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 (64Cu(II)Cl2) 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 64Cu(II)Cl2 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 64Cu(II)Cl2 uptake in UM and normal tissues, SUVs were calculated. The safety of 64Cu(II)Cl2 was assessed. RESULTS: Twenty-three patients were included. An administered activity of 174.7 MBq (4.72 mCi) for 64Cu(II)Cl2 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: 64Cu(II)Cl2 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 64Cu(II)Cl2 PET/CT is useful in patients affected by prostate, bladder, and penis cancer.

Prevalence and predictors of low bone mineral density and fragility fractures among HIV-infected patients at one Italian center after universal DXA screening: sensitivity and specificity of current guidelines on bone mineral density management.

Low bone mineral density (BMD) is frequent in HIV infection regardless of the use of antiretroviral therapy (ART). Uncertainties remain, however, as to when in HIV infection BMD screening should be performed. We designed a prospective study to estimate the efficacy of universal BMD screening by dual-energy X-ray absorptiometry (DXA). Since April 2009 through March 2011, HIV patients attending our Center were offered femoral/lumbar DXA to screen BMD. Low BMD for chronological age, that is significant osteopenia, was defined as a Z-score ≤ -2.0 at femur and lumbar spine. Nontraumatic bone fractures (NTBFs) were evaluated. The final sample included 163 patients. A Z-score ≤ -2.0 at any site was observed in 19.6% of cases: among these, 18.8% had no indication to DXA using current Italian HIV guidelines for BMD screening. A lower femoral Z-score was independently associated with lower BMI, AIDS diagnosis, HCV co-infection, antiretroviral treatment, and NTBFs; a lower lumbar Z-score with age, BMI, Nadir CD4 T-cell counts, and NTBFs. Prevalence of NTBFs was 27.0%, predictors being male gender, HCV co-infection, and lower femoral Z-scores. Our results suggest that measuring BMD by DXA in all HIV patients regardless of any further specification may help retrieving one-fifth of patients with early BMD disorders not identified using current criteria for selective screening of BMD.