MR Pulmonary Angiography to Replace CT Pulmonary Angiography for Patients With a Suspicion of a Pulmonary Embolism
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 272
- 主要终点
- Sensitivity
研究概览
简要总结
Rational: The first choice of imaging modality for patients with a suspicion of pulmonary embolism is CT pulmonary angiography (CTPA). Our goal is to avoid extra cases of cancer due to the carcinogenic effect of ionizing radiation from using CTPA. This carcinogenic effect is greatest in women under 40. In the Netherlands, at least 100,000 CTPA's are performed each year, 10% of which are in women under 40 years old, resulting in at least 10 extra tumors induced per year. The goal is to investigate whether MR Pulmonary angiography (MRPA) can serve as an alternative to CTPA. If it can replace CTPA, this will result in a significant health benefit.
Objective: the primary objective is to determine the sensitivity and specificity of MR Pulmonary Angiography (MRPA) with CT Pulmonary Angiography (CTPA) as the gold standard.
Secondary outcomes: to determine the clinical applicability of MRPA in daily practice, negative predictive value, positive predictive value, accuracy of MRPA (compared to CTPA), and agreement in assessment between radiologists.
Study design: observational-prospective diagnostic study, an additional MRPA will be performed in patients with a suspicion of pulmonary embolism.
Study population: in patients with clinical suspicion of pulmonary embolism, a standard CTPA is made for exclusion or confirmation of the disease. The study population will consist of 272 patients.
Primary outcome parameters: determining the sensitivity and specificity of MRPA compared to CTPA (gold standard) in patients with a (clinical) suspicion of pulmonary embolism.
Secondary outcome parameters: Determining the negative predictive value, positive predictive value, accuracy, inter-observer agreement with respect to MRPA, and applicability in daily clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Mentally competent
- •18 years old
排除标准
- •Regular exclusion criteria for MR examination,
- •Contrast allergy,
- •Hemodynamic instability,
- •Severe respiratory insufficiency
- •Immobile patient.
- •Pregnancy
- •Dialysis patients
- •COVID-19 positive patients
结局指标
主要结局
Sensitivity
时间窗: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the sensitivity of the MRPA towards CTPA, regarding all patients that have been scanned. Then the sensitivity will be calculated and compared to that of the golden standard CTPA
Specificity
时间窗: At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months
To determine the specificity of the MRPA towards CTPA. To determine the specificity of the MRPA towards CTPA, regarding all patients that have been scanned. Then the specificity will be calculated and compared to that of the golden standard CTPA
次要结局
- To determine the negative predictive value of MRPA(At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months)
- To determine the accuracy of MRPA(At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months)
- To determine the inter-observer agreement / variability of MRPA(At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months)
- To determine the positive predictive value of MRPA(At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months)
- To determine the feasibility in daily clinical practice of MRPA(At the end of the study, so probably around February or March 2024. Time frame of approximately 9 months)
研究者
Jos Wallis
Radiologist
Noordwest Ziekenhuisgroep