The Relationship Between COntrast Media Volume and Tube voLtage in Computed Tomography of the Liver, for Optimal Enhancement Based on Total Body Weight: A Randomized Controlled Trial. [COMpLEx Trial]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 试验地点
- 2
- 主要终点
- A liver attenuation (Δ HU)
研究概览
简要总结
Computed Tomography (CT) is widely used in abdominal imaging for a variety of indications. Contrast media (CM) is used to enhance vascular structures and organ parenchyma. Attenuation of the liver makes it possible to recognize hypo- and hypervascular lesions, which are often invisible on unenhanced CT images. Lesions can only be detected in case they are large enough and the contrast with the background is high enough. Heiken et al. showed already in 1995 that a difference in Hounsfield Units (HU) of at least 50 HU is needed to be able to recognize liver lesions [1]. On the other hand, patients should not receive more CM than necessarily, because of possible underlying physiological effects [2-4]. Although there has been some controversy about this recently, there is no need to give patients more CM than needed, because of increased costs, no quality improvement and their might still be a relationship with contrast induced nephropathy (CIN) [5].
Recent publications suggested individualization of injection protocols that can be based on either total body weight (TBW) or lean body weight (LBW) [6-9]. In the investigators department an injection protocol based on TBW is currently used.
Besides the CM injection parameters, scanner parameters are of influence on the attenuation as well. Because of recent technical developments it became possible to reach a good image quality (IQ) at lower tube voltages [10]. When the x-ray output comes closer to the 33 keV k-edge of Iodine, attenuation increases. In short, decreasing the tube voltage increases the attenuation of iodine. Scanning at a lower tube voltage therefore gives rise to even lower CM volumes. Lastly, it would be revolutionary to accomplish a liver enhancement that is homogenous, sufficient for lesion detection and comparable between patients and in the same patients, regardless of weight and scanner settings used.
详细描述
Computed Tomography (CT) is a non-invasive imaging tool, used for a great variety of indications. Contrast media (CM) is used to enhance vascular structures and organ parenchyma. The visibility of liver lesions depends mainly on the ratio between the size and the difference of the lesion to the background. A large lesion might be visible without administration of CM, whilst a smaller lesion needs the addition of CM to become visible. Additionally, CM can be useful in the characterization of liver lesions. Heiken et al. (1995) found that an attenuation of the parenchyma after CM administration of at least ∆ 50 Hounsfield units (HU) compared to an unenhanced scan (in the same patient) is necessary to recognize liver lesions. This study proposed a dosing factor of 0.521 g I/kg to be necessary to reach such attenuation at a tube voltage of 120 kV [1].
The parenchymal enhancement depends on patient, CT scanner and CM factors. Weight, height, cardiac output, age, gender, venous access, breath-holding, renal function and comorbidity all fall under patient factors [8]. Recently much research showed preferable outcomes for individualized CM injection protocols, in which the contrast bolus is adapted to patient TBW, LBW or body surface area (BSA) [6, 7, 9, 13-15]. In a recent feasibility study in the department of the investigators, the attenuation of the liver parenchyma was evaluated. Results showed that a body weight adapted CM injection protocol resulted in more homogeneous liver enhancement compared to a fixed CM dose (not published yet).
With recent technological developments in X-ray tube technology it became possible to use lower tube voltages. As a result making it possible to perform scans with a sufficient image quality (IQ) and a low tube voltage and therefore a lower radiation dose [10]. Another advantage lies in the fact that reducing the tube voltage, approaching 33 keV k-edge of iodine, results in an increase in attenuation of the iodine. The new technological developments make it possible to reduce the radiation dose and CM volume at the same time. So reducing the tube voltage, makes it also possible to reduce the CM volume.
As recommended by the supplier, it is possible to calculate the total iodine load (TIL) that can be spared with the use of lower kV settings [16]. A reduction of 10 kV should result in a 10% reduction in CM volume. Reducing the tube voltage from 120 to 90 kV should therefore lead to a 30% reduction in CM volume. As mentioned before it is preferred to use an individualized CM injection protocol based on TBW or LBW. For this study, this theory is adapted to the concept of TBW. The following indicates which dosing factors should be used for each kV setting, based on the recommendations mentioned in the above.
120 kV -> 0.521 g I/kg 110 kV -> 0.469 g I/kg 100 kV -> 0.417 g I/kg 90 kV -> 0.365 g I/kg 80 kV -> 0.313 g I/kg 70 kV -> 0.261 g I/kg
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Triple (Participant, Care Provider, Investigator)
盲法说明
A computer random number generator prepares the randomization schedule in a 1:1:1:1 manner, which is balanced randomization. Stratification is performed, based on age (< 60 and ≥ 60 years) and weight < 75 and ≥ 75 kg). Variable block randomization will distribute patients equally over time.
The blinding and randomization process will be conducted by Clinical Trial Centre Maastricht (CTCM, www.CTCM.nl) with a randomization program (ALEA) designed for usage of different techniques.
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 referred for abdominal CT in portal venous phase
- •Patients ≥ 18 years and competent to sign an informed consent
排除标准
- •Hemodynamic instability
- •Pregnancy
- •Renal insufficiency (defined as Glomerular Filtration Rate (GFR) < 30 mL/min/1,73m2 [Odin protocol 004720])
- •Iodine allergy (Odin protocol 022199)
- •Age <18 years
- •Absence of informed consent
结局指标
主要结局
A liver attenuation (Δ HU)
时间窗: Measurement for each scan is performed withing 1 month after the scan.
The attenuation of the liver parenchyma as assessed by measuring the Hounsfield units (HU) of the liver parenchyma in an unenhanced CT scan and a scan in portal venous phase. The difference between the enhanced and unenhanced CT scan is the Δ HU. It is expected that scans in all groups have a Δ HU of at least 50 HU, which is considered sufficient. Therefore it is a non-inferiority outcome.
次要结局
- Objective image quality - signal-to-noise and contrast-to-noise ratio(Measurement for each scan is performed within 1 month after the scan.)
- Weight(Directly prior to the scan it is measured and data is collected within one month after the scan.)
- Contrast media volume(Data is retrieved from the system within 1 month after the scan.)
- BMI(Calculated after the scan, within 1 month after the scan.)
- Sex(Collected before the scan by the technician and retrieved from the system within 1 month after the scan.)
- Scan indication(Collected before the scan by the technician and retrieved from the system within 1 month after the scan.)
- Subjective image quality - assessed with a 5-point Likert scale(Measurement for each scan is performed within 1 month after the scan.)
- Radiation dose(Measurement for each scan is performed within 1 month after the scan.)
- Needle placement(Data is retrieved from the system within 1 month after the scan.)
- Age(Collected before the scan by the technician and retrieved from the system within 1 month after the scan.)
- Flow rate(Data is retrieved from the system within 1 month after the scan.)
- Height (in m)(Directly prior to the scan it is measured and data is collected within one month after the scan.)
- Needle size(Data is retrieved from the system within 1 month after the scan. It is finished when all patients are scanned.)
- Concentration of the contrast media(Data is retrieved from the system within 1 month after the scan.)