2010;51:1624-1631, et al PLoS ONE sept 2014 Q. Section 3.6 CT parameters differ from Imaging Wisely guidelines Q. Concerns raised regarding collimator resolution requirements What do you mean by separate definition of caudate and putamen’ ‘Accurate FWHM < 10 mm : Manufacturer specified planar resolution vs. on-site measurement with I-123 test object Q. Dr. Klein suggested the need to tie the collimator resolution requirement to the SBR accuracy requirement in the phantom study specified in the profile. But difficult to do as there are several other factors that contribute to SBR accuracy. Q. 3.6.2 (Ancillary Equipment) and 3.6.3 (Phantom Imaging) that Zimmerman and John Dickson added to the Acquisition section (3.6) might be in the wrong plaqce, and possibly should be moved to 3.8 which is defined in the Table of Contents as Image QA. Closed Issues: The following issues have been considered closed by the biomarker committee. They are provided here to forestall discussion of issues that have already been raised and resolved, and to provide a record of the rationale behind the resolution. Q. Is this template open to further revisions? A. Yes. This is an iterative process by nature. Submit issues and new suggestions/ideas to the QIBA Process Cmte. Q. A. 1. Executive Summary Parkinsonism is a major health problem. Distinguishing Parkinson’s disease (PD) from other movement disorders that can mimic it has important implications for management. The goal of this QIBA Profile is to optimize the performance of Iodine-123 (123I) ioflupane single photon emission computed tomography (SPECT) for quantifying the concentration of regional cerebral dopamine transporters (DaT) in patients who are being evaluated for neurodegenerative disorders. The Claims (Section 2): This profile claims that compliance with its specifications will (1) produce cross sectional measurements of DaT that can distinguish patients with PD from matched controls, and (2) distinguish true biological change from measurement noise in clinical trials of patients with PD who will be studied longitudinally with 123I-ioflupane. Both claims are founded on observations that idiopathic
2010;51:1624-1631, et al PLoS ONE sept 2014 Q. Section 3.6 CT parameters differ from Imaging Wisely guidelines Q. Concerns raised regarding collimator resolution requirements What do you mean by ‘Accurate separate definition of caudate and putamen’ FWHM < 10 mm : Manufacturer specified planar resolution vs. on-site measurement with I-123 test object Q. Dr. Klein suggested the need to tie the collimator resolution requirement to the SBR accuracy requirement in the phantom study specified in the profile. But difficult to do as there are several other factors that contribute to SBR accuracy. Q. 3.6.2 (Ancillary Equipment) and 3.6.3 (Phantom Imaging) that Zimmerman and John Dickson added to the Acquisition section (3.6) might be in the wrong plaqce, and possibly should be moved to 3.8 which is defined in the Table of Contents as Image QA. Closed Issues: The following issues have been considered closed by the biomarker committee. They are provided here to forestall discussion of issues that have already been raised and resolved, and to provide a record of the rationale behind the resolution. Q. Is this template open to further revisions? A. Yes. This is an iterative process by nature. Submit issues and new suggestions/ideas to the QIBA Process Cmte. Q. A. 1. Executive Summary Parkinsonism is a major health problem. Distinguishing Parkinson’s disease (PD) from other movement disorders that can mimic it has important implications for management. The goal of this QIBA Profile is to optimize the performance of Iodine-123 (123I) ioflupane single photon emission computed tomography (SPECT) for quantifying the concentration of regional cerebral dopamine transporters (DaT) in patients who are being evaluated for neurodegenerative disorders. The Claims (Section 2): This profile claims that compliance with its specifications will (1) produce cross sectional measurements of DaT that can distinguish patients with PD from matched controls, and (2) distinguish true biological change from measurement noise in clinical trials of patients with PD who will be studied longitudinally with 123I-ioflupane. Both claims are founded on observations that idiopathic
001.QIBA_SPECT_Profile.v0.1_2016.04.05.docx