Abstract LB-025: Fluorescence-guided surgery using the fluorescence in near-infrared II window of indocyanine green for resection of glioma: A randomized controlled trial
Authors: Hu Zhenhua , Shi Xiaojing , Zhang Zhe , Zhang Zeyu , Cao Caiguang , Ji Nan , Tian Jie 
Published: September 2020

Abstract
Introduction: In this study, near-infrared II (NIR-II) fluorescence imaging was presented and used for glioma resection surgery to assist the surgeons to identify the tumor intraoperatively and guide the resection of residual tumor tissue. Methods: 66 patients aged 18-74 years with gliomas diagnosed by contrast MRI were enrolled in the controlled trial and divided into experimental group and control group respectively. For the experiment group, a multispectral fluorescence imaging instrument comprised visible imaging, NIR-I and NIR-II fluorescence imaging sub-system was specially constructed for image-guided resection surgery of gliomas. Patients in the group (n=34) were administered with the Food and Drug Administration (FDA) approved indocyanine green (ICG) intravenously 48h before anesthesia started. During the surgery, visible and NIR-II and NIR-I fluorescence images were acquired by the instrument, and NIR-II fluorescence imaging was applied for image-guided tumor resection in the experimental group. Resected tissue samples were also imaged. Judgement by the surgeon and by fluorescence image were recorded and compared. The pathology was used as the gold standard. For patients in the control group, normal surgery procedure was administered. Postoperative MRI was conducted within 3 days after surgery. The proportion of gross total resection (GTR) assessed by postoperative MRI for patients in both of the group were compared as the primary endpoint. The second endpoint was postoperative neurological status. The neurological status of the patients was assessed by karnofsky performance scale (KPS) and National Institute of Health Stroke Scale (NIHSS). Results: 28 patients in the experimental group had obvious fluorescence of tumor and assigned image-guided surgery. The gliomas were resected completely in 24 of the 28 patients underwent image-guided surgery. In 31 patients of the control group, 20 acquired GTR. The GTR proportion of the experiment group was higher than that of the control group (85.7% vs. 64.5%). There is no significant difference between the evaluation of neuro functions acquired pre and 3 months' post-operation, indicating that fluorescence image-guided surgery did no damage to the neuro function of the patients. As for the sample judgment, the NIR-II fluorescence imaging demonstrated better performance than NIR-I image and surgeons' judgment under white light. NIR-II fluorescence imaging has significantly higher sensitivity and negative predictive value (NPV) than NIR-I. Compared with surgeons' judgment under white light, NIR-II fluorescence has significantly higher sensitivity, NPV and accuracy. Conclusion: This study demonstrated the feasibility of NIR-II fluorescence image-guided surgery being applied in glioma resection surgery. With the guidance of NIR-II fluorescence image, the GTR proportion was improved without damaging the neurological status. Besides, NIR-II fluorescence imaging also performed better than NIR-I image and surgeons' judgment under white light in sample judgment. The results showed great clinical benefits of NIR-II fluorescence image-guided glioma resection surgery.
Citation Format: Zhenhua Hu, Xiaojing Shi, Zhe Zhang, Zeyu Zhang, Caiguang Cao, Nan Ji, Jie Tian. Fluorescence-guided surgery using the fluorescence in near-infrared II window of indocyanine green for resection of glioma: A randomized controlled trial [abstract]. In: Proceedings of the Annual Meeting of the American Association for Cancer Research 2020; 2020 Apr 27-28 and Jun 22-24. Philadelphia (PA): AACR; Cancer Res 2020;80(16 Suppl):Abstract nr LB-025.