Gallium-68 Labelled THP-PSMA for the Clinical Stage and Restage of Prostate Cancer Patients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- The maximal standard uptake value
研究概览
简要总结
To evaluate the dosimetry, safety and the detection rate of 68Ga-THP-PSMA PET/CT for identifying the site of prostate cancer metastasis and relapse. It is also to evaluate the association of clinical/pathologic features and 68Ga-THP-PSMA PET/CT detection rate and compare 68Ga-THP-PSMA PET/CT with other imaging procedure.
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 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Adult male, age 18 years or older
- •Prior diagnosis of prostatic cancer
- •Willing to participate in this study and given written informed consent
- •AST, ALT, BUN, Cr not more than double the normal values
- •Subjects of childbearing potential must be willing to undergo a pregnancy test prior to enrolment
排除标准
- •Subjects with pacemakers
- •Hepatitis B virus infection (including carriers) at screening, i.e. hepatitis B surface antigen (HBsAg) positive, or hepatitis C antibody (anti-HCV) positive, or acquired immunodeficiency disease (HIV) infected, or serum syphilis positive person
- •Abnormal liver function during baseline screening period: AST or ALT> 2 times the upper limit of normal value (ULN), if the marginal increase of a single index is judged as having no clinical significance by the investigator, it can be retested during the screening period. Once, if more than 2 times ULN after retesting, consider enrolling).
- •Impaired renal function during screening: serum creatinine or urea nitrogen > 1.5 times ULN.
- •Within 4 months prior to the baseline screening period, myocardial infarction or other cardiac events requiring hospitalization (unstable angina, etc.), cerebrovascular accident, transient ischemic attack, acute congestive Heart failure or severe arrhythmia (ventricular arrhythmia, atrioventricular block above II)
- •Subjects with pulmonary embolism or deep vein thrombosis
- •Various infections that the investigators consider unsuitable for study, including but not limited to patients with various infections requiring further treatment, such as urinary tract infections, respiratory infections, and diabetic foot infections.
- •Patients with abnormal thyroid function during baseline screening period (including but not limited to active hyperthyroidism, hypothyroidism or Hashimoto's thyroiditis)
研究组 & 干预措施
Experimental Arm
All Prostate cancer patients recruited to the study will be administered 2.11 MBq/kg of 68Ga-THP-PSMA in a single dose injection.
干预措施: 68Ga-Labeled PSMA (Drug)
Experimental Arm
All Prostate cancer patients recruited to the study will be administered 2.11 MBq/kg of 68Ga-THP-PSMA in a single dose injection.
干预措施: Non-labeled PSMA (Drug)
结局指标
主要结局
The maximal standard uptake value
时间窗: 2 years
The tumor SUVmax of patients will be measured using Region Of Interest.
The measurement of PSA
时间窗: 2 years
The PSA level (ng/mL) of patients will be tested by hemanalysis
68Ga-THP-PSMA PET/CT in prostate cancer: clinical stage and restage
时间窗: 2 years
Visual analysis will be carried out by 4 experienced nuclear medicine physicians to observe the uptake of 68Ga-THP-PSMA in prostate malignant lesions. A 4 point method will be used to interpret the scans for abnormalities. It is categorized as such: score 0, no abnormal increased uptake; score 1, low increased uptake; score 2, moderate increased uptake; score 3, high increased uptake. The lesion will be considered positive for malignancy if the score is 2 or higher.
次要结局
- The correlation analysis(2 years)
- The dosimetry assessment(2 years)
- The safety evaluation(2 years)
研究者
Zhao Jin Hua, MD
Director Department of Nuclear Medicine, Principal Investigator, Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine