3.0T iMRI-guided resection of eloquent high-grade gliomas: preliminary results of a randomised controlled trial

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• 作者：Xiu Gong ; MD^a ; Cheng-Jun Yao ; PhD^b ; Shi-Wen Yuan ; MD^b ; Dong-Xiao Zhuang ; PhD^b ; Tian-Ming Qiu ; PhD^b ; Jun-Feng Lu ; PhD^b ; Jie Zhang ; PhD^a ; Yan-Yan Song ; PhD^c ; Prof Wei Zhu ; PhD^a ; Prof Ying Mao ; MD^a ; Prof Jin-Song Wu ; PhD^b ; ^{wjsongc@126.com" class="auth_mail" title="E-mail the corresponding author} ; Prof Liang-Fu Zhou ; MD^a ; ^{lfzhouc@126.com" class="auth_mail" title="E-mail the corresponding author}
• 刊名：The Lancet
• 出版年：2015
• 出版时间：October 2015
• 年：2015
• 卷：386
• 期：supp_S1
• 页码：S11
• 全文大小：60 K

文摘

High-field intraoperative magnetic resonance imaging (iMRI) has been studied in two single-centre randomised trials with patients who have glioblastoma and is hypothesised to enable a greater extent of tumour resection and prolong survival in patients with gliomas. iMRI for glioblastomas has also been shown to be significantly superior to 5-ALA and white-light surgery. However, the real value of iMRI is still a controversial issue. Given that use of this technology is relatively expensive, a high-quality prospective randomised trial is necessary before the approach can be made widely available. We have undertaken a single-centre prospective, randomised controlled trial to assess the clinical efficacy of 3.0T iMRI-guided resection of malignant gliomas compared with conventional neuronavigation only. Here we present the interim analysis of a long-term follow-up of patients with high-grade gliomas.

Methods

Eligible patients were aged 18–70 years with suspected (as assessed by consaltant surgeon), newly diagnosed malignant supratentorial glioma, met the Karnofsky performance scale 70 or above, and for whom gross total resection was intended. Patients were excluded if they had: tumour of the midline, basal ganglia, cerebellum, or brain stem; MRI contraindications; inability to give informed consent; renal or hepatic insufficiency; history of malignant tumours of other systems; or pathology other than astrocytoma, oligodendroglioma, or oligoastoryctoma (WHO grade II to IV). All participants were randomly assigned to either the trial group (iMRI group) or control group (conventional neuronavigation group) after giving written consent. All surgical protocols including conventional neuro-navigation are identical between the two groups; iMRI is specifically used in the trial group. The estimated sample size was 303 patients in the intent-to-treat analysis to give 80% complete power with a type I error of 0·05. Computational randomisation was done when maximal safe resection was achieved by the masked surgeons. The primary endpoint was extent of tumour resection. The secondary endpoints were progression-free survival and overall survival. This trial is registered with linicalTrial.gov">ClinicalTrial.gov, number NCT01479686. This study was approved by the Huashan Institutional Review Board. Written informed consents were given by patients or their attorneys before surgery.

Findings

Between March, 2012, and August, 2015, we enrolled 202 patients, 11 of whom were subsequently excluded because of unbefitting pathology. 177 patients were followed-up more than 6 months and subsequently analysed. 190 patients had low-grade gliomas (51 males vs 39 females, mean age 38·55 years [SD 9·56]), and 87 patients had high-grade gliomas (56 males vs 31 females, mean age 50·42 years [12·18). 43 of the patients with high-grade gliomas were enrolled in the iMRI group, and 44 patients with high-grade gliomas were enrolled in the control group. The extent of tumour resection (iMRI median 100% [IQR 70·87–100] vs control median 98·76% [51·81–100]) and the rate of gross total resection (86% vs 45%) were higher in the iMRI group than that in the control group (p<0·0001). Patients in the iMRI group who had eloquent high-grade gliomas had significantly longer progression-free survival (median not reached vs 13·2 months, p=0·012) and overall survival (median not reached vs 21·5 months, p=0·003) than patients in the control group. No events were identified as side-effects of iMRI.

Interpretation

The results address hypotheses about the clinical benefits of 3.0T iMRI-guided maximal safe resection of glioma. It is practical to increase the extent of tumour resection for high-grade gliomas to prolong progression-free survival and overall survival, especially for eloquent high-grade gliomas.

Funding

National Key Technology R&D Program of China (No. 2014BAI04B05) and the Shanghai Municipal Health Bureau (XBR2011022).