Clinical Trials in Radiology

Insights into Imaging, Apr 2018

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Clinical Trials in Radiology

Insights Imaging A - Clinical Trials in Radiology (CT) !" " " $ Wednesday, February 28 Purpose: Purpose: to examine the clinical outcome of MR-guided focused ultrasound (MRgFUS) and external-beam radiation therapy (EBRT) in patients with painful bone metastasis. Ethics committee approval: This study received institutional ethics committee approval. All patients provided written informed consent. Methods and Materials: Patients with solid tumors and one or more bone metastasis were included. Eligible patients were 18years of age, had radiologically-proven bone metastasis, could safely undergo both MRgFUS and radiotherapy and had pain scores 4(on 0-to-10 numeric rating scale). Participants were randomly assigned (1:1 ratio) to receive MRgFUS or EBRT. The primary endpoint was treatment response, defined as a reduction of 2points in worst pain by week-4, accompanied by a stable or reduced opioid dose, compared with baseline. Secondary endpoints assessed average pain, interference of pain with activities, breakthrough pain, mood, quality of life, and adverse events. Results: 233 patients (M:125,F:108) were enrolled and randomly assigned to MRgFUS(116) and EBRT(117). In the MRgFUS arm, 90 patients(77.6%) achieved the primary endpoint, compared with 92(78.6%) in the EBRT arm (adjusted odds ratio, 1.07;p=0.818). There were no significant differences in average pain, pain interference with activity, breakthrough pain, mood and quality of life between arms. Limitations: This work only considers short-term results, assessing primary and secondary outcomes within the first month after treatment. Conclusion: The role of MRgFUS in cancer-induced bone pain is comparable to EBRT, with the advantage of radiation-free and single-session procedure. MRgFUS is limited to non-spinal locations. Funding for this study: This study was conducted without any direct founding. Purpose: To evaluate the clinical benefit of using an electromagnetic navigation system during CT-guided interventional radiology procedures. Ethics committee approval: French Sud-Est V ethical committee (12/06/2013). Methods and Materials: This study included 455 patients between December 2013 and July 2015 across nine participating hospitals. After randomization, percutaneous procedures were carried out either under conventional CT guidance (CT group), or using the additional assistance of IMACTIS-CT® navigation system (NAV group). The primary outcome was evaluated by a blinded expert committee. It assessed the safety (number of serious adverse events), efficiency (number of targets reached) and performance (number of CT control acquisitions required to reach the target) of CT-guided interventions. Results: All patients (227 patients in NAV group and 228 patients in CT group) were included in the intention-to-treat analysis. Missing data of 4 patients were re-coded according to a worst-case scheme in disfavor of navigation. In noninferiority analysis, NAV system was as safe (CI90 [-0.03;0.032]; c=0.07) and as efficient (CI90 [-0.03;0.008]; - c=-0.1) as conventional guidance. The number of CT control demonstrated to be reduced using NAV (5[3;9]) vs CT (6[3;11]) p=0.015. Limitations: For 38 patients, the intervention was only partially achieved according to the initially randomized protocol: in most cases (33/38), radiologist went back to CT instead of NAV protocol, because of respiratory movements and/or lack of experience with the navigation system Conclusion: The use of an electromagnetic navigation system allows to reach the targets with fewer CT control acquisitions than with conventional CT guidance. Funding for this study: French Ministry of Health. Author Disclosures: I. Bricault: Advisory Board; member of the scientific advisory board of Imactis. 11:10 Discussant T. Penzkofer; Berlin/DE B-0187 11:15 Randomised clinical trial of portal vein embolisation using n-butylcyanoacrylate vs polyvinyl alcohol particles plus coils for liver hypertrophy before major hepatectomies J.H.M. Luz1, E. Coimbra1, T. Bilhim1, F.V. Gomes1, N.V. Costa1, M.T. Correia1, P. Luz2, E. Barroso1; 1Lisbon/PT, 2Rio de Janeiro/BR () Purpose: The aim of this study is to compare the efficacy of portal vein embolisation (PVE) using n-butyl-cyanoacrylate (NBCA) versus polyvinyl alcohol (PVA) particles plus coils in the induction of liver hypertrophy before major hepatectomies. Ethics committee approval: The hospital review board and local ethics committee approved the study protocol. Methods and Materials: This is a randomised clinical trial, single site. Eighty consecutive patients with resectable liver tumors and indication for preoperative PVE are randomised for one of two arms (40 patients in each arm). Primary endpoint is to compare the degree of hepatic hypertrophy, through computed tomography volumetry, at 14 and 28 days after PVE. Secondary endpoints are the comparative analysis of the two PVE methods (complications, cost, procedure time, contrast usage and r (...truncated)


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Clinical Trials in Radiology, Insights into Imaging, 2018, pp. 643-649, Volume 9, Issue 1, DOI: 10.1007/s13244-018-0625-2