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临床试验/NCT02234375
NCT02234375撤回4 期

Efficacy of Gadolinium Contrast in CT Pulmonary Angiography in Patients With Allergy to Iodine

Massachusetts General Hospital1 个研究点 分布在 1 个国家开始时间: 2017年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
撤回
试验地点
1
主要终点
Diagnosis of Pulmonary Embolism

研究概览

简要总结

The study will investigate patients with clinical suspicion for pulmonary embolism (PE) who have a contraindication to iodine based contrast. These patients normally get investigated with studies such as ultrasound and nuclear medicine studies but the fastest and preferred investigation is CT with contrast to look for filling defects in the pulmonary arteries. The investigators will assess whether gadolinium, which is currently used with MRI can be used with CT as an alternative effective contrast in diagnosis or exclusion of PE. A new type of CT scanner, a Dual Energy Scanner will be used to improve the visibility of Gadolinium contrast on CT.

详细描述

Contrast enhancement with Gadolinium will be evaluated to assess its efficacy for diagnosis and exclusion of pulmonary embolism in a patient who previously would not have been investigated with CTPA due to an underlying allergy to contrast or other contraindication. If this proves beneficial, it will allow such patients to be investigated successfully with CTPA

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients suspected of having a Pulmonary embolus
  • Allergy to Iodine based intravenous contrast

排除标准

  • Renal impairment
  • Less than 20 years of age
  • Non-English speaking
  • Pregnancy
  • Allergy to Gadolinium

研究组 & 干预措施

Gadolinium enhancement

Experimental

Gadolinium enhancement will be performed using intravenous Dotarem[recommended dose of 0.2 mL/kg (0.1 mmol Gd/kg )]

干预措施: Gadolinium (Drug)

结局指标

主要结局

Diagnosis of Pulmonary Embolism

时间窗: 24 hours

Ability of Gadolinium to diagnose pulmonary embolism on a dual energy CT scan

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Amita Sharma, MD

Radiologist

Massachusetts General Hospital

研究点 (1)

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