This study evaluates the diagnostic performance and safety of 68Ga-NYM032 PET/CT imaging in patients with suspected recurrence of prostate cancer.
Patient is male and aged >18 years old.
Post-radical prostatectomy (RP): PSA ≥0.2 ng/mL on two consecutive measurements obtained ≥6 weeks after surgery;
Post-radiotherapy (as defined by the ASTRO-Phoenix consensus): PSA rise ≥2 ng/mL above the PSA nadir;
Participants with recurrence after other treatments: PSA rise ≥2 ng/mL above the PSA nadir.
Participants who have previously participated in other interventional clinical trials and are within five physical half-lives, or have received radionuclide agents previously with an interval of less than ten physical half-lives prior to study drug injection.
Participants administered any IV iodinated contrast medium within 24 hours, or any high density oral contrast medium (oral water contrast is acceptable) within 5 days, prior to study drug injection.
Known hypersensitivity to the active ingredient or excipients of the study drug.
Participants not capable of getting PET study , or inability to lay still for the duration of the exam.
Single group
68-Ga-NYM032
Diagnostic testIV injection
PPV
Positive predictive value (PPV)were calculated on a per-patient basis on 68Ga-NYM032 PET/CT for detection of tumor location confirmed by the composite truth standard.
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