Randomized Controlled Trial of Optimization of Contrast Agent Dose in CT With Lean Body Weight
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 274
- 试验地点
- 1
- 主要终点
- Contrast Enhancement
研究概览
简要总结
This study evaluates the different enhancement using a contrast agent dose in computed tomography based on total body weight or based on lean body weight. Half of participants will receive contrast agent dose based on their total body weight, while the other half will receive a dose based on their lean body weight. Our hypothesis is that if contrast agent is administered not basing on total body weight but on lean body weight it is possible to obtain equal or better quality of enhanced images, a reduction of the variability of contrast enhancement, and also a dose reduction in some patients (overweight ones).
详细描述
Patients will undergo a CT scan of abdomen (multi-phasic) with contrast agent and will be measured: total body weight (TBW), height, lean body weight (LBW) and body mass index (BMI) through formulas known in literature and with a balance for bioelectrical impedance analysis. There is no administration of drugs other than those indicated in the request of the treating physician.
Contrast agent dose:
IOPAMIRO® (Iopamidol) is an x-ray contrast medium of the new generation of non-ionic compounds, which are watersoluble because the molecular structure incorporates hydrophilic groups. Recommended dosage (ml) is 0.5-2.0/kg. Single injection volume depends on the vascular area to be examined.
IOMERON® (Iomeprolo) is an x-ray contrast medium of the new generation of non-ionic compounds, which are watersoluble because the molecular structure incorporates hydrophilic groups. Recommended dosage (ml) is 0.5-2.0/kg. Single injection volume depends on the vascular area to be examined.
Patients will be randomly assigned to undergo one of the two contrast agent protocols.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
Patients will be assigned to the TBW or LBW group based on a randomization generated by a computer, the progressive sequences containing the randomization code will be perform by an outside operator to the experiment group. Only CT technician and nurse that will record patient's data and results from scale analysis will know and will register in which group the patients will be assigned.
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 ≥ 18 years of age;
- •Patients who will perform a contrast-enhanced abdominal CT multi-phasic in our institutions;
- •Patients able to give informed consent.
排除标准
- •history of chronic underlying liver disease (cirrhosis, fatty infiltration of the liver, or glycogen storage disease);
- •history of chronic underlying heart disease (congestive heart failure, prior cardiac valve replacement, restrictive and/or constrictive pericarditis);
- •multiple myeloma;
- •hypersensitivity to iodine-containing compounds;
- •renal insufficiency (serum creatinine level ≤ 1.8 mg/dL [159.12 µmol/L]) or patients with renal failure (eGR <30 ml/min/1.73 m2);
- •patients with antecubital vein that, at medical evaluation, cannot sustain the flow rate of CA injection (see below);
- •patients carrier of prosthesis or metal bullets, pacemaker or stimulators;
- •patients with liver diseases that affect the entire parenchyma;
- •fragile patients which, after radiologist evaluation, require lower dose of CA;
- •pregnancy;
- •general contraindications to CT examination or reasoned decision of the radiologist.
研究组 & 干预措施
TBW protocol
Patients will receive a contrast agent dose based on their TBW as a standard clinic protocol.
干预措施: Iopamidol (Drug)
LBW protocol
Patients will receive a contrast agent dose based on their calculated LBW.
干预措施: Iopamidol (Drug)
结局指标
主要结局
Contrast Enhancement
时间窗: 1 day
The liver contrast enhancement (ΔCEL) will be calculated as the difference between the CT value measured in the venous phase and that measured before contrast injection.
次要结局
未报告次要终点
研究者
Francesco Sardanelli
Head of Radiology
IRCCS Policlinico S. Donato