Safety and Diagnostic Performance of 99mTc-3PRGD2 SPECT/CT in Esophagus Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Visual Assessment of Esophagus Lesions in 99mTc-3PRGD2 SPECT/CT Scan
研究概览
简要总结
This is an open-label single photon emission computed tomography / computed tomography (SPECT/CT) study to investigate the safety and diagnostic performance of 99mTc-HYNIC-3PEG4-E[c(RGDfK)2) (99mTc-3PRGD2) in esophagus cancer patients. A single dose of nearly 11.1 MBq/kg body weight of 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the patients in suspicion of esophagus cancer. Visual and semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT images. Any adverse events will be collected from the patients.
详细描述
Integrin αvβ3 is an important member of integrin receptor family and expressed preferentially on the activated endothelial cells of angiogenesis and some types of tumor cells, but not or very low on the quiescent vessel cells and other normal cells. Therefore, the integrin αvβ3 receptor is becoming a valuable target for diagnosis and response evaluation of malignant tumors.
The tri-peptide sequence of arginine-glycine-aspartic acid (RGD) can specifically bind to the integrin αvβ3 receptor. Accordingly, a variety of radiolabeled RGD-based peptides have been developed for non-invasive imaging of integrin αvβ3 expression via single photon emission computed tomography (SPECT)or positron emission tomography (PET). Among all the RGD radiotracers studied, several RGD monomers have been investigated in clinical trials, and the preliminary results demonstrated specific imaging of various types of tumors, and the tumor uptake correlated well with the level of integrin αvβ3 expression. Recently, several RGD dimeric peptides with PEG linkers have been studied. The new types of RGD peptides showed much higher in vitro integrin αvβ3-binding affinity than the single RGD tri-peptide sequence, and importantly, they exhibited significantly increased tumor uptake and improved in vivo kinetics in animal models. As a representative, 99mTc-3PRGD2 could be easily prepared and exhibited excellent in vivo behaviors in animal models. No adverse reactions are observed in animal models to date.
For the further interests in clinical translation of 99mTc-3PRGD2, an open-label SPECT/CT study was designed to investigate the safety and diagnostic performance of 99mTc-3PRGD2 in esophagus cancer patients. A single dose of nearly 11.1 MBq/kg body weight 99mTc-3PRGD2 ( ≤ 20 µg 3PRGD2) will be intravenously injected into the esophagus cancer patients. Visual and semiquantitative method will be used to assess the whole-body planar and thoracic SPECT/CT images. Adverse events will also be observed in the patients.
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
- 30 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, ≥30 years old
- •Thoracic CT and/or gastroscopy diagnosis in suspicion of primary or recurrent lung cancer.
- •The lung cancer will be histologically confirmed or results of histology 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
Esophagus Cancer, 99mTc-3PRGD2, SPECT/CT
Determine if 99mTc-3PRGD2 SPECT/CT is safe and effective in diagnosis of Esophagus cancer patients.
干预措施: 99mTc-3PRGD2 (Drug)
结局指标
主要结局
Visual Assessment of Esophagus Lesions in 99mTc-3PRGD2 SPECT/CT Scan
时间窗: one year
Visual analysis will be performed by 3 experienced nuclear medicine physicians to observe the the uptake of 99mTc-3PRGD2 on esophagus lesions. The visual analysis interpreter's degree of suspicion for an abnormality was recorded with use of a 3-point with the following categories: score 1, no abnormal increased uptake; score 2, mildly increased uptake; score 3, definite focal increased uptake. The lesion was considered positive as malignancy if the lesion scored as 2 or higher.
Semiquantitative Assessment of Esophagus Lesions in 99mTc-3PRGD2 SPECT/CT Scan
时间窗: one year
The semiquantitative analysis of the standardized uptake values (SUV) of 99mTc-3PRGD2 SPECT/CT was performed on esophagus lesion
次要结局
- 18F-FDG PET/CT Scan(one year)
- Laboratory Values(one year)
- Adverse events collection(5 days)
- Contrast-enhanced CT(one year)
研究者
Weibing Miao, PhD
PhD
First Affiliated Hospital of Fujian Medical University