肿瘤发光术在胸膜切除术和剥脱术中识别残留疾病的临床试验。
A Clinical Trial of TumorGlow to Identify Residual Disease During Pleurectomy and Decortication.
机构信息
Center for Precision Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania; Department of Surgery, Perelman School of Medicine at the University of Pennsylvania, Philadelphia, Pennsylvania.
Department of Surgery, University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania.
出版信息
Ann Thorac Surg. 2019 Jan;107(1):224-232. doi: 10.1016/j.athoracsur.2018.06.015. Epub 2018 Jul 17.
BACKGROUND
Macroscopic complete resection can improve survival in a select group of patients with malignant pleural mesothelioma. During resection, differentiating residual tumor from inflammation or scar can be challenging. This trial evaluated near-infrared (NIR) intraoperative imaging using TumorGlow (a novel NIR imaging approach utilizing high-dose indocyanine green and delayed imaging) technology to improve detection of macroscopic residual disease.
METHODS
Twenty subjects were enrolled in an open-label clinical trial of NIR intraoperative imaging with TumorGlow (Indocyanine Green for Solid Tumors [NCT02280954]). Twenty-four hours before pleural biopsy or pleurectomy and decortication (P/D), patients received intravenous indocyanine green. All specimens identified during standard-of-care surgical resection and with NIR imaging underwent histopathologic profiling and correlative microscopic fluorescent tomographic evaluation. For subjects undergoing P/D (n = 13), the hemithorax was evaluated with NIR imaging during P/D to assess for residual disease. When possible, additional fluorescent lesions were resected.
RESULTS
Of 203 resected specimens submitted for evaluation, indocyanine green accumulated within 113 of 113 of resected mesothelioma specimens, with a mean signal-to-background fluorescence ratio of 3.1 (SD, 2.2 to 4.8). The mean signal-to-background fluorescence ratio of benign tissues was 2.2 (SD, 1.4 to 2.4), which was significantly lower than in malignant specimens (p = 0.001). NIR imaging identified occult macroscopic residual disease in 10 of 13 subjects. A median of 5.6 resectable residual deposits per patient (range, 0 to 11 deposits per patient), with a mean size of 0.3 cm (range, 0.1 to 1.5 cm), were identified.
CONCLUSIONS
TumorGlow for malignant pleural mesothelioma is safe and feasible. Excellent sensitivity allows for to reliable detection of macroscopic residual disease during cytoreductive surgical procedures.
背景
在选择的恶性胸膜间皮瘤患者群体中，完全切除肉眼可见肿瘤可提高生存率。在切除过程中，区分残留肿瘤与炎症或疤痕可能具有挑战性。本试验评估了近红外（NIR）术中成像技术，该技术使用 TumorGlow（一种利用高剂量吲哚菁绿和延迟成像的新型 NIR 成像方法）来提高对肉眼可见残留疾病的检测。
方法
24 名患者参加了 NIR 术中成像技术（TumorGlow）的开放性临床试验（Indocyanine Green for Solid Tumors [NCT02280954]）。在胸膜活检或胸膜切除术和剥脱术（P/D）前 24 小时，患者接受静脉注射吲哚菁绿。在标准手术切除和 NIR 成像过程中发现的所有标本均进行了组织病理学分析，并进行了相关的显微镜荧光断层扫描评估。对于接受 P/D 的患者（n=13），在 P/D 期间对胸腔进行 NIR 成像评估，以评估残留疾病。如果可能，切除更多的荧光病变。
结果
在提交评估的 203 个切除标本中，有 113 个切除的间皮瘤标本中累积了吲哚菁绿，平均信号与背景荧光比值为 3.1（标准差，2.2 至 4.8）。良性组织的平均信号与背景荧光比值为 2.2（标准差，1.4 至 2.4），明显低于恶性标本（p=0.001）。NIR 成像在 13 名患者中的 10 名患者中发现了隐匿性肉眼可见的残留疾病。每个患者可切除的残留沉积物中位数为 5.6 个（范围，每个患者 0 至 11 个沉积物），平均大小为 0.3cm（范围，0.1 至 1.5cm）。
结论
TumorGlow 用于恶性胸膜间皮瘤是安全且可行的。出色的灵敏度可确保在细胞减灭性手术过程中可靠地检测肉眼可见的残留疾病。
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