Premium
Are Current Technical Exclusion Criteria for Clinical Trials of Magnetic Resonance–Guided High‐Intensity Focused Ultrasound Too Restrictive?
Author(s) -
Lau Lung W.,
Eranki Avinash,
Celik Haydar,
Kim AeRang,
Kim Peter C. W.,
Sharma Karun V.,
Yarmolenko Pavel S.
Publication year - 2020
Publication title -
journal of ultrasound in medicine
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.574
H-Index - 91
eISSN - 1550-9613
pISSN - 0278-4297
DOI - 10.1002/jum.15259
Subject(s) - medicine , magnetic resonance imaging , clinical trial , high intensity focused ultrasound , ultrasound , radiology , margin (machine learning) , intensity (physics) , inclusion and exclusion criteria , ablation , medical physics , pathology , physics , alternative medicine , quantum mechanics , machine learning , computer science
Certain technical criteria must be met to ensure the treatment safety of magnetic resonance–guided high‐intensity focused ultrasound. We retrospectively reviewed how our enrollment criteria were applied from 2014 to 2017 in a clinical trial of magnetic resonance–guided high‐intensity focused ultrasound ablation of recurrent malignant and locally aggressive benign solid tumors. Among the 36 screened patients between 2014 and 2017, more than one‐third were excluded for technical exclusion criteria such as the anatomic location and proximity to prosthetics. Overall, patients were difficult to accrue for this trial, given the incidence of these tumors. To increase potential accrual, screening exclusion criteria could be more generalized and centered on the ability to achieve an acceptable treatment safety margin, rather than specifically excluding on the basis of general anatomic areas.