PET-NIRF Dual Modality Imaging Guiding Surgery in Patients With Glioblastoma
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM
研究概览
简要总结
This is an open-label positron emission tomography/near infrared (PET/NIRF) study to investigate the imaging navigation performance and evaluation efficacy of dual modality imaging probe 68Ga-BBN-IRDye800CW in glioblastoma (GBM) patients. A single dose of 40μg/111-148 Mega-Becquerel (MBq) and 1.0 mg/ml 68Ga-BBN-IRDye800CW will be injected intravenously before the operation and intraoperative respectively. Visual and semiquantitative method will be used to assess the PET images and real-time margins localization for surgical navigation.
详细描述
Non-invasive preoperative PET imaging evaluation and real-time fluorescence-guided surgery would be of great help in GBM patients. BBN, with the amino acid sequence of Gln-Trp-Ala-Val-Gly-His-Leu-Met-NH2, has been extensively used for the development of molecular probes for the imaging of gastrin-releasing peptide receptor (GRPR), a member of the G protein-coupled receptor family of bombesin receptors that over-expressed in various types of cancer cells including glioblastoma multiforme. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIFR study was designed to investigate the safety and imaging guiding performance of 68Ga-BBN-IRDye800CW in patients with GBM.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be able to provide a written informed consent
- •MRI imaging and/or pathological evidence of Newly Diagnosed or recurrence GBM
排除标准
- •Consisted of conditions of mental illness
- •Severe liver or kidney disease with serum creatinine > 3.0 mg/dl (270 μΜ)
- •Any hepatic enzyme level 5 times or more than normal upper limit
- •Severe allergy or hypersensitivity to IV radiographic contrast
- •Claustrophobia to accept the PET/CT scanning
- •Pregnancy or breast feeding
研究组 & 干预措施
68Ga-BBN-IRDye800CW PET/NIRF
The patients were injected with 40μg/111-148 Mega-Becquerel (MBq) 68Ga-BBN-IRDye800CW in one dose intravenously and then underwent PET scan 30 min later before the operation and intraoperative 1.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery.
干预措施: 68Ga-BBN-IRDye800CW (Drug)
68Ga-BBN-IRDye800CW PET/NIRF
The patients were injected with 40μg/111-148 Mega-Becquerel (MBq) 68Ga-BBN-IRDye800CW in one dose intravenously and then underwent PET scan 30 min later before the operation and intraoperative 1.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery.
干预措施: PET/NIRF (Device)
68Ga-BBN-IRDye800CW PET/NIRF
The patients were injected with 40μg/111-148 Mega-Becquerel (MBq) 68Ga-BBN-IRDye800CW in one dose intravenously and then underwent PET scan 30 min later before the operation and intraoperative 1.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery.
干预措施: PET/NIR fluorescent imaging-guided surgery (Procedure)
结局指标
主要结局
Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of GBM
时间窗: 1 year
The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in GBM will be measured.
Margin assessment of positive tumors in NIRF fluorescent-guided surgery
时间窗: 1 year
次要结局
未报告次要终点
研究者
Deling Li
Dr.
Beijing Tiantan Hospital