| Part Ⅰ: Insight NM/CT Pro SPECT/CT safety and effectiveness validation studiesObjective In this study,the safety and effectiveness of the Insight NM/CT Pro SPECT/CT imaging system was verified through clinical validation of the primary evaluation index of acceptable clinical image quality,the secondary evaluation index of common functions of the device,ease of use of the machine,satisfaction with the stability of the machine and the safety evaluation of recorded adverse events and serious adverse events,and it is clear that the effectiveness of this device fully meets the requirements of clinical application,has superior safety and reliability,and can be promoted to the clinic.Methods Subjects who volunteered to participate in this clinical trial from July 2022 to October 2022 were selected,explained about the trial and signed an informed consent form,and entered this trial after meeting the clinical validation screening criteria.Under the premise of ensuring the safety of the subjects and the scientific validity of the clinical trial,both planar and tomographic imaging modalities were used for clinical validation,and the endocrine,circulatory,skeletal,respiratory and urinary systems were visualised according to the method of visualisation of each system,and the validity of the images was evaluated along with the safety of the machine.The main evaluation index is the clinical image quality acceptability rate,the image quality evaluation grade is divided into four levels: 0,1,2 and 3,and a score of ≥2 is clinically acceptable.The secondary evaluation criteria are based on the clinical operators’ evaluation of the operation of the equipment in each case(including the common functions of the equipment,ease of use,stability and safety of the equipment),and the results are classified as "satisfactory,fair and unsatisfactory".Safety evaluation criteria In order to collect reliable safety data,all adverse events and serious adverse events observed during the trial should be recorded.Results 1.79 patients(mean age 53.82 ± 13.98 years)were visualised on Insight NM/CT Pro SPECT/CT equipment,of whom 40(50.63%)were male and 39(49.37%)were female.In 36 cases of planar imaging,the image quality was assessed as acceptable in 35 cases;in 43 cases of tomographic imaging,the image quality was assessed as acceptable in 42 cases.The acceptance rates of clinical image quality for the two imaging modalities were 97.22% and97.67% respectively,with lower 95% CI limits of 85.47% and 87.71% respectively,which were higher than the target value of 83.00%,demonstrating that the effectiveness of the device meets the requirements of clinical application.2.The results of the clinical operators’ evaluation of the operation of the equipment during the visualisation of 79 patients were counted.The satisfaction rate was 100%,with 79 cases in which the common functions of the equipment,the ease of use of the equipment and the stability of the machine were evaluated.3.No adverse events or serious adverse events occurred when the clinical operators performed imaging operations on 79 patients,and the safety performance was good.Conclusion This study validates the safety and effectiveness of the Insight NM/CT Pro SPECT/CT by evaluating the image quality and equipment operation of the multi-system imaging.The results prove that the effectiveness of this device fully meets the requirements of clinical application,the tissue structure of the image is clearly displayed,the lesion and normal tissue can be better distinguished,the common functions of the device are complete,the operation is convenient,the system is stable during scanning,the safety is superior and reliable,it can fill the gap of domestic SPECT/CT,promote the process of localization of high-end medical equipment,suitable for medical research and bring convenience and benefit to patients who need to perform such examinations.Part Ⅱ Insight NM/CT Pro SPECT/CT in qualitative and quantitative studies in bone metastasesObjective Taking the imported equivalent SPECT/CT machine as the "reference standard",the differences and consistency between the whole-body bone SPECT/CT quantitative tomography and the local bone SPECT/CT quantitative tomography of Insight NM/CT Pro SPECT/CT and the former were evaluated from both qualitative diagnosis and quantitative analysis,and the diagnostic value of the quantitative parameters SUVmax,SUVmin and SUVavg were analyzed to clarify the feasibility of Insight NM/CT Pro SPECT/CT in the clinical examination of bone metastases.Methods Patients with positive findings on whole-body skeletal imaging at the Department of Nuclear Medicine of the Affiliated Hospital of Inner Mongolia Medical University from August 2022 to February 2023 were selected for examination using imported equivalent SPECT/CT machine and Insight NM/CT Pro SPECT/CT.30 patients underwent whole-body bone imaging and 30 patients underwent local bone SPECT/CT quantitative tomography(some patients underwent both whole-body and local imaging),and signed informed consent forms.The qualitative diagnosis was made by counting the area and number of positive lesions on whole-body bone imaging,and the quantitative analysis was evaluated using the quantitative local fusion tomography parameter SUV.The qualitative diagnosis and quantitative analysis of all patients on the 2 machines were tested for consistency by ICC and Bland-Altman analysis.The diagnostic value of the quantitative parameters SUVmax,SUVmin and SUVavg for bone metastases was also analysed by ROC curve analysis.Results 1.30 patients in the qualitative diagnostic study underwent whole-body bone imaging and a total of 87 positive lesions were found to be involved in the Insight NM/CT Pro SPECT/CT scan,including 3 in the skull,23 in the spine,22 in the chest,24 in the pelvis and15 in the extremities;the imported equivalent SPECT/CT machine found a total of 87 positive lesions to be involved in the skull,23 in the spine,22 in the chest,24 in the pelvis and 15 in the extremities.There was good agreement between the two devices in finding an equal number of lesions in the same locations.2.A total of 187 lesions were detected in the 30 patients studied for quantitative analysis,and the ICC values for the quantitative parameters SUVmax,SUVmin and SUVavg were 0.959,0.589 and 0.909 for local SPECT/CT bone quantitative tomography on the Insight NM/CT Pro SPECT/CT and imported equivalent SPECT/CT machines,respectively.The differences were statistically significant(p-values <0.001).The differences in SUVmax,SUVmin and SUVavg measured on the two machines were generally within the 95% confidence interval and were in good agreement.3.The quantitative parameter SUVmax was better than SUVmin and SUVavg in the spine,pelvis and extremity groups,which had better diagnostic value.The sensitivity was 87.4% and specificity was99.97% for SUVmax≥13.09 in the spine group and 89.5% and 81.2% for SUVmax≥9.87 in the pelvis group,which can be used to differentiate the diagnosis of bone metastases from normal sites.Conclusions 1.The Insight NM/CT Pro SPECT/CT has good agreement with its imported equivalent in the qualitative diagnosis of the area involved in the detected lesion in bone metastases,and the images are clear without quality problems such as low image information,high statistical noise and generated image artefacts.2.The quantitative assessment of the parameters SUVmax,SUVmin and SUVavg in bone metastases measured by the Insight NM/CT Pro SPECT/CT is in good agreement with its imported equivalent.The Insight NM/CT Pro SPECT/CT uses a line tracing reconstruction method that not only achieves good imaging performance at high speed but is also equivalent to imported equipment.3.The quantitative parameter SUVmax was better than SUVmin and SUVavg in the spine,pelvis and limb groups,and had better diagnostic value.SUVmax≥13.09 in the spine group and SUVmax≥9.87 in the pelvis group can be used to differentially diagnose bone metastases from normal sites. |
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