The National Institute for Health Research (NIHR)-Wellcome Trust Imperial College Clinical Research Facility, Imperial Centre for Translational and Experimental Medicine, Imperial College, Hammersmith Hospital Campus, London, United Kingdom.
PLoS One. 2012;7(11):e49814. doi: 10.1371/journal.pone.0049814. Epub 2012 Nov 16.
The detection of incidental findings (IF) in magnetic resonance imaging (MRI) studies is common and increases as a function of age. Responsible handling of IF is required, with implications for the conduct of research and the provision of good clinical care.
To investigate the prevalence and clinical significance of IF in a prospective cohort of healthy elderly volunteers who underwent MRI of the torso as a baseline investigation for a phase I trial. We assessed the follow-up pathway with consequent cost implications and impact on trial outcomes.
A total of 29 elderly healthy volunteers (mean age 67, range 61-77, 59% female) were eligible at screening and underwent MRI for assessment of visceral and subcutaneous fat.
IF were detected in 19 subjects (66%). Suspected IF of high and low clinical significance were found in 14% and 52% of participants, respectively. Follow up of IF was conducted in 18 individuals, confirming abnormalities in 13 subjects, 3 of whom were recommended for deferred clinical re-evaluation. The remaining 5 subjects had false positive IF based on second line imaging tests. Costs of follow-up medical care were considerable.
MRI abnormalities are common in elderly individuals, as a result of age and non-diagnostic quality of research scans. In the presence of IF in the context of clinical trials, immediate referrals and follow up assessments may be required to rule out suspected pathology prior to exposing trial participants to investigational medicine products (IMP). Unanticipated costs, ethical implication and the possible impact of IF on trial outcomes need to be taken into account when designing and conducting trials with an IMP.
磁共振成像（MRI）研究中偶然发现（IF）的检测很常见，并且随着年龄的增长而增加。需要负责任地处理 IF，这对研究的进行和提供良好的临床护理都有影响。
调查一项 I 期试验的基线研究中，一组健康老年志愿者进行躯干 MRI 检查时 IF 的发生率和临床意义。我们评估了后续路径及其对试验结果的成本影响。
共有 29 名符合条件的健康老年志愿者（平均年龄 67 岁，范围 61-77 岁，59%为女性）在筛选时接受 MRI 检查，以评估内脏和皮下脂肪。
19 名受试者（66%）检测到 IF。高、低临床意义疑似 IF 的受试者分别占 14%和 52%。18 名受试者进行了 IF 随访，其中 13 名受试者的异常情况得到了证实，其中 3 名建议推迟临床再评估。其余 5 名受试者的二线影像学检查结果为假阳性 IF。随访医疗费用相当可观。
MRI 异常在老年人群中很常见，这是由于年龄和非诊断性研究扫描质量所致。在临床试验中存在 IF 的情况下，可能需要立即转诊并进行后续评估，以在将试验参与者暴露于研究药物产品（IMP）之前排除疑似病理。在设计和进行有 IMP 的试验时，需要考虑意外成本、伦理影响和 IF 对试验结果的可能影响。
