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 Shall confirm sufficient counts have been acquired to reconstruct count sufficiency the images properly conspicuous Shall confirm the margins are sufficiently conspicuous and have margins not been degraded by excessive patient motion. Shall confirm that image quality has not been degraded by Excessive motion excessive patient motion. nuclear medicine Proper confirm that basal ganglia are in the field of view by specialist or positioning in assessing where the top of the head is. nuclear FOV radiologist ensure assessment is not confounded by ring artifacts, 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 Shall ensure that the attenuation map is visually registered to the discordance of CT map within one reconstructed voxel dimension. Chang’s Parameter Actor Requirement For SBR, shall cause to have placed volumes of interest (VOI) on Technologist or structures of interest and appropriate reference tissue. VOIs Place VOI image analysis include caudate, anterior putamen, and posterior putamen on specialist each side of brain. Technologist or Calculate image analysis Shall calculate time-point measurand (SBR or %dose/mL) measurand specialist Qualified Shall either (1) agree with region boundaries, (2) reject Certify VOI physician boundaries and return for reprocessing, or (3) make revisions “on the fly” as indicated. Qualified Shall either (1) agree with region boundaries, (2) reject Certify physician boundaries and return for reprocessing, or (3) make revisions “on measurand the fly” as indicated. Qualified Claim 1: interpret measurand as consistent with, or not consistent physician with, Parkinson’s disease. classification 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
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
002.QIBA_SPECT_Profile_Checklist_Extract.2016_10_31.docx