Clinical Study on 68Ga-PSMA-33 for PET/CT Imaging of Prostate Cancer
Prostate Cancer
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate-Specific Membrane Antigen (PSMA), PET/CT, Prostate cancer
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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
Sites / Locations
- 68Ga-PSMA-33 PET/CT imagingRecruiting
Arms of the Study
Arm 1
Experimental
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).