NMR Scanning on Patients

对患者进行核磁共振扫描

• 批准号: 6431767
• 负责人: peter L choyke
• 金额: --
• 依托单位: CLINICAL CENTER
• 依托单位国家: 美国
• 资助国家: 美国
• 起止时间: 至
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/6431767
• 关键词: alveolar macrophages; bioimaging /biomedical imaging; clinical research; diagnostic respiratory lavage; endotoxins; genetic transcription; human subject; immunochemistry; inflammation; informed consent; magnetic resonance imaging; messenger RNA; nuclear magnetic resonance spectroscopy; polymerase chain reaction; transposon /insertion element; tumor necrosis factor alpha

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.

这项研究允许在接受食品药品监督管理局（FDA）批准之前测试磁共振成像（MRI）扫描技术。该协议允许在临床中心进行的MRIS以“研究模式”进行操作，并允许DRD尽快利用自己的发展，以维持用于患者扫描的MRI诊断技术的最新MERI诊断技术。尽管这些技术没有对患者的风险，但FDA坚持认为，使用脉冲序列进行扫描的患者（尚未明确确定其疗效的患者）必须获得知情同意，并且该过程必须在研究所审查委员会的主持下。自1984年以来，该协议一直在连续使用。在过去的一年中，我们扫描了大约7,500名新受试者，没有副作用或并发症。出于安全原因，我们最近添加了清单的透皮斑块，这些贴片据报道会导致MR单位和手术植入物（如IVC过滤器和心室 - 腹膜分流器）的燃烧，这些植入物有时会引起严重的伪影。由于MRI技术继续前进，我们将继续将受试者注册到该协议中。