Molecular Imaging of Brain Tumor Using 99mTc-1-thio-D-glucose SPECT/CT and 18F-Fluoroethyl-l-tyrosine PET/CT in Primary and Recurrent Glioma Patients
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- 99mTc-1-thio-D-glucose uptake in tumor (SUVmean)
研究概览
简要总结
An open-label, single-center study with 99mTc-1-thio-D-glucose single photon emission computed tomography / computed tomography (SPECT/CT) and 18F-fluoroethyl-l-tyrosine (18F-FET) positron emission tomography / computed tomography (PET/CT) in primary and recurrent glioma patients, where the primary endpoint of the study is to compare imaging properties of 99mTc-1-thio-D-glucose SPECT/CT and 18F-FET PET/CT of brain tumor Imaging.
详细描述
The primary objectives are:
- To compare 99mTc-1-thio-D-glucose SPECT/CT and 18F-FET PET/CT properties in primary and recurrent glioma patients
The secondary objectives are:
- To compare the accumulation levels of 99mTc-1-thio-D-glucose and 18F-FET depending on the pathomorphological (biopsy/surgical material) and molecular genetic (Ki-67, isocitrate dehydrogenase 1/2 (IDH1/2) mutations, p53 expression) characteristics of the tumor.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of primary and recurrent glioma;
- •Sequential injection of 99mTc-1-thio-D-glucose and 18F-FET in the interval of 14 days in each patient;
- •Hematological, liver and renal function test results within the following limits:
- •White blood cell count: > 2.0 x 109/L
- •Hemoglobin: > 80 g/L
- •Platelets: > 50.0 x 109/L
- •Alanine aminotransferase (ALT), alkaline phosphatase (ALP), aspartate aminotransferase (AST): =< 5.0 times Upper Limit of Normal
- •Bilirubin =< 2.0 times Upper Limit of Normal
- •Serum creatinine: Within Normal Limits
- •A negative pregnancy test for all patients of childbearing potential. Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception for at least 30 days after study termination;
- •Subject is capable to undergo the diagnostic investigations to be performed in the study;
- •Informed consent.
排除标准
- •Second, non-brain malignancy;
- •Active current autoimmune disease or history of autoimmune disease;
- •Active infection or history of severe infection within the previous 3 months (if clinically relevant at screening);
- •Known HIV positive or chronically active hepatitis B or C;
- •Administration of other investigational medicinal product within 30 days of screening;
- •Ongoing toxicity > grade 2 from previous standard or investigational therapies, according to US National Cancer Institute's.
研究组 & 干预措施
Primary and recurrent glioma patients.
Maximum (40) evaluable subjects with primary and recurrent glioma have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced
干预措施: 99mTc-1-thio-D-glucose (Drug)
Primary and recurrent glioma patients.
Maximum (40) evaluable subjects with primary and recurrent glioma have to be enrolled in the study. Subjects withdrawn from the study for any reason will be replaced
干预措施: 18F-FET (Drug)
结局指标
主要结局
99mTc-1-thio-D-glucose uptake in tumor (SUVmean)
时间窗: 1 hour
SPECT/CT-based 99mTc-1-thio-D-glucose uptake value in primary or recurrent tumor lesions will be assessed at 1 hour after injection and measured in SUVmean.
99mTc-1-thio-D-glucose tumor-to-background ratio (SPECT/CT)
时间窗: 1 hour
The SPECT/CT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-1-thio-D-glucose uptake coinciding with tumor lesions (SUVmean) will be divided by the value of 99mTc-1-thio-D-glucose uptake coinciding with the brain regions without pathological findings (SUVmean).
18F-FET uptake in tumor (SUVmean)
时间窗: 20 minutes
PET/CT-based 18F-FET uptake value in primary tumor lesions or in recurrent tumor lesions will be assessed at 20 minutes after injection and measured in SUVmean.
18F-FET tumor-to-background ratio (PET/CT)
时间窗: 20 minutes
The PET/CT-based tumor-to-background ratio will be calculated as follows: the value of 18F-FET uptake coinciding with tumor lesions (SUVmean) will be divided by the value of 18F-FET uptake coinciding with the brain regions without pathological findings (SUVmean).
Sensitivity of 99mTc-1-thio-D-glucose SPECT/CT (%)
时间窗: 1 hour
Sensitivity (%) of the 99mTc-1-thio-D-glucose SPECT/CT will be assessed by comparing of cases with high 99mTc-1-thio-D-glucose uptake in the primary tumor with the positive for glioma results of immunohistochemical studies.
99mTc-1-thio-D-glucose uptake in background (SUVmean)
时间窗: 1 hour
SPECT/CT-based 99mTc-1-thio-D-glucose uptake value in normal brain tissue will be assessed at 1 hour after injection and measured in SUVmean.
18F-FET uptake in background (SUVmean)
时间窗: 20 minutes
PET/CT-based 18F-FET uptake value in normal brain tissue will be assessed at 20 minutes after injection and measured in SUVmean.
Sensitivity of 18F-FET PET/CT (%)
时间窗: 20 minutes
Sensitivity (%) of the 18F-FET PET/CT will be assessed by comparing of cases with high 18F-FET uptake in the primary tumor with the positive for glioma results of immunohistochemical studies.
次要结局
未报告次要终点