Zoarski G H, Lufkin R B, Bradley W G, Flanders A E, Gale D R, Harms S E, Haughton V M, Joy S E, Kanal E, Rosa L
Department of Radiological Sciences, University of California, Los Angeles 90024.
AJNR Am J Neuroradiol. 1993 Jul-Aug;14(4):955-61.
To evaluate the safety and efficacy of gadoteridol as an MR contrast agent in patients with suspected head and neck pathology.
One hundred thirty-three adult patients were studied with MR at 12 clinical trial sites before and after the intravenous administration of 0.10 mmol/kg gadoteridol. After enrollment, patients underwent a complete physical examination. Patient monitoring included vital signs, laboratory tests, and recording of the incidence and duration of adverse events. To evaluate efficacy, postcontrast T1-weighted images were compared with precontrast T1- and T2-weighted images. Investigators having clinical information evaluated 129 studies for efficacy; two readers blinded to clinical information subsequently evaluated 122 studies using the same criteria as the investigators.
Eight patients (6.0%) experienced mild adverse events possibly or probably related to contrast administration, all of which resolved without treatment. Two clinically significant laboratory abnormalities considered related or possibly related to the administration of gadoteridol were reported in two patients. Enhancement of pathology was seen in 82.9% of cases evaluated by investigators at the study site and in 78.7% of cases subsequently evaluated by the blinded readers. Postcontrast images were judged by investigators to provide additional diagnostic information over precontrast images in 68.9% of studies. The additional diagnostic information available on postcontrast studies most often consisted of improved visualization of pathology and better definition of lesion borders. The use of this information might have contributed to a change in patient diagnosis in 18.6% of the cases evaluated by the investigators and in 16.4% of the cases reviewed by the blinded readers.
Preliminary results show gadoteridol to be a safe and efficacious contrast agent for enhanced MR study of extracranial and extraspinal head and neck pathology.
评估钆特醇作为磁共振造影剂在疑似头颈部病变患者中的安全性和有效性。
133例成年患者在12个临床试验地点接受了静脉注射0.10 mmol/kg钆特醇前后的磁共振检查。入组后，患者接受了全面的体格检查。患者监测包括生命体征、实验室检查以及不良事件的发生率和持续时间记录。为评估有效性，将增强后的T1加权图像与增强前的T1加权和T2加权图像进行比较。掌握临床信息的研究人员评估了129项研究的有效性；随后，两名对临床信息不知情的阅片者按照与研究人员相同的标准评估了122项研究。
8例患者（6.0%）出现了可能或很可能与造影剂注射相关的轻度不良事件，所有这些事件未经治疗即自行缓解。两名患者报告了被认为与钆特醇注射相关或可能相关的两项具有临床意义的实验室异常。研究现场的研究人员评估的病例中有82.9%出现了病变强化，随后不知情的阅片者评估的病例中有78.7%出现了病变强化。研究人员判断，在68.9%的研究中，增强后的图像比增强前的图像提供了更多的诊断信息。增强后研究中可获得的额外诊断信息大多包括病变可视化改善和病变边界更清晰。在研究人员评估的病例中，有18.6%的病例以及在不知情的阅片者复查的病例中，有16.4%的病例使用这些信息可能导致了患者诊断的改变。
初步结果表明，钆特醇是用于颅外和脊柱外头颈部病变增强磁共振研究的一种安全有效的造影剂。
