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Eliminating Uncertainty in Coronary Artery Disease


3.1 Clinical Study EU

"In order to approve the MedTrace solution as medical device, the company needs to carry out a minor clinical study using 15O-water in cardiac patients to prove safety and efficacy. Part of this study is to purchase already existing data from Amsterdam University Medical Centers from a recent similar clinical trial. In parallel the clinical study will be prepared (study protocol, site recruitment, clinical trial agreements and patient recruitment) End deliverable is ""last patient scanned""."

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Cardiac viability PET using combined parametric 15O-water blood flow/18F-FDG metabolism compares well with 82Rb/18F-FDG

Author(s): Mette Kjaerulff, Simon Madsen, Kirsten Bouchelouche, Lars Gormsen and Lars Tolbod
Published in: Journal of Nuclear Medicine, May 2021, 62 (supplement 1), 2021, Page(s) 1632
Publisher: SNMMI