Prospective Clinical Study of 18F-mFBG PET Imaging in Neuroblastoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Diagnostic efficacy
研究概览
简要总结
The aim of this study is to evaluate the diagnostic performance and tumor burden of 18F-metafluorobenzylguanidine (18F-MFBG) positron emission tomography (PET) in patients with neuroblastoma.
详细描述
Neuroblastoma highly expresses norepinephrine transporter (NET) which is targeted by function alanalogue of norepinephrine, 123/131I-MlBG. However, low spatial resolution of 123/131I-MlBG and inaccurate attenuation correction of single photon emission tomography (SPECT/CT) will affect the image quality of MlBG SPECT and lead to poor diagnosis of small lesions. In addition, 123l-MlBG imaging is usually performed at 24h after injection, while 131I-MlBG is performed at 48h or even 72h after injection. The procedure is complicated and takes a long time, which limits clinical application. 18F-labeled MFBG is an ideal tracer to show the expression of NET. Preliminary data show that 18F-MFBG imaging is safe and has favorable biodistribution and kinetics with good targeting of lesions. Patients can undergo PET 0.5 hours after injection without special preparation. Our study will assess the safety profile, image quality and evaluate the diagnostic performance and tumor burden of 18F-MFBG. Patients with suspected or histologically confirmed neuroblastoma will be enrolled in this study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 0-18 years old, with legal guardian;
- •Clinically suspected or confirmed patients with neuroblastoma;
- •If the patient is under 8 years old or unable to write, his/her guardian should understand and comply with the requirements of the study. If the patient is 8 years old or older and has written ability, both the patient and his/her guardian must sign the informed consent.
排除标准
- •Patients with severe primary diseases such as heart, brain, liver, kidney and hematopoietic system diseases;
- •Patients who have received ionizing radiation outside the scope of this experiment for other clinical medical or scientific research purposes within the past year, resulting in an annual radiation exposure dose exceeding 50 mSv.
- •Patients who have received experimental drugs or devices (with uncertain efficacy or safety) within one month;
- •Patients with any condition that the principal investigator of this study deems may cause harm or potential harm in any aspect related to this trial.
研究组 & 干预措施
18F-MFBG PET/CT in Neuroblastoma
Each patient receive a single intravenous injection of 18F-MFBG 2-5 MBq/kg and undergo PET/CT or PET/MR scan after 60 min post-injection.
干预措施: 18F-MFBG (Drug)
结局指标
主要结局
Diagnostic efficacy
时间窗: through study completion, an average of 1.5 year
Sensitivity, specificity, positive and negative predictive value of 18F-mFBG PET/CT and PET/MR Imaging in neuroblastoma
次要结局
- 18F-mFBG PET performence compared with other images(up to 24 months)
- Prognostic Value of Baseline 18F-mFBG PET for Progression-Free Survival (PFS) in High-Risk Patients(through study completion, 3-4 years)