Safety and Diagnostic Performance of 68Gallium-labeled NOTA-Aca-BBN(7-14) PET/CT in Patients With Primary Gliomas
试验速览
- 阶段
- 早期 1 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Standardized uptake value of 68Ga-NOTA-Aca-BBN(7-14) in primary glioma
研究概览
简要总结
This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the diagnostic performance and evaluation efficacy of 68Ga-NOTA-Aca-BBN(7-14) in glioma patients. A single dose of 111-148 Mega-Becquerel (MBq) 68Ga-NOTA-Aca-BBN(7-14) will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.
详细描述
Non-invasive imaging evaluation of GRPR expression would be of great help in drug development, patient stratification and therapeutic response monitoring. Various GRPR targeting imaging probes have been develop to meet the purpose. Bombesin (BBN) is an amphibian homolog of mammalian gastrin-releasing peptide (GRP). BBN(7-14), 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), after being labeled with various radionuclides. Multiple preclinical studies have demonstrated receptor-specific accumulation of the tracers in GRPR positive tumors. For interests in clinical translation of 68Ga-NOTA-Aca-BBN(7-14), an open-label dynamic whole-body PET/ CT study was designed to investigate the safety and diagnostic performance of 68Ga-NOTA-Aca-BBN(7-14) in patients with glioma.
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
- 3 Years 至 70 Years（Child, 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
- •Clinically based and magnetic resonance imaging (MRI)-based suspected newly diagnosed primary glioma.
- •The tumor will be surgically removed and histological diagnosis will be available.
排除标准
- •Females planning to bear a child recently or with childbearing potential；
- •Known severe allergy or hypersensitivity to IV radiographic contrast；
- •Inability to lie still for the entire imaging time because of cough, pain, etc.
- •Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc.
- •Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
研究组 & 干预措施
68Ga-NOTA-Aca-BBN(7-14) PET/CT
The patients were injected with 111-148 MBq of 68Ga-NOTA-Aca-BBN(7-14) in one dose intravenously and underwent PET/CT scan 30 min later.
干预措施: PET/CT (Device)
68Ga-NOTA-Aca-BBN(7-14) PET/CT
The patients were injected with 111-148 MBq of 68Ga-NOTA-Aca-BBN(7-14) in one dose intravenously and underwent PET/CT scan 30 min later.
干预措施: 68Ga-NOTA-Aca-BBN (Drug)
结局指标
主要结局
Standardized uptake value of 68Ga-NOTA-Aca-BBN(7-14) in primary glioma
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 primary glioma will be measured.
次要结局
- Adverse events collection(1 week)