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Clinical Trials in Radiology

2018; Springer Nature; Volume: 9; Issue: S1 Linguagem: Inglês

10.1007/s13244-018-0625-2

1869-4101

M Dewey, Alessandro Napoli, R. Scipione, Andrea Leonardi, Hans‐Peter Erasmus, Susan Dababou, Cristina Marrocchio, C Catalano, Rome, Alessandro Posa, Roberto Iezzi, F Carchesio, Andrea Veltri, Riccardo Cioni, Riccardo Manfredi, L. Bonomo, A Mounier, R.C. Rouchy, Marco Medici, E. Chipon, Alexandre Moreau‐Gaudry, Ivan Bricault, José Hugo Mendes Luz, Élia Coimbra, Tiago Bilhim, Filipe Veloso Gomes, Nuno Vasco Costa, M Correia, Paulo Luz, Eduardo Barroso, Amélie Carolina Hesse, Antonia Zapf, Jan Liman, Jens Fiehler, Anastasios Mpotsaris, Peter Schramm, Ansgar Berlis, Michael Knauth, Marios‐Nikos Psychogios, Riccardo Marano, Laura Elzenbeck, Sebastian S. Feger, Peter Martus, Nina Rieckmann, Karl Stangl, Marek Adam, Henryk Dreger, Antje Beling, Elke Zimmermann, M. Rief, Benjamin J.W. Chow, Pál Maurovich‐Horvat, Michael Laule,

Radiomics and Machine Learning in Medical Imaging

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.