Comparison of Imaging Quality Between Spectral Photon Counting Computed Tomography (SPCCT) and Dual Energy Computed Tomography (DECT)
试验速览
- 阶段
- 不适用
- 入组人数
- 339
- 试验地点
- 1
- 主要终点
- quality of the images
研究概览
简要总结
This pilot study wants to determine to which extent SPCCT allows obtaining images with improved quality and diagnostic confidence when compared to standard Dual Energy CT (DECT), both with and without contrast agent injection.
Depending on the anatomical structures/organs to be visualized during CT examinations, different scanning protocols are performed with quite variable ionizing radiation doses. Therefore, in order to obtain the most extensive and representative results of the improvement in image quality between SPCCT and DECT that will be performed CT imaging on several body regions and structures, including diabetic foot, diabetic calcium coronary scoring, adrenal glands, coronary arteries, lung parenchyma, kidney stones, inner ear, brain and joints, earl/temporal bone, colorectal carcinosis.
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
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
- •Patients presenting following one of following medical conditions:
- •Asymptomatic type 1 or 2 diabetes as regard to cardiovascular risks
- •Diabetic foot ulcer
- •Adrenal glands lesions: Adrenal incidentaloma or hyperaldosteronism or macroadenoma
- •Urinary stone(s)
- •Known Coronary artery disease: Stent imaging or control of calcified plaques
- •Diffuse Interstitial Lung Diseases: Idiopathic Pulmonary Fibrosis, Hypersensitivity Pneumonitis, Ground Glass Opacification, Chronic Thromboembolic Pulmonary Hypertension
- •Conductive hearing loss
- •Brain stroke (late or post thrombectomy)
- •Intracranial arteriovenous malformation treated with coils or Onyx
- •Joints diseases in haemophilia
- •Ear/temporal bone
- •Colorectal carcinosis
- •Dissection aortique de type A opérée ou de type B non opérée, hématome intramural
- •Patient has accepted to participate to the study and has signed the written consent;
- •Pre-menopausal women only: Negative urinary pregnancy test on the day of imaging before the administration of study drug;
- •Patient is affiliated to the French social security
排除标准
- •Contraindication to the use of iodine containing contrast media (including subjects with suspicion for/or known to have NSF) (if injection);
- •History of severe allergic or anaphylactic reaction to any allergen including drugs and contrast agents (as judged by the investigator, taking into account the intensity of the event);
- •History of delayed major or delayed cutaneous reaction to Iomeron injection
- •Estimated Glomerular Filtration Rate (eGFR) value < 30 mL/min/1.73 m2 derived from a serum creatinine result within 1 month before the imaging for examinations with contrast agent.
- •Any subject on hemodialysis or peritoneal dialysis;
- •Suspected clinical instability or unpredictability of the clinical course during the study period (e.g. due to previous surgery);
- •Pregnant or nursing (including pumping for storage and feeding);
- •Patient under guardianship, curatorship or safeguard of justice.
研究组 & 干预措施
SPCCT and standard DECT
Comparative intra-patients (each patient will have both types of scanner imaging done), clinical superiority study, evaluating the imaging performances (e.g. image quality and radiation dose) of SPCCT and standard DECT for several body regions/anatomical structures.
干预措施: Spectral Photon Counting Computed Tomography (SPCCT) (Device)
SPCCT and standard DECT
Comparative intra-patients (each patient will have both types of scanner imaging done), clinical superiority study, evaluating the imaging performances (e.g. image quality and radiation dose) of SPCCT and standard DECT for several body regions/anatomical structures.
干预措施: DECT (Dual Energy CT) (Device)
结局指标
主要结局
quality of the images
时间窗: Day 8
A single four-point scale will be used (1: unacceptable, 2: usable under limited conditions, 3: probably acceptable, 4: fully acceptable) based on the European guidelines on quality criteria for computed tomography
次要结局
- Dose Length Product (DLP)(Day 8)
- Equivalent dose (mSv)(Day 8)
- Subjective image quality graded(Day 8)
- Diagnostic confidence graded(Day 8)
- Quantitatively image quality : Noise(Day 8)
- Quantitatively image quality : contrast-to-noise ratio(Day 8)
- CT Dose Index volumic (CTDIvol)(Day 8)
- Radiation dose(Day 8)
- Quantitatively image quality : Density(Day 8)
- Depiction of anatomical structures of interest(Day 8)
- Statistical comparison between SPCCT and DECT(Day 8)