Detection of Pulmonary Embolism With CT Pulmonary Angiography Using Reduced Contrast Medium and Radiation Dose: Comparison of 100 kVp and 80 kVp Protocols
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 504
- 试验地点
- 2
- 主要终点
- Accuracy of normal- and low-dose CTPA on composite reference standard
研究概览
简要总结
Computed tomography pulmonary angiography (CTPA) is the imaging method of choice to rule out acute pulmonary embolism based on its high sensitivity and specificity. Unfortunately, CTPA uses iodinated contrast media and can provoke contrast induced nephropathy. On the other hand, Computed tomography uses ionising radiation and is responsible for the half of the radiation exposure coming from medical sources.
Recent studies have proven that low-dose CTPA protocols using Computed tomography tube energy of 80 kVp and reduced volume of iodinated contrast media provide an increased vessel signal and good image quality at a significantly reduced patient exposure. However, there are no data on the sensitivity of low-kVp protocols.
The aim of this prospective randomized trial is to detect any difference between a normal-dose and a low-dose CTPA protocol in the diagnostic accuracy in the detection of acute pulmonary embolism (PE).
详细描述
Background
Pulmonary embolism (PE) is the third most common cause of death in the U.S., with at least 650,000 cases occurring annually. Its frequency is similar in Europe. With the new generation of multi-detector Computed tomography scanners it is possible to depict the pulmonary vascular tree with a single intravenous injection of iodinated contrast medium (CM) in one breath-hold. This non-invasive method can delineate pulmonary arteries to their third-fourth branches and its overall negative predictive value lies above 99%. Therefore, Computed tomography-angiography with multi-detector scanners (MDCTA) is nowadays the preferred modality over conventional angiography or nuclear scintigraphic ventilation-perfusion (V/Q) scanning of the lung to exclude acute Pulmonary embolism(PE).
Unfortunately, Computed tomography uses ionising radiation and is already the largest contributor of radiation dose to the population in the Western countries. Most recent reports suggest that 1.5 to 2% of all fatal cancers are induced by Computed tomography in the U.S, equalling 25,420 cases per year. Furthermore, the rate of young adults with suspected Pulmonary embolism (PE) repeatedly examined with Multidetector Computed Tomography Angiography (MDCTA) is growing. Therefore, policies to reduce patient exposure are becoming more important in order to reduce the risk of developing cancer in the patients´ later life. On the other hand, elderly patients, who often has an impaired renal function or diabetes, may develop contrast induced nephropathy after the application of iodinated contrast media in, which is one of the most common causes of renal failure. Reducing iodine load in this patient group can efficiently prevent nephropathy, saving patients from dialysis and reducing medical costs.
Computed tomography protocols using low x-ray tube potential are capable of lowering radiation exposure with simultaneous increase of signal from the contrasted vessels. Furthermore, the higher vessel signal makes a reduction of the injected iodinated contrast material possible. Thus, low-kVp pulmonary CTA is warranted for routine use not only in younger patients to reduce radiation dose but also in the elderly to reduce the risk of contrast induced nephropathy.
In 2007 we reduced the tube energy of our routine pulmonary Multidetector Computed Tomography Angiography (MDCTA) protocol from 120 to 100 kVp which significantly reduced radiation dose. Our experience in more than 200 patients and results from a simulation study show that 80 kVp CTPA protocols using reduced radiation exposure by 40% and reduced volume of the injected contrast material by 25% provide an excellent image quality and a very good delineation of PE in patients weighing up to 100 kg. However, there is no clinical evidence based from prospective trials on the impact of low-dose CTPA on the detection of PE. Therefore, a large scale prospective randomised study comparing 100 kVp and 80 kVp protocols in respect sensitivity and specificity is warranted.
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
- Single (Participant)
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
- •CTPA (CT pulmonary angiography) indicated based on clinical suspicion for pulmonary embolism
- •patient's body weight < 100 kg
- •informed consent form signed by patient
排除标准
- •contraindication to iodinated contrast media
- •pregnancy (if alternative imaging methods to exclude pulmonary embolism are available)
研究组 & 干预措施
1
Patients examined with normal-dose Computed tomography pulmonary angiography
干预措施: Computed tomography pulmonary angiography (Radiation)
2
Patients examined with low-dose Computed tomography pulmonary angiography
干预措施: Computed tomography pulmonary angiography (Radiation)
结局指标
主要结局
Accuracy of normal- and low-dose CTPA on composite reference standard
时间窗: 90 days after CTPA
Evidence of Pulmonary Embolism (PE) on CT pulmonary angiography (CTPA)
时间窗: 1 hour after CTPA
次要结局
- PE-related death in 90 days after CTPA(90 days after CTPA)
- Evidence of PE or deep venous thrombosis in 90 days following CTPA(90 days after CTPA)
- Diagnostic confidence with normal- and low-dose CTPA(2 months after recruitment of last patient)
- Radiation dose with both CTPA protocols(2 months after recruitment of last patient)
