高剂量钆喷酸葡胺用于脑转移瘤磁共振评估的III期多中心试验。
Phase III multicenter trial of high-dose gadoteridol in MR evaluation of brain metastases.
作者信息
Yuh W T, Fisher D J, Runge V M, Atlas S W, Harms S E, Maravilla K R, Mayr N A, Mollman J E, Price A C
机构信息
Department of Radiology, University of Iowa College of Medicine, Iowa City.
出版信息
AJNR Am J Neuroradiol. 1994 Jun;15(6):1037-51.
PURPOSE
To assess the efficacy and safety profile of high-dose (0.3 mmol/kg cumulative dose) gadoteridol in patients with suspected central nervous system metastatic disease.
METHODS
We studied 67 patients using an incremental-dose technique. Patient monitoring included a medical history, physical examination, vital signs, and extensive laboratory tests within 24 hours before and after the MR examination. Precontrast T1- and T2-weighted spin-echo studies were performed, followed by intravenous injection of 0.1 mmol/kg of gadoteridol. T1-weighted images were acquired immediately after and at 10 and 20 minutes after injection. At 30 minutes an additional 0.2 mmol/kg of gadoteridol was administered (0.3-mmol/kg cumulative dose), and T1-weighted images were acquired. Cases demonstrating abnormal MR findings were assessed for efficacy by unblinded and blinded reviewers and were analyzed quantitatively.
RESULTS
Three adverse effects in two patients were considered to be related to gadoteridol administration. No adverse effects were serious; all self-resolved. Forty-nine cases showed abnormal MR findings and were included in the efficacy analysis. A significantly greater number of lesions was seen on the high-dose as opposed to the standard-dose images. Blinded and unblinded readers identified 5 and 8 patients, respectively, with solitary lesions on standard-dose examination and multiple lesions on high-dose examination. Two patients who had normal standard-dose findings had lesions identified on high-dose studies. Quantitative analysis of 133 lesions in 45 patients demonstrated significant increases in lesion signal intensity on high-dose studies when compared with standard-dose studies.
CONCLUSION
Gadoteridol can be safely administered up to a cumulative dose of 0.3 mmol/kg. High-dose contrast studies provide improved lesion detectability and additional diagnostic information over studies performed in the same patients with a 0.1-mmol/kg dose and aid in patient diagnosis and treatment. High-dose gadoteridol study may facilitate the care of patients with suspected central nervous system metastasis.
目的
评估高剂量（累积剂量0.3 mmol/kg）钆特醇对疑似中枢神经系统转移瘤患者的疗效和安全性。
方法
我们采用递增剂量技术研究了67例患者。患者监测包括病史、体格检查、生命体征以及磁共振检查前后24小时内的广泛实验室检查。在静脉注射0.1 mmol/kg钆特醇之前，先进行了T1加权和T2加权自旋回波预增强研究。注射后立即、10分钟和20分钟采集T1加权图像。30分钟时再给予0.2 mmol/kg钆特醇（累积剂量0.3 mmol/kg），并采集T1加权图像。对显示磁共振异常结果的病例，由非盲和盲态的评估者评估疗效并进行定量分析。
结果
两名患者出现的3例不良反应被认为与钆特醇给药有关。无严重不良反应；均自行缓解。49例显示磁共振异常结果并纳入疗效分析。与标准剂量图像相比，高剂量图像上可见的病灶数量明显更多。盲态和非盲态的阅片者分别识别出5例和8例在标准剂量检查时为孤立病灶、在高剂量检查时为多发病灶的患者。两名标准剂量检查结果正常的患者在高剂量检查时发现有病灶。对45例患者的133个病灶进行的定量分析表明，与标准剂量研究相比，高剂量研究中病灶信号强度显著增加。
结论
钆特醇累积剂量达0.3 mmol/kg时可安全给药。与以0.1 mmol/kg剂量对同一患者进行的研究相比，高剂量对比剂研究可提高病灶的可检测性并提供更多诊断信息，有助于患者的诊断和治疗。高剂量钆特醇研究可能有助于疑似中枢神经系统转移瘤患者的护理。
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