Efficacy and Safety of the 64Cu(II)Cl2 PET/CT for Urological Malignancies Phase IIa Clinical Study

Purpose of the Report The aim of this study was to evaluate safety and efficacy of copper-64(II)dichloride (Cu-64(II)Cl-2) as a new PET tracer for urological malignancies (UMs). Methods Patients with UM were enrolled in a prospective study. All patients were staged with preoperative CT and Cu-64(II)Cl-2 PET/CT. Patient characteristics, anatomical and functional imaging, and final histopathology were recorded. Surgical specimens for histopathological examination were collected. To determine time-activity curves for Cu-64(II)Cl-2 uptake in UM and normal tissues, SUVs were calculated. The safety of Cu-64(II)Cl-2 was assessed. Results Twenty-three patients were included. An administered activity of 174.7 MBq (4.72 mCi) for Cu-64(II)Cl-2 was equal to 9.80 mSv of the effective dose. The median SUVmax values were 5.7, 0.9, 1.8, and 9.8 for the prostate, bladder, penis, and kidney, respectively. Median SUVmax values were higher in organs with a malignancy in comparison with healthy tissue (prostate [11.5 vs 5.3, P < 0.001], bladder [6.2 vs 0.9, P = 0.007], and penis [3.9 vs 1.3, P = 0.027]), but not in the kidneys (5.0 vs 10.4, P = 0.998). The highest area under the curve (AUC) was reported for prostate cancer (AUC, 0.978), and the lowest for penile cancer (AUC, 0.775). The detection rates based on the best suggested cutoff according to the SUVmax were 85.7% (6/7) for prostate and bladder and 83.3% (5/6) for penile cancer. Neither drug-related effects nor physiologic responses occurred, nor adverse reactions. Conclusions Cu-64(II)Cl-2 is an effective and well-tolerated tracer in patients with UM. Our results show higher SUVmax in cancer patients than in healthy subjects. Our findings suggest that Cu-64(II)Cl-2 PET/CT is useful in patients affected by prostate, bladder, and penis cancer.

Automated summary

This study evaluated the safety and efficacy of Cu-64(II)Cl-2 as a new PET tracer for urological malignancies. The results showed that Cu-64(II)Cl-2 is effective and well-tolerated in patients with UM, with higher SUVmax values in cancer patients compared to healthy subjects. Cu-64(II)Cl-2 PET/CT was found to be useful in patients affected by prostate, bladder, and penis cancer.