FIFor the German National Cohort MRI Study Investigators
For the German National Cohort MRI Study Investigators
+25
To identify and establish novel imaging-based biomarkers of risk, the German National Cohort MR imaging study is designed as a prospective cohort study that will enroll 30 000 participants and will apply a highly standardized study set with respect to technical equipment, quality management, and algorithms for the management of incidental findings. Purpose To detail the rationale, design, and future perspective of implementing whole-body magnetic resonance (MR) imaging in the German National Cohort, a large multicentric population-based study. Materials and Methods All institutional review boards approved the study, and informed consent is obtained before study enrollment. Participants are enrolled from a random sample of the general population at five dedicated imaging sites among 18 recruitment centers. MR imaging facilities are equipped with identical 3.0-T imager technology and use uniform MR protocols. Imager-specific hardware and software settings remained constant over the study period. On-site and centralized measures of image quality enable monitoring of completeness of the acquisitions and quality of each of the MR sequences. Certified radiologists read all MR imaging studies for presence of incidental findings according to predefined algorithms. Results Over a 4-year period, six participants per day are examined at each center, totaling a...
A panel of experts reached consensus on recommendations on when to assess oncologic outcomes per patient, per session, and per tumor; definitions of starting and ending times; definitions of surviv... There is currently no consensus regarding preferred clinical outcome measures following image-guided tumor ablation or clear definitions of oncologic end points. This consensus document proposes st...
14 February 2013 in Magnetic Resonance in Medicine
Objective In this pilot study, the effect of sildenafil on digital ulcer (DU) healing and related clinical symptoms was analysed. Methods A total of 19 patients with systemic sclerosis (SSc) were treated with maximally tolerated sildenafil doses up to 6 months. Primary outcome was the healing of DUs. Changes in other clinical symptoms were also evaluated. Results In all, 49 DUs were present at baseline; this decreased to 17 ulcers (p<0.001) at the end of sildenafil treatment. Furthermore, the visual analogue scale (VAS) score for Raynaud's phenomenon (RP), pain and activity improved (p=0.003, p=0.002 and p=0.05, respectively). A total of 9 patients developed 12 new DUs during sildenafil treatment. Conclusions This study indicates an effect of sildenafil on DU healing in patients with SSc and an improvement of RP and associated symptoms that should be validated in controlled studies.
To determine the effect of partial versus complete leiomyoma infarction on relief of leiomyoma-related symptoms and freedom from invasive reinterventions and to assess if patient age, location of the dominant leiomyoma, number of leiomyomas, or baseline uterine and dominant leiomyoma volume were associated with clinical failure. Study protocol was approved by the institutional review board, and informed consent was obtained. One hundred fifteen consecutive women (median age, 42 years; range, 34-61 years) with symptomatic uterine leiomyomas underwent contrast material-enhanced magnetic resonance (MR) imaging at baseline and 24-72 hours after uterine artery embolization (UAE) to determine the percentage of infarction of leiomyoma tissue (complete = 100%, almost complete = 90%-99%, and partial = 0%-89%). Clinical outcome and frequency of reinterventions were compared for up to 36 months. One hundred thirteen patients completed at least one clinical follow-up. Twenty-four months after UAE, 50% +/- 15.2 (standard error) of the patients with partial infarction and 80% +/- 13.4 (standard error) of patients with almost complete infarction had undergone no reintervention. No patient with complete infarction needed a second treatment (P < .001). The hazard ratios for reintervention between the complete infarction group and the almost complete and partial infarction groups were 15.88 (95% confidence interval [CI]: 1.22, 2225.54; P = .034) and 73.08 (95% CI: 8.33, 9636.35; P < .001), respectively. There were significant differences in hazard ratios between patients with partial and those with complete infarction for persistence or recurrence of menorrhagia (hazard ratio, 7.45; 95% CI: 2.08, 28.31; P = .002) and bulk-related symptoms (hazard ratio, 5.90; 95% CI: 1.66, 21.92; P = .007). There was no significant correlation between patient age, number of leiomyomas, location of the dominant leiomyoma, or baseline uterine and dominant leiomyoma volume and clinical failure. Women with leiomyoma infarction above 90% on contrast-enhanced MR images after UAE show significantly better symptom control and fewer reinterventions than do patients with a lower infarction rate.