NMR Scanning on Patients

这项研究允许在美国食品药品监督管理局（FDA）批准之前对磁共振成像（MRI）扫描技术进行测试。该协议允许在临床中心进行的MRI以“研究模式”运行，并允许DRD尽快利用发展，以保持最新的MRI诊断技术菜单，用于患者扫描。虽然这些技术对患者没有风险，但FDA坚持认为，接受脉冲序列扫描的患者，其疗效尚未明确确定，必须获得知情同意，并且这一过程必须在研究所审查委员会的主持下进行。该协议自1984年以来一直在使用。在过去的一年里，我们已经扫描了大约7,500名新受试者，没有副作用或并发症。出于安全原因，我们最近在我们的清单中添加了经皮贴剂，据报道，经皮贴剂会导致MR设备和外科植入物（如IVC过滤器和脑室-腹腔分流器）的烧伤，这些植入物有时会导致严重的伪影。由于MRI技术不断进步，我们将继续招募受试者进入本方案。

This study allows the testing of magnetic resonance imaging (MRI) scanning techniques prior to their approval by the Food and Drug Administration (FDA). The protocol permits MRIs performed at the Clinical Center to be operated in a "research mode" and has allowed the DRD to avail itself of developments as rapidly as possible to maintain the most up-to-date-menu of MRI diagnostic techniques for patient scanning. While there is no risk to the patient from these techniques, the FDA insists that patients who undergo scanning with pulse sequences, whose efficacy has not been unequivocally established, must be given informed consent and this process must be under the auspices of an Institute Review Board. This protocol has been in continuous use since 1984. In the past year we have scanned approximately 7,500 new subjects, without side effects or complications. For safety reasons, we have recently added to our checklist transdermal patches that have been reported to cause burns in MR units and surgical implants like IVC filters and ventriculo-peritoneal shunts that have sometimes caused severe artifacts. Since MRI technology continues to advance, we will continue to enroll subjects into this protocol.