Hristova Ivalina, Boellaard Ronald, Galette Paul, Shankar Lalitha K, Liu Yan, Stroobants Sigrid, Hoekstra Otto S, Oyen Wim J G
Department of Nuclear Medicine, Radboud University Medical Centre, Geert Grooteplein-Zuid 10, 6525 GA, Nijmegen, The Netherlands.
European Organization for Research and Treatment of Cancer, Imaging Group, Brussels, Belgium.
EJNMMI Phys. 2017 Sep 18;4(1):23. doi: 10.1186/s40658-017-0190-7.
To date, there is no published detailed checklist with parameters referencing the DICOM tag information with respect to the quality control (QC) of PET/CT scans. The aims of these guidelines are to provide the know-how for effectively controlling the quality of PET/CT scans in multicenter studies, to standardize the QC, to give sponsors and regulatory agencies a basis for justification of the data quality when using standardized uptake values as an imaging biomarker, to document the compliance with the imaging guidelines, to verify the per protocol population versus intent to treat population, and to safeguard the validity of multicenter study conclusions employing standardized uptake value (SUV) as an imaging biomarker which is paramount to the scientific community. Following the proposed guidelines will ensure standardized prospective imaging QC of scans applicable to most studies where SUVs are used as an imaging biomarker. The multitude of factors affecting SUV measurements when not controlled inflicts noise on the data. Decisions on patient management with substantial noise would be devastating to patients, ultimately undermine treatment outcome, and invalidate the utility of SUV as an imaging biomarker usefulness. Strict control of the data quality used for the validation of SUV as an imaging biomarker would ensure trust and reliability of the data.
迄今为止，尚无已发表的详细检查表，其中包含涉及PET/CT扫描质量控制（QC）的DICOM标签信息的参数。这些指南的目的是提供在多中心研究中有效控制PET/CT扫描质量的专业知识，使质量控制标准化，为赞助商和监管机构在将标准化摄取值用作成像生物标志物时提供数据质量合理性依据，记录对成像指南的遵守情况，核实符合方案人群与意向性治疗人群，以及保障采用标准化摄取值（SUV）作为成像生物标志物的多中心研究结论的有效性，这对科学界至关重要。遵循所提议的指南将确保适用于大多数将SUV用作成像生物标志物的研究的扫描的标准化前瞻性成像质量控制。在未得到控制时，影响SUV测量的众多因素会给数据带来噪声。基于存在大量噪声的数据进行患者管理决策将对患者造成灾难性后果，最终破坏治疗结果，并使SUV作为成像生物标志物的效用无效。严格控制用于验证SUV作为成像生物标志物的数据质量将确保数据的可信度和可靠性。
