Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
- Registration Number
- NCT06054789
- Brief Summary
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).
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 8
- Male sex
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 68Ga-PSMA-33 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).
- Primary Outcome Measures
Name Time Method Tumor detection rate 2 years Comparing the number of tumor detected by 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
Standardized uptake value (SUV) of tumor 2 years Comparing the SUVmax of tumor derived from 68Ga-PSMA-33 and 68Ga-PSMA-617 PET/CT.
- Secondary Outcome Measures
Name Time Method Safety and Tolerability Profile Measured by Adverse Events (AEs) 2 years Safety and tolerability profile for the administration of 68Ga-PSMA-33 and positron emission tomography (PET) scanning are measured by number of participants with adverse events (AEs).
Trial Locations
- Locations (1)
68Ga-PSMA-33 PET/CT imaging
🇨🇳Nanjing, Jiangsu, China