NCT07759011尚未招募不适用
Prospective, Single-Center Evaluation of Image Quality for Low-Dose Scans With Spectral Precise Image (SPI) Intelligent Denoising Versus iDose4 Reconstructions for Low- and Standard-Dose Scans - Clinical Study Protocol
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The rate of good-excellent scores ≥3
研究概览
简要总结
This study will prospective enroll 80 subjects to evaluate the comparison of image quality, proportion of high-quality images, and image noise between the Spectral Precise Image (SPI) intelligent denoising for low-dose scans on the Spectral CT Verida system and iDose4 reconstructions after low-dose and routine-dose scans.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 ≤ age ≤ 75 years.
- •18 kg/m² ≤ BMI ≤ 28 kg/m².
- •Conscious, able to cooperate, and competent to perform study procedures. Voluntarily agrees to participate in this clinical study and has signed the informed consent form.
- •Women of childbearing potential must have a negative pregnancy test and have no plans to become pregnant during the next 6 months.
排除标准
- •Persons without full civil capacity.
- •Pregnant or breastfeeding women.
- •Any other conditions that, in the investigator's judgment, make the subject unsuitable for participation in this clinical study.
研究组 & 干预措施
Normal Dose
Other
干预措施: CT Radiation Scan (Radiation)
Low dose
Experimental
干预措施: CT Radiation Scan (Radiation)
结局指标
主要结局
The rate of good-excellent scores ≥3
时间窗: From date of image reconstruction until the date of image reading completion, anticipated 1Week.
Image quality will be assessed by 2 radiologists using Likert-scale on a range from 1(poor) to 5(Excellent),and calculate the rate of ≥3 with FAS,PSS SS as the datasets analysis.
次要结局
- Objective outcome:Image Noise(From Image reconstruction to image noise recording finished，estimate 1Week.)
研究者
研究点 (1)
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