
- 6
- 主要终点
- Anatomic depiction (including image sharpness)
研究概览
简要总结
This study aims to evaluate the quality of images when low-concentration iodine contrast agents is used in chest CT with low tube voltage and if they can be used in routine imaging.
The primary endpoint of the study was the quality of the image and comparison of chest CT by using low and conventional concentration iodine contrast agents with low tube voltage and chest CT by using the conventional concentration iodine contrast agents with the conventional tube voltage; The secondary endpoint is optimizing chest CT protocol using an iodine contrast agent.
详细描述
With persistent advances in computed tomography (CT) technology, there is a need for continuous investigation and optimization of injection protocols. Intravenous contrast enhancement in CT is affected by various interacting factors, which can be roughly divided into 3 categories: patient, contrast medium and CT scanning. Over the last decade, evolutions in technology has resulted in faster CTs with improved temporal and spatial resolutions; newer techniques such as iterative reconstruction has enabled lower tube voltage (expressed in units of peak kiloVolt, kVp) and lower dose CTs with less noise and preserved image quality. As CT scanning is one of the major determinants of contrast enhancement at CT, such technological advances in CT can be assumed to have invariably caused alterations in the degree of contrast enhancement at CT. However, despite changes in CT scanning techniques, recommended contrast injection protocol for chest CT with enhancement (CECT), including concentration of iodine contrast material, have not changed over the last decade; for routine chest CECT, the use of 300-350 mgI/ml iodine contrast material has been recommended without definitely stating the precise reasons using that specific iodine concentration.
Therefore, the aim of this study was to evaluate the image quality of low voltage chest CECT using LCCM(Low-Concentration Iodinated Contrast Media.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 19 years or older, weighing less than 90 kg, and BMI less than 30 who underwent contrast-enhanced chest CT alone
排除标准
- •Under the age of 18
- •Cases where contrast-enhanced CT cannot be performed
- •Heart failure
- •If patients cannot voluntarily give written consent to participate in this clinical trial
- •In the case of an anatomical deformation that may interfere with image analysis in the previous image
- •Patients with a history of hypersensitivity to IOBRIX, components of IOBRIX, and iodine-based drugs
- •Patients with severe thyroid disease (Iodine may accumulate in the thyroid gland and worsen symptoms.)
- •Those who are judged unsuitable by the tester for other reasons Patients aged 19 years or older, weighing less than 90 kg, and BMI less than 30 who underwent contrast-enhanced chest CT alone
研究组 & 干预措施
Chest CT evaluation (Administrate contrast media for CECT)
Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the conventional tube voltage
干预措施: Iohexol (320mgI/mL) with 120kVp (Drug)
Chest CT evaluation (Experimental 1)
Patients who are planned chest contrast enhanced CT scan ; Conventional concentration iodine contrast agents with the low tube voltage
干预措施: Iohexol (320mgI/mL) with 100kVp (Drug)
Chest CT evaluation (Experimental 2)
Patients who are planned chest contrast enhanced CT scan ; Low concentration iodine contrast agents with the low tube voltage)
干预措施: Iohexol (270mgI/mL) with 100kVp (Drug)
Chest CT evaluation (Experimental 3)
Patients who are planned chest contrast enhanced CT scan; Ultra Low concentration iodine contrast agents with the low tube voltage)
干预措施: Iohexol (240mgI/mL) with 100kVp (Drug)
结局指标
主要结局
Anatomic depiction (including image sharpness)
时间窗: 12 months after the CT scan (Chest contrast-enhanced CT is a 1-day procedure, but evaluating all the images will be done one year after the 1st CT scan.)
3 points scale qualitative analysis evaluated by two different radiologists (Poor, moderate, excellent)
Noise
时间窗: 12 months after the CT scan
3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)
Overall diagnostic acceptability
时间窗: 12 months after the CT scan
5 points scale qualitative analysis evaluated by two different radiologists (Non-diagnostic, suboptimal, standard, better than standard, Excellent)
Contrast-related artifact
时间窗: 12 months after the CT scan
3 points scale qualitative analysis evaluated by two different radiologists (Severe, minor, negligible)
次要结局
未报告次要终点
研究者
Jung Im Jung
Professor
Seoul St. Mary's Hospital