Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Tumor detection rate
研究概览
简要总结
The purpose of this study is to determine the pharmacokinetics, dosimetry, tolerance, tumor detection rate of 68Ga-PSMA-33 in patient with Prostate Cancer (PCa).
详细描述
This study is design to prospectively investigate the safety and efficacy of 68Ga-PSMA-33 in the early diagnosis of Prostate Cancer (PCa). The specific objectives are the determination of pharmacokinetics, dosimetry, tolerance and tumor detection rate of 68Ga-PSMA-33 in patient with PCa. While PSMA is expressed at low levels in normal prostate epithelium, it is overexpressed (up to 1000 times higher) in 90-95% of prostate cancers, make PSMA an attractive target for the diagnosis and treatment of PCa. 68Ga-PSMA-33 as a new PSMA targeted probe was prepared and showed good uptake on PCa cell line and animal studies.
The study intends to recruit 8 PCa volunteers to participate in the experiment. All patients were intravenously injected with 68Ga-PSMA-33 and underwent PET/CT at 0.5, 1, 2 and 4 h, respectively. For comparison, 3 patients were additionally received 68Ga-PSMA-617 PET/CT imaging. The images were interpreted by two experienced physician and the SUVmax or SUVmean of physiological organs and tumor lesions were collected.
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 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Age 18 years or older
- •Patients must have histologically or cytologically confirmed localized or metastatic prostate cancer
- •Creatinine less than or equal to 1.5 X upper limit of normal
- •ECOG performance status 0 - 2, inclusive
- •Able to tolerate the physical/logistical requirements of a PET/CT scan including lying supine (or prone) for up to 30 minutes and tolerating intravenous cannulation Patient with complete clinical data.
- •The effects of 68Ga-PSMA-33 on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation.
- •Able to understand and provide written informed consent
排除标准
- •Patient age < 18 years
- •Received radioisotope diagnosis or treatment before enrollment, and the time window did not exceed 10 physical half-lives
- •Malignancy other than current disease under study
- •Patient simultaneously participating in another clinical trial
- •Patient who cannot stay on PET/CT
- •Patient with HIV, HCV, HVB infection or other serious chronic infection
- •Patient with liver and kidney function (GFR less than 50 ml/min) disease
- •Cannot receive furosemide, allergy to sulfa or sulfa-containing medications
- •Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
研究组 & 干预措施
68Ga-PSMA-33
For the injection, subjects will receive a target dose of 3-7mCi 68Ga-PSMA-33 as a bolus injection. Among them, 3~4 subjects will additionally inject with 68Ga-PSMA-617 (3-7mCi).
干预措施: 68Ga-PSMA-33 (Drug)
结局指标
主要结局
Tumor detection rate
时间窗: 2 years
Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
Standardized uptake value (SUV) of tumor
时间窗: 2 years
Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
次要结局
- Safety and Tolerability Profile Measured by Adverse Events (AEs)(2 years)
研究者
FengWang
Professor
Nanjing First Hospital, Nanjing Medical University