RT Journal Article
SR Electronic
T1 <strong>Diagnostic accuracy and survival benefits of first-in-human study of fluorescence-guided surgery with IRDye800-BBN in GBM Patients</strong><strong>Diagnostic accuracy and survival benefits of first-in-human study of fluorescence-guided surgery with IRDye800-BBN in GBM Patients</strong>
JF Journal of Nuclear Medicine
JO J Nucl Med
FD Society of Nuclear Medicine
SP 165
OP 165
VO 61
IS supplement 1
A1 Li, Deling
A1 Chi, Chongwei
A1 Zhang, Jingjing
A1 Tian, Jie
A1 Zhu, Zhaohui
A1 Ji, Nan
A1 Chen, Xiaoyuan
YR 2020
UL http://jnm.snmjournals.org/content/61/supplement_1/165.abstract
AB 165Objectives: To confirm fluorescence-guided surgery with IRDye800-BBN can precisely differentiate the boundary of Glioblastoma Multiform (GBM) intraoperatively and whether this technique can benefit the patients’ overall survival. Methods: The patients with newly-diagnosed and recurrent GBM suspected by preoperative enhancing MRI were enrolled in this trial (NCT02910804). The tumor locations relevant to eloquent brain areas were categorized to grade I, II and III, respectively implicating noneloquent area, near eloquent and involving eloquent areas. IRDye800-BBN was intravenously given to the patients at the dose of 1 mg (in 20mL sterile water) 16 hours before operation. The customized handheld camera with channel 800nm laser was utilized with routine white-light operative microscope in operations. The postoperative enhancing MRI were used to assess the residual tumor volume, calculate the extent of resection and confirm whether complete resection had been achieved. Complete resection was regarded as the residual MRI enhancing tumor foci smaller than 175 mm3. The tumor tissue and nonfluorescent suspected normal brain tissue in nearby noneloquent areas along the fluorescence boundary were harvested for diagnostic accuracy assessment. The patients were followed-up every 3 months until death. Results: Forty-eight GBM patients were enrolled in this trial, including 38 newly-diagnosed and another 10 recurrent. According to the tumors’ locations, there were 22 grade III tumors, 13 grade II tumors and 13 grade II tumors. The mean volumes of the tumors were 43.1 cm3. Among the newly-diagnosed GBM patients, 84.2% (32/38) achieved complete resection, except 6 patients with grade III tumor involving eloquent brain areas. The postoperative enhancing MRI showed that mean (99.0±2.1)% of the preoperative enhancing tumor had been resected. All patients’ Karnofsky Performance Status (KPS) scores were (77.9±11.8), the immediate KPS were (71.3±19.2) and the 6-month postoperative KPS improved to (82.6±14.7). According to the intraoperative fluorescence, 126 samples were harvested, including 103 fluorescence positive and another 23 fluorescence negative samples. The sensitivity and specificity of fluorescence were 95.1% (95% CI 88.5%-98.2%) and 78.3% (95% CI 55.8%-91.7%), respectively. The PPV (positive predictive value) and NPV (negative predictive value) were 95.1% and 78.3%, respectively. Among the 38 newly-diagnosed GBM patients, 25 patients had been followed-up and 14 patients had died. The standard postoperative chemotherapy and radiotherapy were completed in 76% (19/25) of followed-up patients. The median overall survival (OS) was 23.1 months and the median PFS was 14.1 months, which were longer than the 14.6 months in the Stupp trial. The longest OS was more than 36 months and the longest PFS was 23.8 months. The median OS was only 11.4 months among the 4 newly-diagnosed GBM patients without complete resection. Conclusions: The fluorescence-guided surgery with IRDye800-BBN can help neurosurgeon to differentiate the GBM boundary with high sensitivity and specificity. It did not cause any obvious long-term neurofunctional damage. It might benefit to newly-diagnosed GBM patients, which need more robust evidence with further randomized control trial versus clinical routine operation with white-light microscope or other fluorescence dye such as 5-ALA.