缺乏可靠的预测性生物标志物以指导有效疗法，是高级别胶质瘤（特别是胶质母细胞瘤）疗法进展的一个重要障碍，而该疾病是为数不多在过去几十年中未见改善预后的癌症之一。通过本次初步临床试验（NCT04135807号），我们首次证明药物释放型肿瘤内微器械（IMDs）的安全有效，可以用于获取患者特异性的高通量分子和组织病理学药物反应特征。这些数据可以补充其他策略，以根据其体内观察到的抗肿瘤效果来选择药物。IMDs被整合到肿瘤切除手术中，并仅在标准手术（2到3小时）期间保留在位。6名参与患者中没有人出现与IMD相关的不良事件，并且所暴露的组织可供12个检查样本中的11个进行下游分析。分析这些样本，初步证据表明其可靠性、与广泛分子组织检测技术的兼容性以及与可观察到的临床放射学对替莫唑胺的反应类似。在研究方面，IMDs可以获得大量信息，以在完整肿瘤的生理环境中，不影响标准手术流程，对任何感兴趣的药物进行组织效果的表征。

The lack of reliable predictive biomarkers to guide effective therapy is a major obstacle to the advancement of therapy for high-grade gliomas, particularly glioblastoma (GBM), one of the few cancers whose prognosis has not improved over the past several decades. With this pilot clinical trial (number NCT04135807), we provide first-in-human evidence that drug-releasing intratumoral microdevices (IMDs) can be safely and effectively used to obtain patient-specific, high-throughput molecular and histopathological drug response profiling. These data can complement other strategies to inform the selection of drugs based on their observed antitumor effect in situ. IMDs are integrated into surgical practice during tumor resection and remain in situ only for the duration of the otherwise standard operation (2 to 3 hours). None of the six enrolled patients experienced adverse events related to the IMD, and the exposed tissue was usable for downstream analysis for 11 out of 12 retrieved specimens. Analysis of the specimens provided preliminary evidence of the robustness of the readout, compatibility with a wide array of techniques for molecular tissue interrogation, and promising similarities with the available observed clinical-radiological responses to temozolomide. From an investigational aspect, the amount of information obtained with IMDs allows characterization of tissue effects of any drugs of interest, within the physiological context of the intact tumor, and without affecting the standard surgical workflow.