Protocol Design Physician / Medical Physicist Medical Physicist shall ensure that CT techniques protocols are designed such that dose exposure is the lowest radiation dose necessary to achieve the objective. Protocols defined by Gently and Image Wisely should be used where feasible. The protocol shall be recorded and documented. Technologist The technologist shall ensure that the CT dose conforms to the dose prescribed by the supervising physician or protocol. 3.7. Image Data Reconstruction 3.7.2 Parameter Actor Requirement SPECT Image Reconstruction Study Sponsor and Medical Physicist and imaging center and its applicable standard operating procedures The key SPECT reconstruction parameters (algorithm, iterations, smoothing, field of view, voxel size) shall be specified in a manner that is expected to produce comparable results regardless of the scanner make and model. The key SPECT image reconstruction parameters shall be specified according to pre-determined harmonization parameters. Technologist The key SPECT reconstruction parameters (algorithm, iterations, smoothing, field of view, voxel size) shall be followed and set as specified in order to produce comparable results regardless of the scanner make and model. Matrix/Voxel size Technologist The Technologist shall perform the image reconstruction such that the matrix, slice thickness, and reconstruction zoom shall yield a voxel size of < 4 mm (same as projection bin size) in all three dimensions, although not necessarily isotropic. The final size shall not be achieved by re-binning, etc., of the reconstructed images. Correction: Attenuation Technologist Uniform or non-uniform attenuation correction shall be included in the reconstruction. For uniform correction a narrow beam attenuation coefficient of 0.148 cm-1 shall be used when scatter correction is included while
This activity describes criteria and procedures related to clinically interpreting the measurements and images that are necessary to reliably meet the Profile Claim. 3.11.2 Parameter Actor Requirement count sufficiency nuclear medicine specialist or nuclear radiologist Shall confirm sufficient counts have been acquired to reconstruct the images properly conspicuous margins Shall confirm the margins are sufficiently conspicuous and have not been degraded by excessive patient motion. Excessive motion Shall confirm that image quality has not been degraded by excessive patient motion. Proper positioning in FOV confirm that basal ganglia are in the field of view by assessing where the top of the head is. artifacts ensure assessment is not confounded by ring artifacts, artifacts related to too large a radius for COR (i.e., should be <15 cm, or edge artifacts Mis-registration of SPECT/CT or discordance of Chang’s Shall ensure that the attenuation map is visually registered to the CT map within one reconstructed voxel dimension. Parameter Actor Requirement Place VOI Technologist or image analysis specialist For SBR, shall cause to have placed volumes of interest (VOI) on structures of interest and appropriate reference tissue. VOIs include caudate, anterior putamen, and posterior putamen on each side of brain. Calculate measurand Technologist or image analysis specialist Shall calculate time-point measurand (SBR or %dose/mL) Certify VOI Qualified physician Shall either (1) agree with region boundaries, (2) reject boundaries and return for reprocessing, or (3) make revisions “on the fly” as indicated. Certify measurand Qualified physician Shall either (1) agree with region boundaries, (2) reject boundaries and return for reprocessing, or (3) make revisions “on the fly” as indicated. classification Qualified physician Claim 1: interpret measurand as consistent with, or not consistent with, Parkinson’s disease. Claim 2: interpret measurand a consistent with a value of X +/- y, where x is the measured value, and y is the confidence interval described in Section 2 under Claim 2