IodiNe Subtraction maPpIng in the Diagnosis of chRonic Pulmonary thromboEmbolic Disease (INSPIRE): An Observational Diagnostic Study
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Assessment of the diagnostic performance of CT-LSIM for evaluation of pulmonary perfusion in patients with known or suspected chronic thromboembolic pulmonary hypertension (CTEPH)
研究概览
简要总结
Chronic thromboembolic pulmonary hypertension (CTEPH) is a severe but treatable disease that is commonly underdiagnosed. Computed tomography lung subtraction iodine mapping (CT-LSIM) in addition to standard CT pulmonary angiography (CTPA) may improve the evaluation of suspected chronic pulmonary embolism and improve the diagnostic pick up rate. The investigators aim to recruit 100 patients suspected of having CTEPH and perform CT-LSIM scans in addition to the current gold standard test of nuclear medicine test (lung single photon emission computed tomography (SPECT) imaging) as a pilot study which will contribute to and inform the definitive trial. The diagnostic accuracy of CT-LSIM and lung SPECT will be compared. The primary outcome of the full definitive study is non-inferiority of CT-LSIM versus lung SPECT imaging.
详细描述
Chronic thromboembolic pulmonary hypertension (CTEPH) is a treatable, life-threatening disease that occurs in up to 4% of patients following acute pulmonary embolism (PE)(1). The disease is characterised by remodelling of the pulmonary arteries due to poor clearance of clot. Prognosis is very poor without treatment, and pulmonary endarterectomy (PEA) is well established as the definitive and potentially curative treatment method for CTEPH.
The European Society of Cardiology recommends ventilation/perfusion single photon emission tomography (V/Q SPECT) as the first line-screening test for patients with CTEPH. The perfusion image involves injection of 99mTc labelled macroaggregated human albumin, exposing the patient to ionizing radiation and the study acquisition time is 30-40 minutes.
Evaluation of the pulmonary arterial tree by computed tomography pulmonary angiography (CTPA) and lung perfusion is required to determine the appropriate treatment strategy in chronic thromboembolic disease (CTED). Recently, there has been much interest in the application of lung perfused blood volume images using dual-energy CT (DECT) to assess lung perfusion (2, 3). However, DECT is not widely available in hospitals across the UK and V/Q SPECT remains the reference standard. The rationale, methodology and design of the IodiNe SubtracTion mappInG in the diAgnosis of chronic pulmonary ThromboEmbolic disease (INSTIGATE) study are summarised in this paper.
Rationale of the INSTIGATE study:
Computed tomography lung subtraction iodine mapping (CT-LSIM) and accompanying software is now available in routine clinical practice (Sure subtractionTM, Toshiba Medical Systems; FDA report K130960). CT-LSIM images are created using on a non-rigid registration of a low dose unenhanced thoracic CT to a CTPA, with both examinations performed during the same sitting in less than 10 minutes total scanning time. Subtraction of the non-contrast CT from the contrast-enhance CTPA produces the CT-LSIM. CT-LSIM simultaneously provide high-spatial-resolution images of the pulmonary arterial tree and parenchymal anatomy in combination with functional examination of lung perfusion.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients suspected to have CTED and require a SPECT and CTPA
排除标准
- •Less than 18 years old
- •Unable to provide informed consent
- •Significant renal dysfunction (GFR <30ml/min)
- •History of hypersensitivity to contrast material
- •Pregnancy
结局指标
主要结局
Assessment of the diagnostic performance of CT-LSIM for evaluation of pulmonary perfusion in patients with known or suspected chronic thromboembolic pulmonary hypertension (CTEPH)
时间窗: 12 months
Sensitivity and specificity
次要结局
- Diagnostic accuracy of experienced and less experienced observers(12 months)
- Diagnostic accuracy of CT-LSIM compared with single photon emission computed tomography (SPECT)(12 months)
- Number of alternate diagnoses made on CT-LSIM over lung SPECT imaging(12 months)
- Radiation dose between CT-LSIM, SPECT and CTPA(12 months)
- Diagnostic accuracy of CT-LSIM compared with CT pulmonary angiography (CTPA)(12 months)
研究者
Andy J Swift
Principal Investigator and Wellcome Trust Clinical Fellow in Radiology and Consultant Cardiothoracic Radiologist
University of Sheffield