Status:
UNKNOWN
Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
Lead Sponsor:
Nanjing First Hospital, Nanjing Medical University
Conditions:
Prostate Cancer
Eligibility:
MALE
18-99 years
Phase:
NA
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 pharmacokine...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2024
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT06054789
Start Date
October 1 2022
End Date
October 1 2024
Last Update
September 26 2023
Active Locations (1)
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1
68Ga-PSMA-33 PET/CT imaging
Nanjing, Jiangsu, China, 210006