SPECT Imaging of Brain Tumors Using Technetium-99m Labeled 1-Thio-D-Glucose (99mTc-1-thio-D-glucose).
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- SPECT-based 99mTc-1-thio-D-glucose value in tumor lesions (counts)
研究概览
简要总结
The study should evaluate the biological distribution of 99mTc-1-thio-D-glucose in patients with primary brain tumors and recurrence of brain tumors.
The primary objective are:
- To assess the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors at different time intervals.
- To evaluate dosimetry of 99mTc-1-thio-D-glucose.
- To study the safety and tolerability of the drug 99mTc-1-thio-D-glucose after a single injection in a diagnostic dosage.
The secondary objective are:
- To compare the obtained SPECT imaging results of brain tumors with the data of magnetic resonance imaging (MRI) and/or positron emission tomography (PET) and immunohistochemical (IHC) studies of postoperative material.
详细描述
The overall goal is to study the effectiveness of SPECT imaging of primary brain tumors and relapse of brain tumors using technetium-99m labeled glucose.
Phase I of the study:
Biodistribution of 99mTc-1-thio-D-glucose in patients with primary brain tumors and in patients with recurrence of a brain tumor.
The main objectives of the study:
- To evaluate the distribution of 99mTc-1-thio-D-glucose in normal tissues and tumors in patients with brain tumors at different time intervals.
- To evaluate dosimetry 99mTc-1-thio-D-glucose based on the pharmacokinetic parameters of the drug after a single intravenous administration.
- To study the safety of use and tolerability of the drug 99mTc-1-thio-D-glucose after a single intravenous administration in a diagnostic dosage.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Subject is > 18 years of age
- •Clinical and radiological diagnosis of a primary brain tumor or recurrence of a brain tumor with immunohistological verification.
- •Clinical and radiological diagnosis of a benign intracranial lesions.
- •White blood cell count: > 2.0 x 10^9/L
- •Haemoglobin: > 80 g/L
- •Platelets: > 50.0 x 10^9/L
- •alanine amino transferase (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
- •Blood glucose level not more than 5.9 mmol/L
- •A negative pregnancy test (serum beta-human chorionic gonadotropin, beta-HCG) at screening 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 Brain Tumor
The tested injected doses of 99mTc-1-thio-D-glucose 500 megabecquerels (MBq).
At least five (5) evaluable subjects with primary brain tumor. The tested injected dose 500 MBq.
干预措施: SPECT or SPECT-CT with 99mTc-1-thio-D-glucose (Drug)
Recurrence of Brain Tumor
The tested injected doses of 99mTc-1-thio-D-glucose 500 MBq.
At least five (5) evaluable subjects with recurrence of brain tumor. The tested injected dose 500 MBq
干预措施: SPECT or SPECT-CT with 99mTc-1-thio-D-glucose (Drug)
Benign intracranial lesions
The tested injected doses of 99mTc-1-thio-D-glucose 500 MBq.
At least five (5) evaluable subjects with benign intracranial lesions. The tested injected dose 500 MBq
干预措施: SPECT or SPECT-CT with 99mTc-1-thio-D-glucose (Drug)
结局指标
主要结局
SPECT-based 99mTc-1-thio-D-glucose value in tumor lesions (counts)
时间窗: 6 hours
99mTc-1-thio-D-glucose uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
Gamma camera-based whole-body 99mTc-1-thio-D-glucose uptake value (percent)
时间窗: 24 hours
Whole-body 99mTc-1-thio-D-glucose uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (percent) of the injected dose of the radiopharmaceutical
SPECT-based 99mTc-1-thio-D-glucose uptake value (counts)
时间窗: 6 hours
Focal uptake of 99mTc-1-thio-D-glucose in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (unitless value)
时间窗: 6 hours
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of 99mTc-1-thio-D-glucose uptake coinciding with tumor lesions (counts) will be divided by the value of 99mTc-1-thio-D-glucose uptake coinciding with the regions without pathological findings (counts)
次要结局
- Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal laboratory results (percent)(24 hours)
- Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of abnormal physical findings (percent)(24 hours)
- Safety attributable to 99mTc-1-thio-D-glucose injections, based on the rate of adverse events (percent)(24 hours)
- Safety attributable to 99mTc-1-thio-D-glucose injections, based on the need for concomitant medication (percent)(24 hours)