Interim analysis of triple-blind, randomised iMRI trial proves better results for glioma patients


Imris has announced that neurosurgeons from Huashan Hospital at Fudan University in Shanghai, China, have received a clinical journal award for their preliminary results that suggest high-field intraoperative MRI (iMRI) within the Visius Surgical Theatre contributes to increased complete resection rates in glioma tumours. 

The neurosurgical team led by Jin-song Wu was honoured with the Journal of Neuro-Oncology Award at the Congress of Neurological Surgeons (CNS) Annual Meeting, 19–23 October in San Francisco, USA, for their presented research.

When completed, Wu and colleagues postulate that the prospective, parallel, randomised, triple-blind controlled trial will provide the highest level evidence to date of the value of iMRI in treating both low- and high-grade gliomas. The early results were said to reinforce that high-field iMRI-guided surgery is more effective in achieving complete resection than conventional neuronavigation-guided surgery. Other published studies on high-field iMRI have been mainly retrospective.

“Our preliminary results confirm some of the assumptions that intraoperative MRI enables reliable resection control to eliminate the effect of brain shift on extent of resection,” Wu says. “This leads to more improved progression-free survival and quality of life than using conventional neuronavigation. Although these are early results we believe they are showing trends to statistical significance and will be the highest level of iMRI evidence for glioma surgery to date.”

With 114 patients enrolled, complete resection rates in the iMRI group and control group were 86% and 53%, respectively. These results are supported by volumetric analysis of extent of resection and noted as being statistically significant.

“Level-one evidence is the strongest clinical evidence available and is important in developing standard of care and reimbursement,” comments Jay D Miller, Imris CEO and president. “We look forward to the continuation of this trial and further results.”

Huashan Hospital is one of three Visius Surgical Theatre installations in China with iMRI suites currently in development at two other Chinese hospitals.