Concordance of Image Quality Between an Ultra-Low Dose (ULD) Scanner and Standard Dose Conventional Scanner for Thoraco-abdominopelvic Scans
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 1
- 主要终点
- Concordance of the global quality of thoraco-abdomino-pelvic images from an Ultra-Low-Dose scanner acquisition compared to a standard dose scanner acquisition
研究概览
简要总结
The new image reconstruction algorithm (Precise Image, Philips Healthcare) has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (ULD) chest and abdomen-pelvis scans.
The hypothesis is that the images obtained with the Precise Image algorithm for ULD acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions.
详细描述
Recently a new image reconstruction algorithm based on Deep-learning has been developed (Precise Image, Philips Healthcare). Initial studies on phantoms have shown that this algorithm improves image quality and reduces patient dose compared to the iDose4 iterative reconstruction algorithm. Feasibility studies have validated the image quality for low-dose levels (LD). However, this algorithm has a strong potential to maintain sufficient image quality suitable for diagnosis with ultra-low dose (ULD) chest and abdomen-pelvis scans.
The hypothesis is that the images obtained with the Precise Image algorithm for ULD acquisitions are of sufficient and suitable quality for the diagnosis of certain lung, abdominal-pelvic and bone lesions.
The purpose of this study is to evaluate the concordance of the global quality of thoraco-abdominopelvic images of a ULD scan acquisition compared to a standard dose CT acquisition and measure the global agreement of the global quality of the images with a 4-point Likert scale.
The ULD acquisition will allow a significant reduction in the X-ray dose delivered to patients compared to a standard dose conventional scanner. This reduction is estimated at 70%.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
盲法说明
The reading of the images from the ULD scanner acquisition will be performed blinded to the patient's clinical record, the diagnosis made by the radiologist in charge of the patient on the basis of the standard dose conventional scanner, the result of the reading of the standard dose conventional scanner study and the reading of the other evaluator.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient having given free and informed consent.
- •Patient who has signed the consent form.
- •Patient affiliated to or beneficiary of a health insurance plan.
- •Patient with a BMI < 35 kg/m2
排除标准
- •Patient participating in research involving human subjects defined as Category
- •Patient in an exclusion period as determined by another study.
- •Patient under court protection, guardianship or trusteeship.
- •Patient unable to give consent.
- •Patient for whom it is impossible to give informed information.
- •Pregnant patient.
- •Patient with a BMI ≥ 35 kg/m2
研究组 & 干预措施
Patients undergoing Ultra-Low-Dose scan plus conventional standard dose thoraco-abdominopelvic scan
All adult patients (except pregnant women) presenting to the imaging department of the Institut de Cancérologie du Gard for a thoraco-abdominopelvic scan as part of an oncology follow-up will under a standard-dose can as well as an ultra-low-dose scan.
干预措施: Ultra-Low-Dose thoraco-abdominopelvic scan (Radiation)
结局指标
主要结局
Concordance of the global quality of thoraco-abdomino-pelvic images from an Ultra-Low-Dose scanner acquisition compared to a standard dose scanner acquisition
时间窗: Day 0
A 4-point Likert scale will be used to evaluate the overall image quality to see whether it is good enough to visualize the structures of interest and possible lesions. Overall image quality is rated as follows: 1. Completely interpretable without noise, smoothing, and/or artifact, 2. Completely interpretable with low artifacts and/or low level of noise or/and smoothing, 3. Interpretable with moderate noise and/or smoothing and moderate artifacts, 4. Uninterpretable
次要结局
- Frequency of good quality images with the Ultra-Low-Dose scanner(Day 0)
- Confidence level of each radiologist's diagnosis : Ultra-Low-Dose scan acquisition(Day 0)
- Frequency of good quality images with the standard dose scanner(Day 0)
- Overall concordance of the diagnosis. Pelvic bone lesions seen on the Ultra-Low-Dose scan(Day 0)
- Overall concordance of the diagnosis. Pelvic bone lesions seen on the Standard-Dose scan(Day 0)
- Overall concordance of the diagnosis. Thoracic lesions seen on the Ultra-Low-Dose scan(Day 0)
- Overall concordance of the diagnosis. Pelvic lesions seen on the Ultra-Low-Dose scan(Day 0)
- Overall concordance of the diagnosis. Pelvic lesions seen on the Standard-Dose scan(Day 0)
- Confidence level of each radiologist's diagnosis : Standard-Dose scan acquisition(Day 0)
- Inter-rater agreement (Senior vs. junior radiologist) regarding the Standard-Dose scan acquisitions(Day 0)
- Overall concordance of the diagnosis. Abdominal lesions seen on the Ultra-Low-Dose scan(Day 0)
- Overall concordance of the diagnosis. Abdominal lesions seen on the Standard-Dose scan(Day 0)
- Inter-rater agreement (Senior vs. junior radiologist) regarding the Ultra-Low-Dose scan acquisitions(Day 0)
- Overall concordance of the diagnosis. Thoracic lesions seen on the Standard-Dose scan(Day 0)
- Overall concordance of the diagnosis. Spine lesions seen on the Ultra-Low-Dose scan(Day 0)
- Overall concordance of the diagnosis. Spine lesions seen on the Standard-Dose scan(Day 0)
- Distribution of image quality with the Ultra-Low-Dose scanner(Day 0)
- Distribution of image quality with the standard dose scanner(Day 0)