1. Value of ultra-high field MRI in patients with suspected focal epilepsy and negative 3 T MRI (EpiUltraStudy): protocol for a prospective, longitudinal therapeutic study
- Author
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van Lanen, R. H. G. J., Wiggins, C. J., Colon, A. J., Backes, W. H., Jansen, J. F. A., Uher, D., Drenthen, G. S., Roebroeck, A., Ivanov, D., Poser, B. A., Hoeberigs, M. C., van Kuijk, S. M. J., Hoogland, G., Rijkers, K., Wagner, G. L., Beckervordersandforth, J., Delev, D., Clusmann, H., Wolking, S., Klinkenberg, S., Rouhl, R. P. W., Hofman, P. A. M., Schijns, O. E. M. G., RS: MHeNs - R3 - Neuroscience, Psychiatrie & Neuropsychologie, MUMC+: MA AIOS Neurochirurgie (9), Scannexus, RS: MHeNs - R1 - Cognitive Neuropsychiatry and Clinical Neuroscience, Beeldvorming, MUMC+: DA BV Klinisch Fysicus (9), RS: FPN CN 11, Multiscale Imaging of Brain Connectivity, MRI, RS: FPN CN 5, MUMC+: DA BV Medisch Specialisten Radiologie (9), RS: CAPHRI - R2 - Creating Value-Based Health Care, MUMC+: KIO Kemta (9), Epidemiologie, MUMC+: MA Niet Med Staf Neurochirurgie (9), MUMC+: MA Med Staf Spec Neurochirurgie (9), RS: GROW - R2 - Basic and Translational Cancer Biology, MUMC+: DA Pat Pathologie (9), Klinische Neurowetenschappen, and MUMC+: MA Med Staf Spec Neurologie (9)
- Subjects
SELECTION ,Drug Resistant Epilepsy ,SURGERY ,UHF MRI ,ILAE COMMISSION ,CONSENSUS CLASSIFICATION ,PROPOSAL ,Epilepsy surgery ,Humans ,Radiology, Nuclear Medicine and imaging ,Longitudinal Studies ,Prospective Studies ,INTRACTABLE EPILEPSY ,Child ,Epilepsy ,MEG ,SURGICAL OUTCOMES ,7 T ,Magnetic Resonance Imaging ,9.4 T ,CORTICAL DYSPLASIA ,Treatment Outcome ,Epilepsies, Partial ,Neurology (clinical) ,Cardiology and Cardiovascular Medicine ,HOC TASK-FORCE - Abstract
Purpose Resective epilepsy surgery is a well-established, evidence-based treatment option in patients with drug-resistant focal epilepsy. A major predictive factor of good surgical outcome is visualization and delineation of a potential epileptogenic lesion by MRI. However, frequently, these lesions are subtle and may escape detection by conventional MRI (≤ 3 T). Methods We present the EpiUltraStudy protocol to address the hypothesis that application of ultra-high field (UHF) MRI increases the rate of detection of structural lesions and functional brain aberrances in patients with drug-resistant focal epilepsy who are candidates for resective epilepsy surgery. Additionally, therapeutic gain will be addressed, testing whether increased lesion detection and tailored resections result in higher rates of seizure freedom 1 year after epilepsy surgery. Sixty patients enroll the study according to the following inclusion criteria: aged ≥ 12 years, diagnosed with drug-resistant focal epilepsy with a suspected epileptogenic focus, negative conventional 3 T MRI during pre-surgical work-up. Results All patients will be evaluated by 7 T MRI; ten patients will undergo an additional 9.4 T MRI exam. Images will be evaluated independently by two neuroradiologists and a neurologist or neurosurgeon. Clinical and UHF MRI will be discussed in the multidisciplinary epilepsy surgery conference. Demographic and epilepsy characteristics, along with postoperative seizure outcome and histopathological evaluation, will be recorded. Conclusion This protocol was reviewed and approved by the local Institutional Review Board and complies with the Declaration of Helsinki and principles of Good Clinical Practice. Results will be submitted to international peer-reviewed journals and presented at international conferences. Trial registration number www.trialregister.nl: NTR7536.
- Published
- 2022
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