Supra‐maximum surgical tumor resection without neurological damage is highly valuable for treatment and prognosis of patients with glioblastoma multiforme (GBM). We developed a GBM‐specific fluorescence probe using IRDye800CW (peak absorption/emission, 778/795 nm) and bombesin (BBN), which (IRDye800‐BBN) targets the gastrin‐releasing peptide receptor, and evaluated the image‐guided resection efficiency, sensitivity, specificity, and survivability. Twenty‐nine patients with newly diagnosed GBM were enrolled. Sixteen hours preoperatively, IRDye800‐BBN (1 mg in 20 ml sterile water) was intravenously administered. A customized fluorescence surgical navigation system was used intraoperatively. Postoperatively, enhanced magnetic resonance images were used to assess the residual tumor volume, calculate the resection extent, and confirm whether complete resection was achieved. Tumor tissues and nonfluorescent brain tissue in adjacent noneloquent boundary areas were harvested and assessed for diagnostic accuracy. Complete resection was achieved in 82.76% of patients. The median extent of resection was 100% (range, 90.6–100%). Eighty‐nine samples were harvested, including 70 fluorescence‐positive and 19 fluorescence‐negative samples. The sensitivity and specificity of IRDye800‐BBN were 94.44% (95% CI, 85.65–98.21%) and 88.24% (95% CI, 62.25–97.94%), respectively. Twenty‐five patients were followed up (median, 13.5 [3.1–36.0] months), and 14 had died. The mean preoperative and immediate and 6‐month postoperative Karnofsky performance scores were 77.9 ± 11.8, 71.3 ± 19.2, and 82.6 ± 14.7, respectively. The median overall and progression‐free survival were 23.1 and 14.1 months, respectively. In conclusion, GBM‐specific fluorescent IRDye800‐BBN can help neurosurgeons identify the tumor boundary with sensitivity and specificity, and may improve survival outcomes.

中文翻译：

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多形性胶质母细胞瘤特异性 IRDye800-BBN 荧光引导手术临床试验的切除和生存数据


无神经损伤的超最大肿瘤切除术对于多形性胶质母细胞瘤（GBM）患者的治疗和预后非常有价值。我们使用IRDye800CW（峰值吸收/发射，778/795 nm）和铃蟾肽（BBN）开发了GBM特异性荧光探针，其中（IRDye800-BBN）靶向胃泌素释放肽受体，并评估了图像引导切除效率，敏感性、特异性和生存能力。纳入了 29 名新诊断 GBM 患者。术前 16 小时，静脉注射 IRDye800-BBN（1 mg，溶于 20 ml 无菌水）。术中使用定制的荧光手术导航系统。术后利用增强磁共振图像评估残余肿瘤体积，计算切除范围，确认是否完全切除。收获邻近非语言边界区域的肿瘤组织和非荧光脑组织并评估诊断准确性。 82.76%的患者实现完全切除。中位切除范围为 100%（范围，90.6–100%）。收获了 89 个样本，其中 70 个荧光阳性样本和 19 个荧光阴性样本。 IRDye800-BBN 的敏感性和特异性分别为 94.44%（95% CI，85.65-98.21%）和 88.24%（95% CI，62.25-97.94%）。对 25 名患者进行了随访（中位时间 13.5 [3.1-36.0] 个月），其中 14 名患者死亡。术前、术后即刻和术后 6 个月的平均卡氏评分分别为 77.9 ± 11.8、71.3 ± 19.2 和 82.6 ± 14.7。中位总生存期和无进展生存期分别为 23.1 个月和 14.1 个月。 总之，GBM 特异性荧光 IRDye800-BBN 可以帮助神经外科医生灵敏度和特异性地识别肿瘤边界，并可能改善生存结果。