SPECT Imaging of Gastrin Releasing Peptide Receptors Using Labeled Technetium-99m DB8 ([99mTc]Tc- DB8) in Prostate Cancer and Breast 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-DB8 uptake value (%)
研究概览
简要总结
The study should evaluate the biological distribution of 99mTc-DB8 in patients with prostate cancer and breast cancer.
The primary objective are:
- To assess the distribution of [99mTc]Tc- DB8 in normal tissues and tumors at different time intervals.
- To evaluate dosimetry of [99mTc]Tc- DB8.
- To study the safety and tolerability of the drug [99mTc]Tc- DB8 after a single injection in a diagnostic dosage.
The secondary objective are:
1. To compare the obtained [99mTc]Tc- DB8 SPECT imaging results with the data of CT and/or MRI and/or ultrasound examination and immunohistochemical (IHC) studies in prostate cancer and breast cancer patients.
详细描述
The overall goal is to study the effectiveness of SPECT imaging prostate cancer and breast cancer patients Using technetium-99m labeled DB8.
Phase I of the study:
Biodistribution of 99mTc-DB8 in patients with prostate cancer and breast cancer.
The main objectives of the study:
- To evaluate the distribution of 99mTc-DB8 in normal tissues and tumors in patients with prostate cancer and breast cancer at different time intervals.
- To evaluate dosimetry of 99mTc-DB8 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-DB8 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)
盲法说明
Single (Participant)
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
- •Subject is > 18 years of age
- •Clinical and radiological diagnosis of prostate cancer and breast 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
- •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
Breast cancer
At least five (5) evaluable subjects with breast cancer
干预措施: Intravenous injection of [99mTc]Tc-DB8 (Drug)
Prostate cancer
At least five (5) evaluable subjects with prostate cancer
干预措施: Intravenous injection of [99mTc]Tc-DB8 (Drug)
结局指标
主要结局
Gamma camera-based whole-body [99mTc]Tc-DB8 uptake value (%)
时间窗: 24 hours
Whole-body \[99mTc\]Tc-DB8 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-DB8 value in tumor lesions (counts)
时间窗: 6 hours
\[99mTc\]Tc-DB8 uptake coinciding with tumor lesions will be assessed using single-photon emission computed tomography and measured in counts
SPECT-based [99mTc]Tc-DB8 background uptake value (counts)
时间窗: 6 hours
Focal uptake of \[99mTc\]Tc-DB8 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-DB8 uptake coinciding with tumor lesions (counts) will be divided by the value of \[99mTc\]Tc-DB8 uptake coinciding with the regions without pathological findings (counts)
次要结局
- Safety attributable to [99mTc]Tc-DB8 injections (physical findings)(24 hours)
- Safety attributable to [99mTc]Tc-DB8 injections (laboratory tests)(24 hors)
- Safety attributable to [99mTc]Tc-DB8 injections (concomitant medication)(24 hours)
- Safety attributable to [99mTc]Tc-DB8 injections (incidence of adverse events)(24 hours)