SPECT Imaging of Prostate-Specific Membrane Antigen Using Labeled Technetium-99m BQ0413 ([99mTc]Tc- BQ0413) in Prostate Cancer Patients
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Gamma camera-based whole-body [99mTc]Tc-BQ0413 uptake value (%)
研究概览
简要总结
The study should evaluate the biological distribution of [99mTc]Tc-BQ0413 in patients with prostate cancer.
The primary objective are:
- To assess the distribution of [99mTc]Tc- BQ0413 in normal tissues and tumors at different time intervals.
- To evaluate dosimetry of [99mTc]Tc- BQ0413.
- To study the safety and tolerability of the drug [99mTc]Tc- BQ0413 after a single injection in a diagnostic dosage.
The secondary objective are:
- To compare the obtained [99mTc]Tc- BQ0413 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer patients.
详细描述
The overall goal is to study the effectiveness of SPECT imaging prostate cancer patients Using technetium-99m labeled BQ0413.
Phase I of the study:
Biodistribution of [99mTc]Tc-BQ0413 in patients with prostate cancer.
The main objectives of the study:
- To evaluate the distribution of [99mTc]Tc-BQ0413 in normal tissues and tumors in patients with prostate cancer at different time intervals.
- To evaluate dosimetry of [99mTc]Tc-BQ0413 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-BQ0413 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 75 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject is > 18 years of age
- •Clinical and radiological diagnosis of prostate cancer 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
- •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
Experimental: Prostate cancer 50 mkg
At least five (5) evaluable subjects with prostate cancer with [99mTc]Tc-BQ0413 (50 mkg)
干预措施: Whole body study and SPECT with [99mTc]Tc-BQ0413 (Drug)
Experimental: Prostate cancer 100 mkg
At leaAt least five (5) evaluable subjects with prostate cancer with [99mTc]Tc-BQ0413 (100 mkg)
干预措施: Whole body study and SPECT with [99mTc]Tc-BQ0413 (Drug)
结局指标
主要结局
Gamma camera-based whole-body [99mTc]Tc-BQ0413 uptake value (%)
时间窗: 24 hours
Whole-body \[99mTc\]Tc-BQ0413 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-BQ0413 value in tumor lesions (counts)
时间窗: 6 hours
\[99mTc\]Tc-BQ0413 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based [99mTc]Tc-BQ0413 uptake value (counts)
时间窗: 6 hours
Focal uptake of \[99mTc\]Tc-BQ0413 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-BQ0413 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-BQ0413 uptake coinciding with the regions without pathological findings (counts)
次要结局
- Percent of participants with adverse events that are related to diagnostic imaging procedure [Safety and Tolerability](24 hours)
- Percent of participants requiring administration of medication due to side effects that are related to diagnostic imaging procedure [Safety and Tolerability](24 hours)
- Percent of participants with abnormal laboratory values that are related to diagnostic imaging procedure [Safety and Tolerability](24 hours)
- Percent of cases with abnormal findings relative to baseline [Safety and Tolerability](24 hours)