ABSTRACT
To assess the safety profile of iso-osmolar contrast medium (CM) versus low osmolar CM in cancer patients with an estimated glomerular filtration rate (eGFR) >60 ml/min. In this multicenter, blind trial of patients seeking a chest-abdomen-pelvis contrast enhanced computed tomography (CT) with iodated CM, participants were centrally randomized to iodixanol or iopromide. Contrast induced nephropathy (CIN) at 24 and/or 72 hr were our primary outcomes. We further considered irreversible CIN, average eGFR percentage variation (%Δ), and adverse events (AEs). Overall, 607 patients were enrolled. Among them, 497 eligible patients were randomized to iodixanol (N: 247) or iopromide (N: 250). No differences emerged by descriptive characteristics. Seven and 3 CIN at 24 hr (p = 0.34) and 8 and 2 CIN at 72 hr (p = 0.11) occurred in the iopromide and iodixanol group, respectively. Within the subgroup of individual patients who developed CIN (N: 17), the event rate was higher in the iopromide arm (p = 0.045). No cases of permanent CIN or significant differences in terms of AEs or GFR %Δ were observed. Our results suggest a more favorable safety profile of iodixanol versus iopromide. Adequately sized trials with similar design are warranted to confirm our findings and clarify the underlying biological mechanisms.
Subject(s)
Contrast Media/adverse effects , Iohexol/analogs & derivatives , Kidney Diseases/chemically induced , Kidney/drug effects , Neoplasms/diagnostic imaging , Tomography, X-Ray Computed , Triiodobenzoic Acids/adverse effects , Adolescent , Adult , Aged , Contrast Media/administration & dosage , Female , Glomerular Filtration Rate/drug effects , Humans , Iohexol/administration & dosage , Iohexol/adverse effects , Italy , Kidney/physiopathology , Kidney Diseases/diagnosis , Kidney Diseases/physiopathology , Male , Middle Aged , Neoplasms/pathology , Patient Safety , Predictive Value of Tests , Risk Factors , Time Factors , Tomography, X-Ray Computed/adverse effects , Triiodobenzoic Acids/administration & dosage , Young AdultABSTRACT
PURPOSE: To assess the diagnostic performance of multiparametric MRI (mpMRI), in the detection of prostate cancer, including morphologic sequences (mMRI), diffusion-weighted imaging (DWI), and MR spectroscopy (MRS). Combined morphological and functional MRI scoring systems was used for urologicalradiological work-up of patients with a prostate-specific antigen (PSA) value ≤ 10 ng/mL. MATERIALS AND METHODS: The study included 136 of 200 consecutive patients with PSA values between 2.5 and 4 ng/mL and an abnormal digital rectal examination (DRE), or patients with PSA values between 4 and 10 ng/mL, independently from DRE. Each patient provided informed consent to undergo at serum free/total PSA ratio (f/t PSA) assay, mMRI, MRS, DWI, and transrectal ultrasonography (TRUS) biopsy. The MRI datasets were scored singularly; then mMRI and DWI, mMRI and MRS data were combined in a coupled score, and finally mMRI, DWI, and MRS data were combined in a single score (cMRI score). RESULTS: Scores were correlated to negative biopsies and significant/insignificant Gleason score biopsies. Receiver-operator-characteristic curve and McNemar tests were performed. Cancer was diagnosed in 18% of patients. The cMRI score showed: (i) the highest sensitivity (0.84) and negative predictive value (0.93); (ii) a significant correlation with Gleason score; and (iii) a statistically different median value between significant and insignificant Gleason score. CONCLUSION: The cMRI score could identify patients with a PSA≤10 ng/mL who will have a negative work-up, for its high negative predictive value, and patients at high risk for significant prostate cancer because of its correlation with the Gleason score
