SPECT Imaging of EpCAM Receptors Using [99mTc]Tc(CO)3-(HE)3-Ec1 in Solid Tumors Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- SPECT-based [99mTc]Tc(CO)3-(HE)3-Ec1 value in tumor lesions (counts)
研究概览
简要总结
The study should evaluate the biological distribution of [99mTc]Tc(CO)3-(HE)3-Ec1 in patients with solid tumor
The primary objective are:
- To assess the distribution of [99mTc]Tc(CO)3-(HE)3-Ec1 in normal tissues and tumors at different time intervals.
- To evaluate dosimetry of [99mTc]Tc(CO)3-(HE)3-Ec1 .
- To study the safety and tolerability of the drug [99mTc]Tc(CO)3-(HE)3-Ec1 after a single injection in a diagnostic dosage.
The secondary objective are:
1. To compare the obtained [99mTc]Tc(CO)3-(HE)3-Ec1 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in solid tumor patients.
详细描述
The overall goal is to study the effectiveness of SPECT imaging solid tumor patients using [99mTc]Tc(CO)3-(HE)3-Ec1.
Phase I of the study:
Biodistribution of [99mTc]Tc(CO)3-(HE)3-Ec1 in patients with solid tumor.
The main objectives of the study:
- To evaluate the distribution of [99mTc]Tc(CO)3-(HE)3-Ec1 in normal tissues and tumors in patients with solid tumor at different time intervals.
- To evaluate dosimetry of [99mTc]Tc(CO)3-(HE)3-Ec1 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]Tc(CO)3-(HE)3-Ec1 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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subject is > 18 years of age
- •Clinical and radiological diagnosis of solid tumor with histological verification.
- •White blood cell count: > 2.0 x 10^9/L
- •Haemoglobin: > 80 g/L
- •Platelets: > 50.0 x 10^9/L
- •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
- •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
[99mTc]Tc(CO)3-(HE)3-Ec1 1000 μg
At least five (5) evaluable subjects with solid tumor.
干预措施: Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1 (Drug)
[99mTc]Tc(CO)3-(HE)3-Ec1 2000 μg
At least five (5) evaluable subjects with solid tumor.
干预措施: Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1 (Drug)
[99mTc]Tc(CO)3-(HE)3-Ec1 3000 μg
At least five (5) evaluable subjects with solid tumor.
干预措施: Diagnostic Test: whole body study and SPECT with [99mTc]Tc(CO)3-(HE)3-Ec1 (Drug)
结局指标
主要结局
SPECT-based [99mTc]Tc(CO)3-(HE)3-Ec1 value in tumor lesions (counts)
时间窗: 6 hours
\[99mTc\]Tc(CO)3-(HE)3-Ec1 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
Gamma camera-based whole-body [99mTc]Tc(CO)3-(HE)3-Ec1 uptake value (%)
时间窗: 24 hours
Whole-body \[99mTc\]Tc(CO)3-(HE)3-Ec1 uptake coinciding with normal organs and tissues will be assessed using gamma camera and calculated as percentage (%) of the injected dose of the radiopharmaceutical
SPECT-based [99mTc]Tc(CO)3-(HE)3-Ec1 uptake value (counts)
时间窗: 6 hours
Focal uptake of \[99mTc\]Tc(CO)3-(HE)3-Ec1 in the regions without pathological findings will be assessed with SPECT and measured in counts
Tumor-to-background ratio (SPECT)
时间窗: 6 hours
The SPECT-based tumor-to-background ratio will be calculated as follows: the value of \[99mTc\]Tc(CO)3-(HE)3-Ec1 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc(CO)3-(HE)3-Ec1 uptake coinciding with the regions without pathological findings (counts)
次要结局
- Incidence and severity of adverse events associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections(24 hours)
- Percent of cases with abnormal findings in physical examination, vital signs, and ECG associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections(24 hours)
- Percent of cases with abnormal laboratory test results associated with [99mTc]Tc(CO)3-(HE)3-Ec1 injections(24 hours)
- Percent of cases requiring administration of concomitant medication due to [99mTc]Tc(CO)3-(HE)3-Ec1 injections(24 hours)