Gadofosveset Trisodium (Ablavar, Gdfos) in Distinguishing Hemangiomas and Metastases: A Prospective Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Reader diagnostic accuracy using Gdfos vs. EcGd compared to gold standard
研究概览
简要总结
The purpose of this study is to determine if Gadofosveset Trisodium (Gdfos, Ablavar) is a useful magnetic resonance imaging (MRI) contrast agent in accurately diagnosing liver metastases compared to the standard agent gadobutrol (EcGd, Gadovist).
详细描述
The proposed study will be a single centre, prospective trial comparing the sensitivity and specificity of using Gadofosveset Trisodium (Gdfos, Ablavar) as the MRI contrast agent as compared to gadobutrol (EcGd, Gadovist).
The study population will include cancer patient's referred for an MRI study of the liver to rule out metastases. Those who meet the inclusion/exclusion criteria will their routine (clinical) MRI of the liver with EcGd. They will also receive an additional MRI with Gdfos within 4 weeks of the original study.
The patient data will be anonymized and the imaging will be read by radiologists and radiology residents and comparison will be made between the diagnostic accuracy of the EcGd-enhanced study and the Gdfos-enhanced study.
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
- Single (Outcomes Assessor)
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
- •known cancer
- •referred for MRI of liver to rule out metastases
- •has focal liver lesions
- •age > 18 yo
排除标准
- •contraindication to MRI or MR contrast agents
- •pregnancy
- •unable to obtain all sequences and/or acceptable quality imaging
结局指标
主要结局
Reader diagnostic accuracy using Gdfos vs. EcGd compared to gold standard
时间窗: Participants will receive both Gdfos and EcGd study within 4 weeks of each other. Radiologist reading for the study will be done up to 52 weeks after first MRI has been performed.
Three blinded radiologists of different training levels will read the MRI liver studies done using Gdfos and EcGd and the results of this will be compared to a gold standard (either pathology from surgery or biopsy or long-term follow-up). The diagnostic accuracy of Gdfos vs. EcGd will be compared using area under receiver operating characteristic (ROC) curves (with correction for correlation and clustering).
次要结局
- Inter-reader variability for EcGd-enhanced vs. Gdfos-enhanced imaging(Participants will receive both Gdfos and EcGd study within 4 weeks of each other. Radiologist reading for the study will be done up to 52 weeks after first MRI has been performed.)
- Reader diagnostic accuracy of EcGd-enhanced imaging vs. Gdfos-enhanced imaging compared to gold standard (subgroup analysis for small lesions less than or equal to 1cm)(Participants will receive both Gdfos and EcGd study within 4 weeks of each other. Radiologist reading for the study will be done up to 52 weeks after first MRI has been performed.)