Centre for Medical Imaging, University College London, London, UK.
Institute of Applied Health Research, NIHR Birmingham Biomedical Research Centre, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.
Lancet Respir Med. 2019 Jun;7(6):523-532. doi: 10.1016/S2213-2600(19)30090-6. Epub 2019 May 9.
Whole-body magnetic resonance imaging (WB-MRI) could be an alternative to multi-modality staging of non-small-cell lung cancer (NSCLC), but its diagnostic accuracy, effect on staging times, number of tests needed, cost, and effect on treatment decisions are unknown. We aimed to prospectively compare the diagnostic accuracy and efficiency of WB-MRI-based staging pathways with standard pathways in NSCLC.
The Streamline L trial was a prospective, multicentre trial done in 16 hospitals in England. Eligible patients were 18 years or older, with newly diagnosed NSCLC that was potentially radically treatable on diagnostic chest CT (defined as stage IIIb or less). Exclusion criteria were severe systemic disease, pregnancy, contraindications to MRI, or histologies other than NSCLC. Patients underwent WB-MRI, the result of which was withheld until standard staging investigations were complete and the first treatment decision made. The multidisciplinary team recorded its treatment decision based on standard investigations, then on the WB-MRI staging pathway (WB-MRI plus additional tests generated), and finally on all tests. The primary outcome was difference in per-patient sensitivity for metastases between standard and WB-MRI staging pathways against a consensus reference standard at 12 months, in the per-protocol population. Secondary outcomes were difference in per-patient specificity for metastatic disease detection between standard and WB-MRI staging pathways, differences in treatment decisions, staging efficiency (time taken, test number, and costs) and per-organ sensitivity and specificity for metastases and per-patient agreement for local T and N stage. This trial is registered with the International Standard Randomised Controlled Trial registry, number ISRCTN50436483, and is complete.
Between Feb 26, 2013, and Sept 5, 2016, 976 patients were screened for eligibility. 353 patients were recruited, 187 of whom completed the trial; 52 (28%) had metastasis at baseline. Pathway sensitivity was 50% (95% CI 37-63) for WB-MRI and 54% (41-67) for standard pathways, a difference of 4% (-7 to 15, p=0·73). No adverse events related to imaging were reported. Specificity did not differ between WB-MRI (93% [88-96]) and standard pathways (95% [91-98], p=0·45). Agreement with the multidisciplinary team's final treatment decision was 98% for WB-MRI and 99% for the standard pathway. Time to complete staging was shorter for WB-MRI (13 days [12-14]) than for the standard pathway (19 days [17-21]); a 6-day (4-8) difference. The number of tests required was similar WB-MRI (one [1-1]) and standard pathways (one [1-2]). Mean per-patient costs were £317 (273-361) for WBI-MRI and £620 (574-666) for standard pathways.
WB-MRI staging pathways have similar accuracy to standard pathways, and reduce the staging time and costs.
UK National Institute for Health Research.
全身磁共振成像（WB-MRI）可能是一种替代非小细胞肺癌（NSCLC）多模式分期的方法，但它的诊断准确性、对分期时间的影响、所需检查的数量、成本以及对治疗决策的影响尚不清楚。我们旨在前瞻性比较基于 WB-MRI 的分期途径与 NSCLC 标准途径的诊断准确性和效率。
Streamline L 试验是一项在英格兰 16 家医院进行的前瞻性、多中心试验。合格的患者为 18 岁或以上，新诊断为潜在可根治性治疗的 NSCLC，即诊断性胸部 CT 分期为 IIIb 期或更早期（定义为 IIIb 期或更早期）。排除标准为严重系统性疾病、妊娠、MRI 禁忌症或非 NSCLC 组织学。患者接受 WB-MRI 检查，结果在标准分期检查完成并做出首次治疗决策后才公布。多学科团队根据标准检查记录其治疗决策，然后根据 WB-MRI 分期途径（WB-MRI 加额外生成的检查），最后根据所有检查记录。主要结局是在 12 个月时，根据共识参考标准，标准和 WB-MRI 分期途径对转移的每例患者的敏感性差异，以符合方案人群为准。次要结局是标准和 WB-MRI 分期途径对转移性疾病检测的每例患者特异性差异、治疗决策差异、分期效率（时间、检查数量和成本）以及转移的每器官敏感性和特异性以及局部 T 和 N 分期的每例患者一致性。该试验在国际随机对照试验注册中心（ISRCTN）注册，编号为 ISRCTN50436483，现已完成。
2013 年 2 月 26 日至 2016 年 9 月 5 日期间，对 976 名患者进行了筛选，以确定其是否符合条件。共招募了 353 名患者，其中 187 名完成了试验；基线时有 52 名（28%）患者发生转移。WB-MRI 的途径敏感性为 50%（95%CI 37-63），标准途径为 54%（41-67），差异为 4%（-7 至 15，p=0.73）。未报告与影像学相关的不良事件。WB-MRI（93%[88-96]）和标准途径（95%[91-98]）的特异性无差异（p=0.45）。与多学科团队的最终治疗决策的一致性为 WB-MRI 为 98%，标准途径为 99%。WB-MRI 完成分期的时间（13 天[12-14]）比标准途径（19 天[17-21]）短；相差 6 天（4-8）。所需的检查数量相似，WB-MRI 为 1 个[1-1]，标准途径为 1 个[1-2]。每位患者的平均成本为 WB-MRI 为 317 英镑（273-361），标准途径为 620 英镑（574-666）。
WB-MRI 分期途径与标准途径具有相似的准确性，并可减少分期时间和成本。
英国国家卫生研究院。
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