Diagnostic accuracy and validity of the O-RADS MRI score based on a simplified MRI protocol: a single tertiary center retrospective study

Background Adnexal masses (AM) are a common gynecological problem. It is important to use a reliable imaging method in the differentiation of benign and malignant AMs. Purpose To assess the accuracy and validity of the O-RADS magnetic resonance imaging (MRI) score for characterizing AM using a simplified MRI protocol. Material and Methods The study population comprised 332 women who underwent MRI due to the detection of indeterminate AM on ultrasonography between January 2018 and June 2020. An experienced radiologist calculated the O-RADS MRI score into five categories, using an MRI protocol with a simplified dynamic study. Sensitivity, specificity, positive and negative predictive values, and area under the curve (AUC) were calculated (cutoff for malignancy, score ≥ 4). The reference standard was histopathologic diagnosis or imaging findings during >24 months of follow-up. Results Of 237 AMs, 28 (11.9%) were malignant. The malignancy rates of AMs with scores of 1, 2, 3, 4, and 5 were 0% (0/12), 0% (0/111), 1.2% (1/77), 50% (10/20), and 100% (17/17), respectively. The O-RADS MRI score showed 96.3% sensitivity, 95.2% specificity, and 95.3% accuracy in malignancy prediction. The AUC for the differentiation of benign and malignant masses were 0.983. False positivity rate was high in cases with an O-RADS MRI score of 4 (50%). Conclusion The O-RADS MRI score, based on a simplified MRI protocol, has high accuracy and validity in distinguishing benign from malignant sonographically indeterminate AMs. Its use in clinical practice can classify the malignancy risks of masses and prevent unnecessary surgery in benign lesions.

Pediatric moyamoya MRI score: an imaging-based scale to predict outcomes in surgically treated pediatric patients with moyamoya

OBJECTIVE Moyamoya is a progressive arteriopathy that predisposes patients to stroke due to stenosis of the intracranial internal carotid arteries and their proximal branches. Despite the morbidity caused by this condition, the ability to accurately predict prognosis for individual patients remains challenging. The goal of this study was to develop a systematic scoring method based on parenchymal findings on preoperative brain MRI to predict long-term outcomes for surgically treated pediatric patients with moyamoya. METHODS A retrospective surgical cohort of pediatric patients (≤ 18 years of age at the time of the initial surgery) with moyamoya from a single center were studied. Radiological variables with existing correlations between outcomes in moyamoya or other vascular diseases were chosen to score preoperative MRI based on easily defined parenchymal findings that could be rapidly assessed and used to make a numeric score. Calculated scores were correlated with clinical outcome measures using the Pearson correlation coefficient and area under the receiver operating characteristic curve (AUROC). RESULTS A total of 35 children with moyamoya disease or moyamoya syndrome were included in the study, with a median follow-up time of 2.6 years from the time of surgery. The pediatric moyamoya MRI score (PMMS) consists of ischemic changes (0–2; 0 = none, 1 = focal, 2 = diffuse), encephalomalacia (0–2; 0 = none, 1 = focal, 2 = diffuse), and hemorrhage (0–1; 0 = not present, 1 = present). PMMSs were highly correlated with pediatric modified Rankin Scale scores at the last follow-up (r = 0.7, 95% CI 0.44–0.84; p < 0.001) as a six-point scale, and when dichotomized (AUROC = 0.85). CONCLUSIONS The PMMS was found to be a simple tool based on preoperative MRI data that could be quickly and easily calculated and correlated with disability. This scoring method may aid future development of predictive models of outcomes for children with moyamoya disease and moyamoya syndrome.

A prostate cancer risk calculator (PCRC-MRI): Use of clinical and magnetic resonance imaging data to predict biopsy outcome in North American men

Introduction: A functional tool to optimize patient selection for magnetic resonance imaging (MRI)-guided prostate biopsy (MRGB) is an unmet clinical need. We sought to develop a prostate cancer risk calculator (PCRC-MRI) that combines MRI and clinical characteristics to aid decision-making for MRGB in North American men. Methods: Two prospective registries containing 2354 consecutive men undergoing MRGB (September 2009 to April 2019) were analyzed. Patients were randomized into five groups, with one group randomly assigned to be the validation cohort against the other four groups as the discovery cohort. The primary outcome was detection of clinically significant prostate cancer (csPCa) defined as Gleason grade group greater than or equal to 2. Variables included age, ethnicity, digital rectal exam (DRE), prior biopsy, prostate-specific antigen (PSA), prostate volume, PSA density, and MRI score. Odds ratios were calculated from multivariate logistic regression comparing two models: one with clinical variables only (clinical) against a second combining clinical variables with MRI data (clinical+MRI). Results: csPCa was present in 942 (40%) of the 2354 men available for study. The positive and negative predictive values for csPCa in the clinical+MRI model were 57% and 89%, respectively. The area under the curve of the clinical+MRI model was superior to the clinical model in discovery (0.843 vs. 0.707, p<0.0001) and validation (0.888 vs. 0.757, p<0.0001) cohorts. Use of PCRC-MRI would have avoided approximately 16 unnecessary biopsies in every 100 men. Of all variables examined, Asian ethnicity was the most protective factor (odds ratio [OR] 0.46 [0.29–0.75]) while MRI score 5 indicated greatest risk (OR15.8 [10.5–23.9]). Conclusions: A risk calculator (PCRC-MRI), based on a large North American cohort, is shown to improve patient selection for MRGB, especially in preventing unnecessary biopsies. This tool is available at https://www.uclahealth.org/urology/prostate-cancer-risk-calculator and may help rationalize biopsy decision-making.

Thermal Index for early non-invasive assessment of brain injury in newborns treated with therapeutic hypothermia: preliminary report

Perinatal asphyxia (PA) is the 3rd most common cause of neonatal death and one of the most common causes of severe neurological impairments in children. Current tools and measurements mainly based on the analysis of clinical evaluation and laboratory and electrophysiological tests do not give consistent data allowing to predict the severity of hypoxic-ischemic encephalopathy (HIE) until a magnetic resonance imaging (MRI) score is performed. The aim of this work is to evaluate the usefulness of the new index, called Thermal Index (TI) in the assessment of the degree of brain damage in newborns in the course of therapeutic hypothermia (TH) due to PA. This was a prospective, observational, pilot study which did not require any changes in the applicable procedures. Analysis has been applied to six newborn babies treated with TH in Neonatal/Paediatric ICU in University Hospital in Opole in 2018 due to PA. They all met criteria for TH according to the current recommendations. Brain MRI was performed after the end of TH when the children were brought back to normal temperature, with the use of a 1.5 T scanner, using T1-, T2-weighted images, fluid-attenuated inversion recovery (FLAIR), inversion recovery (IR), susceptibility-weighted imaging (SWI), and diffusion-weighted imaging (DWI). The images were assessed using MRI score according to the scoring system proposed by Weeke et al. The Thermal Index assessing endogenous heat production was calculated according to the formula proposed in this paper. A high, statistically significant positive correlation was found between MRI scores and TI values (0.98; p = 0.0003) in the 1st hour of therapy. High correlation with MRI assessment, the non-invasiveness of measurements and the availability of results within the first few hours of treatment, allow authors to propose the Thermal Index as a tool for early evaluating of the brain injury in newborns treated with TH. Further research is required to confirm the usefulness of the proposed method.

P303 Local Application of Autologous Platelet-rich Plasma leads to Sustained Healing of Crohn’s Perianal Fistulae – One Year follow-up Results from a Single Center Pilot Study

Background Failure of wound repair and dysregulated inflammation in considered to play a key role in the persistence of Crohn’s perianal fistulae (pCD). Few preliminary reports suggest that autologous platelet-rich plasma (PRP) can enhance wound repair and may be effective in treating pCD. Therefore, the aim of our study was to determine the efficacy of autologous PRP in the treatment of pCD. Methods A prospective, uncontrolled, single center study in a referral IBD center was conducted between July 2018 and March 2021. Adult Crohn′s disease patients with pCD failing on antibiotics, immune suppression and/or biologics were eligible for the study. All patients had non-cutting setons for a minimal period of 6 weeks prior study intervention. Autologous PRP was separated by centrifugation 60 ml of peripheral blood in Harvest SmartPrep© System at the time of operation. After the seton removing, internal openings were closed by PDS 2/0 single suture and PRP was injected close to internal openings and fistula tracts. Patients were examined at outpatient clinic at week 1, month 1, 3, 6 and 12. Any suspected side-effects of the treatment were noted. Treatment effect was assessed by perianal Crohn Disease Activity Index (PCDAI assessed at baseline, month 1, 3, 6, 12) and van Assche MRI score (assessed at baseline and month 6 and 12). The primary end-point was complete healing at month 6 defined as closure of all external fistula openings and absence of abscess on MRI. The secondary end-point was sustained response at month 12. Results In total, 25 patients (pts) with pCD were included (mean age 36 years, range 21-61; 15 men). The majority of pts were using antiTNF biologics (9 adalimumab, 9 infliximab), 4 pts were treated by ustekinumab, one by vedolizumab, two patients were on immunomodulators monotherapy. By March 2021, 24 patients finished the 6 months and 21 patients the 12 months follow-up. The primary end-point of complete healing at month 6 was reached by 18 out of 24 pts (75%). All but one patients with complete healing had persistent complete healing at 12 months follow-up. Baseline PCDAI (median 5, range 2-15) decreased significantly as early as at month 1 (median 1, range 0-8; p&lt;0.001) and remained further stable over 12 months. Van Assche MRI score decreased significantly from median of 9 (range 3-18) at baseline to 5 (range 0-18) and 5.5 (range 0-18) at month 6 (p=0.001) and 12 (p=0.03); respectively. Conclusion Local application of autologous platelet-rich plasma leads to rapid healing of difficult-to-treat Crohn’s perianal fistulae in 75% of patients and this effect is sustained up to minimal period of one year.

P184 Secukinumab provides sustained improvements in clinical and imaging outcomes in patients with psoriatic arthritis and axial manifestations: results from the MAXIMISE trial

Background/Aims MAXIMISE, the first randomised controlled trial evaluating efficacy of a biologic for psoriatic arthritis (PsA) axial manifestations, showed that secukinumab 300 and 150 mg provided rapid and significant improvement in ASAS20 responses through Week 12. We report the effect of secukinumab on clinical and imaging outcomes through 52 weeks. Methods This Phase 3, double-blind, multicentre trial included 498 patients (≥18 years) with PsA who fulfilled CASPAR criteria presenting with spinal pain VAS ≥40/100, BASDAI ≥4 and inadequate response to ≥ 2 non-steroidal anti-inflammatory drugs. Patients were randomised to secukinumab 300 mg (N = 167), 150 mg (N = 165) or placebo (N = 166) weekly for 4 weeks and every 4 weeks thereafter. At Week 12, placebo patients were re-randomised to secukinumab 300/150 mg. The primary endpoint was ASAS20 with secukinumab 300 mg at Week 12. Exploratory assessments at Week 52 included ASAS20/40, BASDAI50, spinal pain (VAS) and improvement in Berlin magnetic resonance imaging (MRI) score for spine and sacroiliac joints. Results The primary endpoint was met. ASAS20/40 responses at Week 12 were 62.9%/43.6% (secukinumab 300 mg) and 66.3%/39.5% (secukinumab 150 mg) versus 31.2%/12.2% (placebo), respectively (P &lt; 0.0001). ASAS20/40 responses improved further with secukinumab 300/150 mg from baseline through 52 weeks. 74.1%/74.7% and 63.0%/50.6% of placebo patients, re-randomised at Week 12 to secukinumab 300/150 mg, achieved ASAS20/40 at Week 52. At baseline, 59.5% (secukinumab 300 mg), 54.2% (secukinumab 150 mg) and 64.2% (placebo) of patients had positive MRI scores for the sacroiliac joints and/or the spine. Reductions in Berlin MRI scores for the entire spine and sacroiliac joints were sustained with secukinumab 300/150 mg from baseline through 52 weeks (Table 1). 64.6%, 69.1% and 33.6% of patients with inflammatory back pain at baseline, confirmed by ASAS, Calin et al. and Berlin criteria in the secukinumab 300 mg, 150 mg and placebo groups, respectively, achieved ASAS20 at Week 12. P184 Table 1:Endpoints at Week 52CriteriaSecukinumab 300 mg SC (N = 164)Secukinumab 150 mg SC (N = 157)Placebo to secukinumab 300 mg SC (N = 81)Placebo to secukinumab 150 mg SC (N = 80)Clinical endpointsASAS20, % responders (n/M)a75.5 (123/163)77.3 (119/154)74.1 (60/81)74.7 (59/79)ASAS40, % responders (n/M)a62.6 (102/163)60.4 (93/154)63.0 (51/81)50.6 (40/79)BASDAI50, % responders (n/M)b68.3 (95/139)58.5 (83/142)55.6 (40/72)54.1 (40/74)Spinal pain VAS, mean change from BL (SD), nb-42.4 (27.0), 140-43.8 (26.2), 142-43.1 (25.0), 72-36.4 (25.2), 74Imaging endpointBerlin MRI score for entire spine, mean change from BL (SD), nb-0.6 (2.3), 121-0.3 (1.3), 124-0.8 (2.7), 63-0.4 (1.3), 60Berlin MRI score for SIJ, mean change from BL (SD), nb-0.7 (2.2), 122-0.5 (1.7), 122-0.9 (2.4), 63-1.0 (2.7), 59N=total number of patients in the group; n=number of patients with response; M=number of evaluable patients. aIntermediate missing data as well as any data missing in the case of study discontinuation is imputed using LOCF; bObserved data. Patients with initial placebo treatment were re-randomised to secukinumab 300 or 150 mg at Week 12. ASAS, Assessment of SpondyloArthritis International Society; BASDAI, Bath Ankylosing Spondylitis Disease Activity Index; BL, baseline; LOCF, last observation carried forward; MRI, magnetic resonance imaging; SC, subcutaneous; SD, standard deviation; SIJ, sacroiliac joints; VAS, visual analogue scale. Conclusion Secukinumab improved signs and symptoms of axial disease (ASAS20/40) through 52 weeks with reduced inflammatory MRI lesions in the spine and sacroiliac joints in PsA patients with axial manifestations. Efficacy at Week 52 was comparable in patients who switched at Week 12 from placebo to secukinumab 300/150 mg. Disclosure X. Baraliakos: Consultancies; AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB, Werfen. Member of speakers’ bureau; AbbVie, BMS, Celgene, Chugai, Merck, Novartis, Pfizer, UCB. Grants/research support; AbbVie, Novartis. L. Gossec: Consultancies; AbbVie, Amgen, Biogen, Celgene, Janssen, Lilly, Novartis, Pfizer, Sandoz, Sanofi-Aventis, UCB. Grants/research support; Lilly, Mylan, Pfizer, Sandoz. E. Pournara: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis stock. S. Jeka: Grants/research support; AbbVie, Pfizer, Roche, Novartis, MSD, Sandoz, Lilly, Egis, UCB, Celgene. R. Blanco: Consultancies; AbbVie, Lilly, Pfizer, Roche, Bristol-Myers, Janssen, UCB Pharma, MSD. Grants/research support; AbbVie, MSD, Roche. S. D'Angelo: Consultancies; AbbVie, Biogen, BMS, Celgene, Lilly, MSD, Novartis, UCB. Member of speakers’ bureau; AbbVie, BMS, Celgene, Lilly, Novartis, Pfizer, Sanofi. G. Schett: Honoraria; AbbVie, BMS, Celgene, Janssen, Lilly, Novartis, Roche, UCB. B. Schulz: Corporate appointments; Employee of Novartis. M. Rissler: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis stock. D. Whyms: Corporate appointments; Employee of Novartis. C. Perella: Corporate appointments; Employee of Novartis. Shareholder/stock ownership; Novartis stock. L.C. Coates: Consultancies; : AbbVie, Amgen, Biogen, Celgene, Pfizer, UCB, Boehringer Ingelheim, Novartis, Lilly, Janssen, Sun Pharma, Prothena, Gilead. Grants/research support; AbbVie, Janssen, Lilly, Novartis, Pfizer, Amgen.