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02:11 CET
CT 10 - Clinical Trials in Radiology 3
Breast Imaging Informatics Vascular Neuro Musculoskeletal
Friday, March 2, 10:30 - 12:00
Moderators: M. Dewey (Berlin/DE), R. L. Ehman (Rochester/US)

Breast cancer screening with tomosynthesis: distribution of cancer subtypes in the Malmö Breast Tomosynthesis Screening Trial
K. S. Johnson1, S. Zackrisson1, A. Rosso1, H. Sartor1, I. Andersson1, L. H. Saal2, K. Lang1; 1Malmö/SE 2Lund/SE

Purpose: Digital breast tomosynthesis (DBT) has the potential of becoming the new breast cancer screening modality. It is, however, not known if DBT screening will change the types of cancers detected. We analysed the tumour biology of invasive breast cancers detected in the Malmö Breast Tomosynthesis Screening Trial (MBTST), using the St. Gallen surrogate subtype classification, clinically used for prognostic and treatment guidance.
Ethics committee approval: The study was approved by the Regional Ethical Review Board at Lund University (Dnr 2009/770). Written informed consent was obtained.
Methods and Materials: The MBTST is a prospective, population-based one-arm screening trial comparing one-view DBT with two-view digital mammography (DM). 14 848 women were enrolled and in total 118 invasive cancers were detected. The cancers were classified according to St. Gallen; luminal A-like, luminal B-like HER2-/HER2+, HER2+ and triple negative. The subtypes were presented by mode of detection; DBT alone compared to all DM detected cancers.
Results: In total, 38 breast cancers were detected with DBT alone (37 with subtypes): 19 (50%) luminal A-like, 14 (37%) luminal B-like HER2-, 0 (0%) luminal B-like HER2+, 1 (3%) HER2+ and 3 (8%) triple negative. 80 cancers were detected with both DBT and DM (n=76) or DM alone (n=4): 37 (46%) luminal A-like, 34 (42%) luminal B-like HER2-, 1 (1%) luminal B-like HER2+, 3 (4%) HER2+ and 5 (6%) triple negative.
Limitations: The study was performed on an urban Swedish population using one particular brand of tomosynthesis equipment and might, therefore, not be generalizable to other populations and to the use of other tomosynthesis vendors.
Conclusion: Invasive cancers detected with DBT alone or DM in the MBTST were of similar subtypes according to the St. Gallen classification indicating that DBT screening may not alter the treatment predictive and prognostic panorama of screen-detected cancers.
Funding for this study: Swedish Research Council, Swedish Cancer Society, Skane county council´s research and development foundation, Medical Faculty at Lund University (ALF grant), Unilabs Sweden and Siemens Healthineers.

F. J. Gilbert; Cambridge/GB
Digital breast tomosynthesis vs digital mammography: recallrate by mammographic density, interim analyses
H. Aase1, Å. S. Holen2, B. Hanestad1, S. Hofvind2; 1Bergen/NO 2Oslo/NO

Purpose: To compare recall rates using synthetic mammography + digital breast tomosynthesis (SM+DBT) versus digital mammography (DM) in the Norwegian Breast Cancer Screening Program, stratified by mammographic density.
Ethics committee approval: The study is approved by the Regional committees for medical and health research ethics (2015/424) and registered in Clinical trials.org (NCT02835625).
Methods and Materials: As part of a randomised controlled screening trial performed in Bergen, 7037 women were screened with SM+DBT and 7052 with DM, January-December 2016. We obtained continuous measures of volumetric breast density (VBD) using an automated software (Volpara version 1.5.1). Recall rate for positive mammographic findings was calculated for women who underwent screening with the two techniques, stratified by quartiles of VBD; (1:< 3.5%; 2: 3.5-5.4%; 3: 5.4-8.8% and 4: >8.8%). Two-proportion z-tests was used to test for statistical significance between the groups (p<0.05).
Results: Recall rate was statistically significantly lower for SM+DBT (3.0% [208/7037]) compared to DM (3.6% [254/7052], p=0.03). The recall rate increased by mammographic density for SM+DBT, from 2.1% for VBD-1 to 4.5% for VBD-4. For DM, the recall rate remained the same for different quartiles of mammographic density. For DM, the highest recall rate (4.3%) was observed for VBD-3.
Limitations: The radiologists had limited experience with DBT when the trial started.
Conclusion: Women screened with SM+DBT had a lower recall rate compared to those screened with DM. The higher recall rate among women with dense breast and screened with SM+DBT need to be followed closely according to cancer detection and rate of false positive screening results.
Funding for this study: The project is funded by the Norwegian Research Council.

E. M. Fallenberg; Berlin/DE
Reduction in infarct volume on CT and functional outcome after endovascular treatment for acute ischaemic stroke: a causal mediation analysis
K. Compagne1, M. Boers2, H. Marquering2, C. B. Majoie2, W. Van Zwam3, D. W. Dippel1, A. van Es1, A. Van der Lugt1, H. Lingsma1; 1Rotterdam/NL 2Amsterdam/NL 3Maastricht/NL

Purpose: A potential explanation for the favourable effect of endovascular treatment (EVT) on functional outcome after acute ischaemic stroke is a reduction in ischaemic lesion volume (ILV). ILV is strongly related to the functional outcome. The aim of the present study was to assess to which extent ILV also explains the effect of EVT on functional outcome.
Ethics committee approval: The study protocol of the MR CLEAN trial was approved by a central medical ethics committee and the research board of each participating center. All patients or their legal representatives provided written informed consent before randomisation.
Methods and Materials: The data of all 500 patients included in the randomised controlled MR CLEAN trial on the effectiveness of EVT were evaluated. ILV was assessed on non-contrast CT scan 5 days after stroke. The functional outcome was the score on the modified Rankin Scale at three months. We tested the pathway from EVT via ILV to functional outcome with a mediation model, using ordinal regression, with adjustment for relevant baseline covariates.
Results: In total, 452 patients were analysed. EVT patients had better outcome (acOR 2.01 (95%CI 1.43-2.82). EVT patients had smaller median ILV (55 mL) than non-EVT patients (80 mL) (absolute difference 25 mL; 95%CI 17.26-44.92). ILV was inversely associated with better outcome (common odds ratio (cOR) per 10 mL 0.58; 95%CI 0.51-0.66). After adjustment for ILV, the effect of EVT on the outcome decreased, but remained substantial (acOR 1.80; 95%CI 1.28-2.55). Reduction of ILV explained 16% of the beneficial effect of EVT on outcome.
Limitations: A limitation of our study is the exclusion of deceased patients in the first week after onset and therefore missing FIV measurements at 5-7 day follow-up which is tried to overcome by imputation.
Conclusion: The reduction of ILV by EVT explains only part of the effect on functional outcome. Before ILV is used as a primary outcome in efficacy trials, improvement of this potentially valuable outcome measure is needed.
Funding for this study: The MR CLEAN trial was partly funded by the Dutch Heart Foundation and by unrestricted grants from AngioCare BV, Medtronic/Covidien/EV3®, MEDAC Gmbh/LAMEPRO, Penumbra Inc., Stryker®, and Top Medical/Concentric. The MR CLEAN is registered under number NTR1804 in the Dutch trial register and under ISRCTN10888758 in the ISRCTN register. Erasmus Medical Center Rotterdam received funds from Stryker® for consultations by AvdL, AvE and DD and from Bracco Imaging® for consultations by DD. Academic Medical Center Amsterdam received funds from Stryker® for consultations by CM, YR and OB. AB and HM own stock in Nico-lab B.V. Maastricht University Medical Center received funds from Stryker® and Cerenovus® for consultations by WZ. AY reports research grants form Penumbra Inc. and Neuravi Inc., and consultant fees from Cerenovus/J&J. No other personal disclosures are reported.

I. Szikora; Budapest/HU
Radiologic follow-up of the NU-AGE trial: body composition changes detected by dual-energy x-ray absorptiometry show a correlation with laboratory markers of inflammation
D. Mercatelli1, A. Santoro1, G. Guidarelli1, C. Fabbri1, R. Ostan1, A. Berendsen2, B. Pietruszka3, A. jennings4, N. Meunier5, M. Aparisi Gomez6, E. Caumon1, S. Fairweather-Tait4, A. Bialecka3, C. de Groot7, G. Guglielmi8, G. Battista1, C. franceschi1, A. Bazzocchi1; 1Bologna/IT 2Wageningen/NL 3Warsaw/PL 4Norwich/GB 5Clermont-Ferrand/FR 6Auckland/NZ 7Wageningen/IT 8Andria/IT

Purpose: To investigate changes in body composition(BC) parameters detected by dual-energy X-ray absorptiometry(DXA) in an elderly population following a one-year dietary intervention to build a predictive model of risk integrating omics data. The specific aim of this work was to investigate the degree of correlation between changes in BC and plasma levels of inflammatory markers.
Ethics committee approval: The 5 centres involved in the study obtained protocol approval by local Ethics committees. Informed consent was obtained from research participants at baseline.
Methods and Materials: A total of 1295 volunteers free of major overt diseases, aged 65 to 79, were enrolled in 5 European countries(Italy, France, United Kingdom, Netherlands, and Poland). Interview, anthropometric measurements, whole-body DXA scans, blood, urine and faeces samples were taken at baseline/T1. Comparison of variables was performed using Wilcoxon rank-sum test. Correlation analysis was performed using Spearman rank test.
Results: DXA follow-up analysis revealed a significant decrease of fat mass(FM), fat mass/lean mass (FM/LM) and android FM/LM in the diet group of the Italian cohort. Plasma level changes of pro-inflammatory marker leptin were positively correlated with changes in FM (rho=0.179, p=0.048), LM (rho=0.201, p=0.026) andandroid/gynoid FM (rho=0.193, p=0.033), while the decrease of android FM/LM was negatively correlated with C-reactive protein plasma levels(rho=-0.433, p=0.0189).
Limitations: DXA scans were performed with different devices in the 5 centres.
Conclusion: BC markers may beuseful to predicta specific inflammatory risk profile in an elderly population during follow-up.
Funding for this study: This project was supported by the European Union’s Seventh Framework Program.

F. Bamberg; Tübingen/DE
An international randomised controlled trial of two interventions for reducing doses for computed tomography through audit feedback and sharing best practices
R. Smith-Bindman1, P. Chu1, Y. Wang1, R. Chung1, A. Einstein2, D. L. Miglioretti3; 1San Francisco/US 2New York/US 3Davis/US

Purpose: Few interventions for reducing radiation doses from CT have been studied.
Ethics committee approval: Approvals received.
Methods and Materials: We evaluated two interventions to optimize CT radiation effective dose using a randomized trial: a) simple audit comparing institutional doses with tailored recommendations; b) multicomponent intervention with audit plus 8-week educational course. We included 1,149,671 CT examinations from 103 institutions (6 countries) between November 2015 and August 2017. Mean effective dose and proportion of high-dose examinations within anatomic areas following each intervention were compared to baseline using hierarchical generalized linear models adjusting for temporal trends.
Results: Following the multicomponent intervention, mean dose and proportion of high dose examinations decreased significantly for all examination types (p<0.0001): abdomen examinations=2.7 mSv (19%) reduction in mean effective dose, 45% reduction in high-dose examinations; chest=0.9 mSv (11%) reduction in mean effective dose, 30% reduction of high-dose examinations; combined chest and abdomen=3.7 mSv, (20%) reduction in mean effective dose; 57% reduction of high-dose examinations; head=0.10 mSv (5%) reduction in mean effective dose, 19% reduction in high dose examinations. The simple audit also significantly reduced dose (p<0.05); however, the magnitudes were smaller than for the multicomponent intervention. Both interventions were more effective when combined with a 2-day in-person educational meeting.
Limitations: All institutions used dose monitoring software demonstrating an interest in dose optimisation.
Conclusion: Providing detailed feedback to institutions on their CT doses combined with actionable suggestions and education results in significant reductions in average CT doses and proportion of high-dose examinations.
Funding for this study: NIH

A. Trianni; Udine/IT
Prophylactic hydration to prevent contrast-induced nephropathy (AMACING): long-term results of a prospective, randomised, controlled, non-inferiority trial
E. C. Nijssen; Maastricht/NL

Purpose: The AMACING trial evaluated the cost and clinical effectiveness of current clinical practice guidelines on intravascular iodinated contrast material use. The study population included >90% patients marked as high risk by the guidelines. The results showed no prophylaxis to be non-inferior to standard prophylactic intravenous hydration in the prevention of contrast-induced nephropathy (CIN). The current paper presents the long-term data of the AMACING trial.
Ethics committee approval: The Maastricht University Medical Centre research ethics committee approved the study before first inclusion.
Methods and Materials: AMACING is a prospective, randomised, parallel-group, open-label, non-inferiority trial of patients at risk of CIN according to current guidelines, with eGFR30-59 mL/min/1·73 m² and undergoing elective procedure requiring iodinated contrast material administration. Between June 17, 2014, and July 17, 2016, 660 consecutive patients were randomly assigned (1:1) to receive no prophylaxis (n=332) or standard intravenous hydration with normal saline according to the guidelines (n=328). We excluded patients with eGFR<30 mL/min/1·73 m², previous dialysis, or no referral for intravenous hydration. Randomisation was stratified by predefined risk factors. Incidence of dialysis, mortality and renal function were registered up to 1 year post-contrast exposure. Subgroup analyses were performed based on pre-defined stratification risk factors. ClinicalTrials.gov, NCT02106234.
Results: Dialysis was recorded in 2/332 (0.60%) non-hydrated patients and in 2/328 (0.61%) hydrated patients. Absolute difference (no hydration vs hydration) -0·01% (95%CI -1.19 to 1.18; p=0.9909). 36/332 (10.84%) non-hydrated patients and 32/328 (9.76%) hydrated patients died within 365 days. Absolute difference (no hydration vs hydration) +1.01% (95%CI -3.55 to 5.72; p=0.6490).
Limitations: See Lancet 2017; 389:1312-22.
Conclusion: Assuming optimal contrast media administration, withholding prophylaxis for high-risk patients with eGFR>29 mL/min/1·73 m² might be considered without compromising patient safety.
Funding for this study: Stichting de Weijerhorst.

P. Aspelin; Stockholm/SE
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