Serum lactate dehydrogenase concentration after transcatheter renal artery embolization correlates with reduction in renal angiomyolipoma volume.

BACKGROUND: The extent of renal angiomyolipoma (AML) volume reduction after renal transcatheter arterial embolization (TAE) varies between patients, with no predictive measure available. PURPOSE: To determine whether the serum lactate dehydrogenase (LDH) concentration shortly after TAE correlates with the extent of tumor shrinkage. MATERIAL AND METHODS: In a cohort of 36 patients undergoing prophylactic renal TAE for unruptured renal AML, we retrospectively acquired data from patient medical records, including serum LDH before and within 7 days after TAE and the tumor volume before and 12-36 months after TAE. The relationship between the serum level of LDH and reduction in tumor volume was evaluated using Spearman correlation analysis. RESULTS: The median LDH concentration was significantly higher after TAE than before (909.0 U/L vs. 186.5 U/L). This early post-TAE serum LDH level and LDH index (post-TAE LDH / pre-TAE LDH) correlated significantly and positively with the absolute decrease in tumor volume (both P < 0.0001). We observed no significant correlation between the relative tumor volume reduction and serum LDH level or LDH index. CONCLUSION: Serum LDH elevation occurs shortly after TAE and correlates with the extent of absolute decrease in AML volume at 12-36 months after TAE. Further large-scale studies are warranted to confirm the predictive role of post-TAE serum LDH level and LDH index in tumor shrinkage in patients with unruptured renal AML.

Validation of algorithms to identify colorectal cancer patients from administrative claims data of a Japanese hospital.

BACKGROUND: Administrative claims data are a valuable source for clinical studies; however, the use of validated algorithms to identify patients is essential to minimize bias. We evaluated the validity of diagnostic coding algorithms for identifying patients with colorectal cancer from a hospital's administrative claims data. METHODS: This validation study used administrative claims data from a Japanese university hospital between April 2017 and March 2019. We developed diagnostic coding algorithms, basically based on the International Classification of Disease (ICD) 10th codes of C18-20 and Japanese disease codes, to identify patients with colorectal cancer. For random samples of patients identified using our algorithms, case ascertainment was performed using chart review as the gold standard. The positive predictive value (PPV) was calculated to evaluate the accuracy of the algorithms. RESULTS: Of 249 random samples of patients identified as having colorectal cancer by our coding algorithms, 215 were confirmed cases, yielding a PPV of 86.3% (95% confidence interval [CI], 81.5-90.1%). When the diagnostic codes were restricted to site-specific (right colon, left colon, transverse colon, or rectum) cancer codes, 94 of the 100 random samples were true cases of colorectal cancer. Consequently, the PPV increased to 94.0% (95% CI, 87.2-97.4%). CONCLUSION: Our diagnostic coding algorithms based on ICD-10 codes and Japanese disease codes were highly accurate in detecting patients with colorectal cancer from this hospital's claims data. The exclusive use of site-specific cancer codes further improved the PPV from 86.3 to 94.0%, suggesting their desirability in identifying these patients more precisely.

Clinical Practice Guidelines for tuberous sclerosis complex-associated renal angiomyolipoma by the Japanese Urological Association: Summary of the update.

New clinical issues have been raised through an interval of 7 years from the previous version (2016). In this study, we update the "Clinical Practice Guidelines for tuberous sclerosis complex-associated renal angiomyolipoma" as a 2023 version under guidance by the Japanese Urological Association. The present guidelines were cooperatively prepared by the Japanese Urological Association and Japanese Society of Tuberous Sclerosis Complex; committee members belonging to one of the two societies or specializing in the treatment of this disease were selected to prepare the guidelines in accordance with the "Guidance for preparing treatment guidelines" published by Minds (2020 version). The "Introduction" consisted of four sections, "Background Questions (BQ)" consisted of four sections, "Clinical Questions (CQ)" consisted of three sections, and "Future Questions (FQ)" consisted of three sections (total: 14 sections). Concerning CQ, an agreement was confirmed through voting by the committee members based on the direction and strength of recommendation, accuracy of evidence, and recommendation comments. The present guidelines were updated based on the current evidence. We hope that the guidelines will provide guiding principles for the treatment of tuberous sclerosis complex-associated renal angiomyolipoma to many urologists, becoming a foundation for subsequent updating.

Comorbidities and co-medications among 28 089 people living with HIV: A nationwide cohort study from 2009 to 2019 in Japan.

OBJECTIVES: Comorbidities are associated with a high burden of disease in people living with HIV (PLWH). The objective was to investigate the prevalence of chronic comorbidities and use of co-medications in PLWH in Japan. METHODS: This study retrospectively analysed clinical information from PLWH receiving antiretroviral therapy (ART) between April 2009 and March 2019. Demographic characteristics, numbers and types of chronic comorbidities, and numbers and types of non-ART co-medications, were described by age groups. The source of data was the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB). RESULTS: Overall, 28 089 PLWH (male 91.9%) who used ART were identified. Out of 28 089 PLWH, 81.5% had at least one chronic comorbidity. The numbers of AIDS-defining cancers and non-AIDS-defining cancers in this Japanese cohort were 2432 (8.7%) and 2485 (8.8%), respectively. The cumulative burden of comorbidities including non-AIDS-defining cancer increased with age. Changes in trend between 2009 and 2019 were observed, including a higher proportion of PLWH diagnosed at ≥ 70 years old [2019 (4.7%) vs. 2009 (2.4%)] and a decreasing percentage of patients with AIDS-defining cancers (down from 6.3% to 4.8% between 2009 and 2019). The most common co-medications during the most recent 3-month period were lipid-regulating/anti-atheroma preparations (11.3%), antacids, antiflatulents and anti-ulcerants (9.6%), and agents acting on the renin-angiotensin system (8.1%). The three most common therapeutic categories of co-medications during the study period were antacids, antiflatulents and anti-ulcerants (35.0%), systemic antihistamines (33.7%) and psycholeptics (27.1%). More than 30% of PLWH aged > 40 years used at least one co-medication in a 3-month period, while more than half of PLWH aged > 30 years had at least one co-medication prescribed concomitantly for a total of ≥ 90 days during the study period, and the numbers of co-medications used were greater in the older age groups. CONCLUSIONS: The burden of chronic comorbidities and co-medication were found to be greater in older, as compared to younger patients, among 28 089 PLWH in a nationwide study in Japan. This finding suggests the need to identify elderly PLWH and to appropriately manage their HIV and comorbidities.

Comparison of 1.5 T and 3 T non-contrast-enhanced MR angiography for visualization of uterine and ovarian arteries before uterine artery embolization.

OBJECTIVES: This study aimed to compare the performance of non-contrast-enhanced magnetic resonance angiography (NCE-MRA) at 1.5 T and 3 T for the visualization of uterine and ovarian arteries (OAs) before uterine artery embolization (UAE). METHODS: Preprocedural pelvic NCE-MRA images of 85 symptomatic patients undergoing UAE for the treatment of uterine leiomyomas were reviewed by two specialists in pelvic MRI. Left and right uterine arteries (UAs) were judged separately and scored on a 5-point scale. Score 5 was the highest, in which the UA could be visualized inside the musculature, forming a peritumoral plexus. Score 1 was the lowest, where visualization was limited to the descending segment. The detection of enlarged OAs was also compared. The Mann-Whitney U and Fisher exact tests were used for statistical analysis. p < 0.05 was considered to be statistically significant. RESULTS: Of the 170 UAs, 110 were classified at 1.5 T and 60 were classified at 3 T. Median (interquartile range [IQR]) score was 3 (IQR: 2-4) for visualization at 1.5 T vs 5 (IQR: 4-5) for 3 T. The scores for UA visualization were significantly higher at 3 T (p < 0.05). For enlarged OAs, NCE-MRA at 1.5 T and 3 T visualized 7 and 5 enlarged OAs, respectively; there was no significant difference between the two field strengths (p = 0.36). CONCLUSIONS: NCE-MRA performed at 3 T can visualize UAs over a greater range than at 1.5 T. No difference was found regarding the detection of enlarged OAs. KEY POINTS: • Preprocedural MRA can provide interventional radiologists with valuable information, including the origin and course of the uterine arteries and the existence of collateral feeders to the tumor. • This study demonstrates the superiority of non-contrast-enhanced MRA performed at 3 T over that performed at 1.5 T in the visualization of the uterine arteries in patients undergoing uterine artery embolization for the treatment of uterine leiomyomas. • Non-contrast-enhanced MRA is a useful imaging modality for patients with symptomatic leiomyoma undergoing uterine artery embolization in whom contrast administration is unfeasible. If available, it is preferable to perform the examination with a 3 T MR unit rather than a 1.5 T MR unit.

Delayed diagnosis of human immunodeficiency virus infection in people diagnosed with syphilis: A nationwide cohort study from 2011 to 2018 in Japan.

Early treatment of HIV infection depends on timely diagnosis, but many persons living with HIV/AIDS (PLWHA) are unaware of their infection. Though many patients seeking medical attention for sexually transmitted diseases have HIV, many patients' HIV co-infection is undiagnosed in Japan. This is the first report to analyze the timing of syphilis infection in PLWHA of all ages through the use of the National Database of Health Insurance Claims and Specific Health Checkups of Japan (NDB), containing clinical data of the largest group of HIV-positive patients available in Japan. Overall, 1521 PLWHA (male 93.2%) newly diagnosed and started on antiretroviral therapy were identified in 2016, and 646 (42.5%) patients had a diagnosis of syphilis between 2011 and 2018. Although 100 patients were diagnosed with syphilis before their HIV diagnosis, only 17 (17.0%) had been tested for HIV. Over 50 patients per year became infected with syphilis even after their HIV diagnosis (2017, n = 65 (4.3%); 2018, n = 58 (3.8%)). Although early diagnosis of HIV infection is important, most syphilis patients in Japan had not been properly tested for HIV infection. Since a certain number of HIV patients developed syphilis after HIV diagnosis, education for newly diagnosed HIV patients is important.

Syphilis in people living with HIV does not account for the syphilis resurgence in Japan.

OBJECTIVES: This study aimed to determine whether the current syphilis resurgence in Japan is attributable to incident syphilis in people living with HIV (PLWH). METHODS: This observational, retrospective, population-based study used data from the Japanese National Database. Data were extracted for PLWH who received antiretroviral treatment between January 2009 and December 2018. Using these data, along with the annual number of PLWH and syphilis diagnoses in the total population of Japan acquired from the National Institute of Infectious Diseases, the fraction of PLWH with syphilis compared to the total number of syphilis patients reported each year was calculated. RESULTS: There was a dramatic increase in syphilis cases during the study period. However, the incidence of syphilis in PLWH was stable during 2010-2018; the fraction of PLWH with newly diagnosed syphilis remaining at approximately 2% of the total PLWH cases in Japan each year. The proportion of newly diagnosed syphilis cases in PLWH decreased during the study period and accounted for <10% of the total syphilis cases in Japan since 2016 (14.9% in 2015 to 9.5% in 2016 and 5.9% in 2018). An increasing trend in the number of newly diagnosed syphilis cases in PLWH aged >50 years was observed (7.4% in 2010 to 10.4% in 2014 and 14.9% in 2018). CONCLUSIONS: The recent dramatic increase in syphilis cases in Japan was not seen in PLWH. Thus, the resurgence of syphilis in Japan cannot be attributed to its transmission in the PLWH population.

Levator ani asymmetry and deviation in high-type anorectal malformation evaluated by magnetic resonance imaging.

INTRODUCTION: The levator ani (LA) complex in high-type imperforate anus (H-IA), low-type imperforate anus (L-IA), and Hirschsprung's disease (HD) patients as controls were documented using magnetic resonance imaging (MRI) and compared for symmetry. MATERIALS AND METHODS: Mean left:right LA thickness ratio (LA ratio), and deviation of the LA from the pubococcygeal line (PCL; LA angle) were calculated from thin-slice MRI images (axial 2 mm, coronal 2 mm, and sagittal 3 mm) of the puborectalis and pubococcygeus taken parallel to the PCL under sedation in H-IA (n=14), L-IA (n=16), and HD (n=9). RESULTS: MRI scans were performed between January 2018 and June 2021. LA were significantly thinner in H-IA (1.78±0.46 mm) compared with L-IA (2.97±0.55 mm) and controls (2.87±0.32 mm), p<0.0001. LA ratio was significantly lower in H-IA (0.71±0.15) compared with L-IA (0.93±0.04), and controls (0.91±0.06), p<0.0001. Mean LA-angle was significantly different in H-IA, 10.8° (range 6°-19°), versus L-IA and controls, both zero degrees (range 0°-5°), p<0.0001, respectively. CONCLUSIONS: LA was confirmed to be significantly asymmetric in H-IA. Because outcome of surgical repair involving a midline incision, such as posterior sagittal anorectoplasty could be impaired, pediatric surgeons are advised to plan surgical intervention for H-IA carefully and appropriately.

Pneumococcal vaccination reduces in-hospital mortality, length of stay and medical expenditure in hospitalized elderly patients.

Pneumococcal vaccination has been shown to reduce occurrence of invasive pneumococcal diseases in elderly patients. In this study, we investigated the real-world efficacy of pneumococcal vaccination implemented in elderly individuals in Japan. We reviewed the in-patient database of Juntendo University Hospital and selected elderly patients (≥65 years-old) who had received in-patient care in the general medicine department during 2014-2018. A total of 1355 patients were retrospectively enrolled and comprised of 1045 unvaccinated and 315 vaccinated elderly individuals. Prior vaccination was found associated with all-cause shorter hospital stays (adjusted RR = 0.66, 95% CI = 0.57 to 0.76) and less medical expenditure (adjusted RR = 0.76, 95% CI = 0.66 to 0.87) compared with no vaccination, as well as protection for all-cause in-hospital mortality (adjusted OR = 0.42, 95% CI = 0.22 to 0.83). The association of shorter hospital stays and less medical expenditure with vaccination was also observed in the context of pneumonia, although no altered risk in mortality was observed. In conclusion, this study is one of the first reporting real-world data after the initiation of pneumococcal vaccination program in 2014 in Japan. The national PPV23 vaccination program contributed to the reduction of all-cause in-patient days, mortality, and medical expenses in the elderly aged ≥65 years. Further data is warranted to evaluate the contribution from influenza vaccination and protein-conjugate based pneumococcal vaccine.

Perforation in pediatric non-complicated appendicitis treated by antibiotics: the real incidence.

PURPOSE: The incidence of perforation during antibiotic therapy (AT) of children triaged as non-complicated acute appendicitis (NC-Ap) was investigated. METHODS: Abdominal ultrasonography (US) and/or computed tomography (CT) scans from cases of perforation identified at appendectomy for failed AT were reassessed blindly by a panel of board-certified specialists for any evidence of pre-AT morbidity suggestive of perforation. RESULTS: Of 521 cases triaged as NC-Ap, symptoms resolved with AT in 452 cases (86.8%). All 69/521 (13.2%) cases with persistent symptoms had urgent appendectomy, and 12/521 (2.3%) were found to have perforated. Blind reassessment of US and/or CT scans from these cases identified seven with evidence of perforation when they were triaged as NC-Ap. Thus, the actual incidence of perforation during AT for NC-Ap was actually 12-7 = 5/521 (0.95%). CONCLUSIONS: Perforation is generally believed to be a complication of AT, but inappropriate triaging of cases for AT can bias results by artificially inflating the number of perforations, in this study, by more than double. We are the first to assess the unbiased incidence of perforation during AT for NC-Ap, by reassessing pre-AT US and/or CT scans. The incidence of perforation during AT is actually negligible.

Can we predict the existence of extrarenal feeders to renal angiomyolipomas?

OBJECTIVES: To identify factors predicting the presence of extrarenal feeders to renal angiomyolipomas (AMLs) METHODS: This is a retrospective study of 44 patients with 58 renal AMLs embolized in our department. Arteriography obtained during embolization and CT angiography obtained before and after embolization were reviewed to characterize AMLs with and without extrarenal feeders. Tumor characteristics were compared between the two groups. Simple logistic regression and ROC curve analysis were performed. P < 0.05 was considered to be statistically significant. RESULTS: Of the 58 AMLs reviewed, 29% had extrarenal arteries and 71% did not. AMLs with extrarenal feeders were significantly larger than those without, in terms of volume (median, 368 mL versus 109 mL, p < 0.0002) and the largest diameter (mean, 12.0 cm versus 7.7 cm, p < 0.0001). Patient age, presence of tuberous sclerosis complex or sporadic lymphangioleiomyomatosis, and tumor location did not differ between the groups. The largest diameter and volume had similar predictive values for the presence of extrarenal feeders (AUC, 0.83 versus 0.82, p = 0.673). Extrarenal feeders were present in 0%, 21%, and 79% of the AMLs ≤ 6.5 cm, AMLs 6.6-10.5 cm, and AMLs > 10.5 cm, respectively. CONCLUSIONS: AML size correlates with the presence of extrarenal feeders, with the largest diameter and volume being significant predictors. AMLs > 10.5 cm had a high chance of extrarenal feeders, making it mandatory to search for feeders to them in order to avoid incomplete embolization; AMLs ≤ 6.5 cm did not have extrarenal feeders, making a search for them unnecessary in these cases. KEY POINTS: • The presence of extrarenal feeders to renal angiomyolipoma is associated with tumor size, but not with patient age, concomitant disease, or tumor location. • The largest diameter and volume predict the presence of extrarenal feeders to AML, with similar predictive values. • AMLs > 10.5 cm have a high chance (79%) of extrarenal feeders, making it mandatory to search for feeders to them in order to avoid incomplete embolization; AMLs ≤ 6.5 cm do not have extrarenal feeders, making a search for them unnecessary in these cases.

Significance of hypovascular lesions on dynamic computed tomography and/or gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid-enhanced magnetic resonance imaging in patients with hepatocellular carcinoma.

BACKGROUND AND AIM: The natural course and clinical implications of hypovascular lesions on dynamic computed tomography and/or gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid-enhanced magnetic resonance imaging were investigated. METHODS: We followed the patients with hepatocellular carcinoma (HCC) who underwent hepatectomy between April 2009 and August 2012 to determine whether new classical HCCs developed from these unresected borderline lesions or emerged in different areas. RESULTS: One hundred and eleven patients with HCC were identified to have undergone examinations using both imaging methods before hepatic resection. A total of 54 hypovascular lesions were detected. Gadolinium ethoxybenzyl-enhanced magnetic resonance imaging detected 51 lesions, while dynamic computed tomography identified 21 lesions. Eleven lesions were resected at the time of the hepatectomy together with the main HCCs. Classical HCCs had developed from 52.5% of the 43 unresected lesions at 3 years after hepatic resection. Subsequently, we conducted a patient-by-patient analysis to compare the development of classical HCC from these hypovascular lesions and the emergence of de novo classical HCC in other areas. The 3-year occurrence rate was 62.2% for the former group and 55.0% for the latter group (P = 0.83). Thus, although 52.2% of these hypovascular lesions had developed into classical HCCs at 3 years after the initial hepatectomy, de novo HCCs also occurred at other sites. Furthermore, new hypovascular lesions emerged after hepatectomy in 18-29% of patients irrespective of the presence or absence of hypovascular lesions at hepatectomy. CONCLUSIONS: It remains uncertain whether these hypovascular lesions should be resected together with the main tumors at the time of hepatectomy.

[A Case of Good Quality of Life(QOL)and Favorable Response to Transarterial Chemoembolization(TACE)against Synchronous Multiple Liver Metastases].

We report a case of good quality of life(QOL)and favorable response to transarterial chemoembolization(TACE)against synchronous multiple liver metastases. An 85-year-old man was admitted to our hospital because of melena. Colonoscopy showed multiple type 2 tumors in the sigmoid colon and upper rectum. CT and EOB-MRI examinations revealed that there were multiple liver metastases. Because of his age and surgical stress, he underwent a laparoscopic Hartmann's procedure. After the resection of the primary tumor, he received tegafur/uracil for his liver metastases. However, he discontinued receiving the drugs 2 weeks later because of the development of adverse events. Instead of systemic chemotherapy, he chose to undergo TACE. He underwent TACE with irinotecan and HepaSphereTM(BioSphere Medical)8 times for his multiple liver metastases. Consequently, all multiple liver metastases disappeared. Therefore, TACE may be useful for patients who are not suitable for systemic chemotherapy.

Superselective Transcatheter Arterial Embolization for Large Unruptured Renal Angiomyolipoma in Lymphangioleiomyomatosis.

PURPOSE: To retrospectively evaluate therapeutic performance and complications of superselective transcatheter arterial embolization (TAE) for unruptured renal angiomyolipoma (AML) in patients with lymphangioleiomyomatosis (LAM) and to investigate the correlation between percentage reduction in tumor volume and intratumoral fat content. MATERIALS AND METHODS: Superselective TAE was performed in 14 consecutive patients with 15 large unruptured renal AMLs associated with LAM (mean age, 38 y; range, 21-57 y). Patients had renal AML with aneurysms ≥ 5 mm in diameter, tumor-related abdominal symptoms, or both. In all cases, embolization of 1 tumor was achieved in a single session by using multiporous gelatin sponge particles (GSPs) with additional metallic coils in all but 1 case. Tumor volume and fat content percentage were measured on CT or MR imaging before and after superselective TAE (median, 11 months; range, 6-14 months). RESULTS: Residual tumor staining declined by > 90% after all TAE sessions except 2, with embolization of all treated aneurysms. No nontarget embolization or severe complications were encountered. Mean percentage reduction in tumor volume after superselective TAE was 69% (range, 21%-95%). Percentage tumor volume reduction was negatively correlated with fat content before embolization (P < .01). CONCLUSIONS: Superselective TAE with multiporous GSPs and metallic coils for large unruptured renal AML in patients with LAM is useful for reducing tumor volume and treating intratumoral aneurysms without major pulmonary or renal complications. Extent of tumor reduction may be influenced by fat content before embolization.

Pulmonary lobectomy techniques in infants and children.

Thoracoscopic pulmonary lobectomy (TPL) techniques in infants and children are presented practically with concise descriptions and numerous illustrations. TPL is the treatment of choice for congenital pulmonary airway malformation and intralobar pulmonary sequestration, both now commonly diagnosed prenatally. Timing of surgery is somewhat controversial in asymptomatic cases with small isolated lesions. Incomplete fissures and history of chest infections are most problematic. Thorough understanding of anatomic relations preoperatively is vital for successful outcome and thin-slice computed tomography with 3D reconstruction of vessels is valuable. Judicious placement of trocars and switching instruments between trocars improves visualization and safety. Specific techniques for all commonly performed TPL are included.

Biochemical and Clinical Predictive Approach and Time Point Analysis of Hepatobiliary Phase Liver Enhancement on Gd-EOB-DTPA-enhanced MR Images: A Multicenter Study.

Purpose To identify biochemical factors associated with liver enhancement over time on gadolinium ethoxybenzyl diethylenetriamine pentaacetic acid (Gd-EOB-DTPA)-enhanced magnetic resonance (MR) images and predict the optimal time point of the hepatobiliary phase in various clinical settings. Materials and Methods This study was approved by the institutional review boards, and written informed consent was obtained from the 1903 patients enrolled. Simple and multiple logistic regression analyses were performed to investigate the biochemical factors associated with liver-to-spleen contrast (LSC) of at least 1.5 in the hepatobiliary phase. Changes in LSC and lesion-to-liver contrast (LLC) of lesions over time (at 5, 10, 15, and 20 minutes) were investigated with a linear mixed-effects model in patients and lesions. For LSC, the optimal cutoff value was determined with receiver operating characteristic analysis of the most significant variable. Differences in LSC and LLC were analyzed in various clinical settings. Results Ultimately, 1870 patients were evaluated, as 33 were excluded according to study criteria. Prothrombin (PT) activity, total bilirubin level (P = .020), and total cholesterol level (P = .005) were significantly associated with LSC of at least 1.5 at 20 minutes, and PT activity was identified as the most significant factor (odds ratio, 1.271; 95% confidence interval: 1.109, 1.455; P = .001). LSC of at least 1.5 at 20 minutes with PT activity of at least 86.9% and less than 86.9% occurred in 555 of 626 patients (88.6%) and 388 of 575 patients (67.5%), respectively. Satisfactory liver enhancement at 20 minutes was significantly more likely to be achieved by patients with hepatitis B virus than by those with hepatitis C virus (P < .001) and by patients with metastasis than by those with hepatocellular carcinoma (P < .001). No significant difference in LLC was observed in patients examined at 1.5 and 3.0 T (P = .133). Conclusion Hepatic enhancement is significantly associated with PT activity, total bilirubin level, and total cholesterol level. PT activity of at least 86.9% could be used to shorten examination times at Gd-EOB-DTPA-enhanced MR imaging. © RSNA, 2016 Online supplemental material is available for this article.

A multicenter, randomized, controlled, single-blind comparison phase III study to determine the efficacy and safety of gadobutrol 1.0 M versus gadopentetate dimeglumine following single injection in patients referred for contrast-enhanced MRI of the body regions or extremities.

PURPOSE: To demonstrate the noninferiority of gadobutrol-enhanced magnetic resonance imaging (MRI) compared with gadopentetate dimeglumine-enhanced MRI in Asian patients referred for contrast-enhanced imaging of the body or extremities. MATERIALS AND METHODS: A multicenter, parallel-group comparison study of Asian adults referred for contrast-enhanced MRI were randomized (1:1) to either gadobutrol or gadopentetate dimeglumine. Lesions were assessed for three primary visualization variables: degree of contrast enhancement, border delineation, and internal morphology. Secondary efficacy variables included number of lesions detected, match of MRI diagnosis with final clinical diagnosis, and sensitivity and specificity for malignant lesion detection. Safety was monitored for 24 ± 4 hours after contrast agent administration. RESULTS: A total of 363 patients received either gadobutrol (n = 168) or gadopentetate dimeglumine (n = 178). Mean total scores for three primary visualization variables were 9.39 and 9.34 for gadobutrol and gadopentetate dimeglumine, respectively. The proportion of patients with matched MRI and final diagnosis and sensitivity for malignant lesion detection was greater for unenhanced versus combined images (gadobutrol: 72.2% vs. 81.7%; gadopentetate dimeglumine: 76.2% vs. 82.2%, respectively). Both contrast agents were well tolerated. CONCLUSION: Gadobutrol (0.1 mmol/kg BW) was well tolerated and effective in Asian patients referred for contrast-enhanced MRI of the body or extremities.

Relationship between cognitive impairment and white-matter alteration in Parkinson's disease with dementia: tract-based spatial statistics and tract-specific analysis.

OBJECTIVES: We investigated the relationship between white-matter alteration and cognitive status in Parkinson's disease (PD) with and without dementia by using diffusion tensor imaging. METHODS: Twenty PD patients, 20 PDD (Parkinson's disease with dementia) patients and 20 age-matched healthy controls underwent diffusion tensor imaging. The mean diffusivity and fractional anisotropy (FA) map of each patient group were compared with those of the control group by using tract-based spatial statistics. Tractography images of the genu of the corpus callosum fibre tracts were generated, and mean diffusivity and FA were measured. RESULTS: FA values in many major tracts were significantly lower in PDD patients than in control subjects; in the prefrontal white matter and the genu of the corpus callosum they were significantly lower in PDD patients than in PD patients. There was a significant correlation between the Mini-Mental State Examination (MMSE) scores and the FA values of the prefrontal white matter and the genu of the corpus callosum in patients with PD. CONCLUSIONS: Our study shows a relationship between cognitive impairment and alteration of the prefrontal white matter and genu of the corpus callosum. These changes may be useful in assessing the onset of dementia in PD patients. KEY POINTS: • Dementia is a common and important non-motor sign of Parkinson's disease (PD). • The neuropathological basis of dementia in PD is not clear. • DTI shows abnormalities in the prefrontal white matter in PD with dementia. • Prefrontal white matter alteration may be useful biomarker of dementia in PD.