Limportanza del Data Manager nella stesura, approvazione e gestione dello studio:"Pilot Clinical Study of 64Cu(II)CI2: Efficacy and Safety of a new PET tracer for Urologic Tumors"

AIM To evaluate safety and efficacy of Copper-64(II)Dichloride (Cu-64(II)Cl2) as a new PET tracer for Urological Malignancies (UM). MATERIALS AND METHODS Patients with UM were enrolled in a prospective study. All patients were staged with preoperative CT and Cu-64(II)Cl2-PET/CT. Patient characteristics, anatomical and functional imaging, final histopathology were recorded. Surgical specimens for histopathological examination were collected. To determine time–activity curves for Cu-64(II)Cl2 uptake in UM and normal tissues, standardized uptake values (SUVs) were calculated. The safety of Cu-64(II)Cl2 was assessed. RESULTS 23 patients were included. An administered activity of 174.7MBq (4.72mCi) for Cu-64(II)Cl2 was equal to 9.80mSv of the effective dose. The median SUVmax were 5.7, 0.9, 1.8 and 9.8 for the prostate, bladder, penis and kidney, respectively. Median SUVmax were higher in organs with a malignancy in comparison with healthy tissue [prostate (11.5 vs 5.3,p