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临床试验/NCT03407781
NCT03407781已完成1 期

IRDye800CW-BBN PET-NIRF in Lower Grade Glioma

Deling Li1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2016年1月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
52
试验地点
1
主要终点
Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of lower grade gliomas

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 patients with lower grade glioma. A single dose of 40μg/111-148 Mega-Becquerel (MBq) 68Ga-NOTA-BBN and 1.0- or 2.0- mg/ml IRDye800CW-BBN 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

Lower grade gliomas (WHO grades II and III) are currently diffused disease with variability of tumor behaviors and of challenge to distinguish the margins in white-light microscope during the surgery. An integrated dual-modality approach combining preoperative positron emission tomography imaging with intraoperative optical guidance that target the same tumor biomarker would be of grade help to solve this problem. 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 glioma. For interests in clinical translation of GRPR targeting dual modality probe, an open label dual modality imaging PET/ NIRF study was designed to investigate the imaging guiding performance in lower grade glioma patients. To investigate whether the preoperative PET with BBN can predict the success of the fluorescence guided surgery with same peptide intraoperatively. The sensitivity, specificity and accuracy of fluorescence guided sampling intraoperatively according to the final pathology will be assessed as well.

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

入选标准

  • Must be able to provide a written informed consent
  • suspected lower grade gliomas on contrast-enhanced MRI

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 or PET/MRI scanning
  • Pregnancy or breast feeding

研究组 & 干预措施

68Ga-BBN-IRDye800CW PET/NIRF

Experimental

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 or 2.0 mg/ml BBN-IRDye800CW injected intravenously for near-infrared (NIR) fluorescent imaging-guided surgery.

干预措施: 68Ga-BBN-IRDye800CW (Drug)

结局指标

主要结局

Standardized uptake value of 68Ga-BBN-IRDye800CW in PET imaging of lower grade gliomas

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 lower grade glioma will be measured.

次要结局

  • The sensitivity and specificity of intraoperative IRDye800CW-BBN fluorescence(1 year)

研究者

发起方
Deling Li
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Deling Li

Vice Chair of Brain Tumor Ward 2, associate professor

Beijing Tiantan Hospital

研究点 (1)

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