3.1. Patients
This prospective study obtained institutional review board approval at the Affiliated Hospital of Guizhou Medical University (AHGMU). Sixty patients performed abdominal CT examination were enrolled into this study from April 2015 to March 2016 in AHGMU.
Inclusion criteria: 1, Patients suspected with renal mass or abdominal pain by clinic; 2, Patients age: 18 - 80 years; 3, Body mass index (BMI) of each patient was lower than 28 kg/m2.
Exclusion criteria: 1, Patients with renal mass after surgery; 2, Patients with the history of serious hypersensitivity reaction to contrast media; 3, Patients with renal insufficiency (estimated glomerular filtration rate (eGFR) < 60 mL/min/1.73m2); 4, Insufficient cardiac function; 5, Inability to hold breath to meet CTA requirement; 6, Patients with manifest thyrotoxicosis; 7, Pregnant women; 8, Patients who underwent other clinicals trial at the same time; 9, Inability to meet study requirements during experiments.
Randomization procedure: Assign 80 kVp or 120 kVp CT protocol to patients randomly according to the order of enrolment in this prospective study, the randomization procedure was based on the random number and block randomization by using SPSS software (version 23.0).
3.2. CT Protocols for Renal Artery CTA
Sixty consecutive patients underwent 128-slice multi-detector CT (MDCT) scanning (SOMATOM definition AS+, Siemens, Germany).
For the 80 kVp group, the settings were as follows: tube voltage 80 kVp, tube current 400 - 500 mAs, collimation 128 × 0.6mm, 1 mm slice thickness, 500 mm field of view (FOV);
For the 120 kVp group, the settings were: tube voltage 120 kVp, tube current and collimation were 200 - 250 mAs and 128 × 0.6 mm, 1 mm slice thickness, 500 mm FOV.
CT image datasets were reconstructed with SAFIRE at 80 kVp, and with FBP at 120 kVp. The acquisition followed craniocaudal direction, while breath holding, a series of unenhanced images of the upper abdomen were taken to evaluate the position of the renal region. The data of renal artery CTA were obtained at 25 - 30 seconds after administration of contrast medium (iopromide, 370 mgI/mL, 80 mL) injection at a flow rate of 3.0 mL/s by high pressure injector at the left superficial vein in the antecubital fossa. The scan parameters included a rotation time of 0.5 seconds, a pitch of 0.6 and a matrix of 512 × 512.
3.3. CT image Reconstruction
For renal artery CTA, all the CT images datasets were reconstructed at the workstation (Syngo CT Workplace VE40B), different iterative reconstruction strength levels and FBP algorithm were also reconstructed based on its original datasets. CT images with 1mm thickness and no intersection gap were generated for renal artery CTA. Multiplanar reformation (MPR) images and maximum intensity projection (MIP) images (including axial, sagittal, coronal image) were also generated, and these images were subsequently loaded into picture archiving and communication system (PACS) workstation (Syngo.plaza, Siemens) for evaluation by two experienced abdominal radiologists with a five-point scale.
3.4. Quantitative Assessment for Renal Artery CTA
With regards to the quantitative assessment of renal artery CTA, the signal intensity measurement was performed for each patient in corticomedullary phase contrast enhanced image datasets at workstation by means of Hounsfield units (HU). The CT attenuation of abdominal aorta (AO), right renal artery (RRA), left renal artery (LRA), erector spinae major (ESM), fat of subcutaneous abdominal wall (FSAW) and air were measured by placing the regions of interest (ROI) on the axial images. ROIs were drawn as large as the vessel lumen, and avoided the calcification of lumen wall or artifacts. Standard deviation (SD) of CT attenuation of air at the level of renal artery about 1 cm distal to the anterior abdominal skin was defined as background noise. Depending on the data of CT value, contrast to noise ratio (CNR) and signal to noise ratio (SNR) were calculated using the following formula:
Where CTvessels is the CT value of renal artery and other vessels, CTmuscle is the CT value of erector spinae major, SD is standard deviation of CT value of air.
3.5. Qualitative Assessment for Renal Artery CTA
All the MPR and MIP CTA images were evaluated by two experienced abdominal radiologists with 10 and 11 years experience who were blinded to the CT scanning parameters reviewed with a five-point scale.
Image quality was scored as follows:
For the overall image:
score of 1 = poor;
score of 2 = suboptimal;
score of 3 = diagnostic;
score of 4 = superior;
score of 5 = excellent.
Image quality was scored as follows for the sharpness of renal artery:
score of 1 = unacceptable anatomical structure and detail;
score of 2 = poor anatomical structure and detail;
score of 3 = acceptable anatomical structure and detail;
score of 4 = preferable sharpness of anatomical structure and detail;
score of 5 = ideal sharpness of anatomical structure and detail.
The detail of image quality was scored as follows for the segment of renal artery displayed in MPR and MIP image:
score of 1 = main renal artery;
score of 2 = first segment of renal artery;
score of 3 = second segment of renal artery;
score of 4 = third segment of renal artery;
score of 5 = four segment of renal artery.
Diagnostic confidence was also evaluated by a five-point scale:
score of 1 = very poor confidence,
score of 2 = suboptimal confidence,
score of 3 = acceptance confidence,
score of 4 = superior confidence,
score of 5 = excellent confidence.
The score of image quality ≥ 3 was satisfactory with clinical application.
3.6. Radiation Dose Assessment
Volume CT dose index (CTDIvol) and dose length product (DLP) were recorded according to the radiation dose report in the CT scanning. Effective dose (ED) and size-specific dose estimate (SSDE) were calculated for each patient according to the size of the body, including the size of lateral (LAT) dimension and anterior-posterior (AP) dimension at the level of the renal artery. Percentage dose reduction (DR) ratio was also computed in accordance with the following formula:
Where fsize32Xis the size-specific body radiation dose estimate conversion factor (
9), CTDI
120kVp is CTDI
vol valued at 120 kVp and CTD
I80kVp is CTDI
vol valued at 80kVp. SSDE
120kVp is considered as the mean value of SSDE in 120 kVp group, SSDE
80kVp is considered as the mean value in 120 kVp group, k refers to the body region, age and kV-specific dose conversion factor (
10).
3.7. Statistical Analysis
A statistical analysis was performed by utilizing SPSS software for Windows (version 23.0, SPSS Inc., Chicago, IL). Continuous variables were expressed as mean ± SD. The normality assumption of variables was conducted according to the Kolmogorow-Smirnov Z test. Categorized variable (gender) was analyzed by Chi-square test. Age was executed by the independent-sample T test. As for the 80 kVp-FBP group, 80 kVp-S4 and 120 kVp-FBP, the CT attenuation of AO, RRA, LRA, FSAW, AIR, ESM, SD, CNR and SNR of renal artery were analyzed by two-tailed paired-samples T test or independent-sample T test. Qualitative score was performed by Mann-Whitney U or Wilcoxon test among qualitative variables (overall image quality, vessels sharpness, segmental displayed in MIP or MPR, diagnostic confidence). As for the differences of subgroups (S1 - S5) at 80 kVp, quantitative assessment and qualitative assessment were both determined with the nonparametric Friedman’s test and performed pairwise comparisons, the significant difference level was adjusted. Radiation dose of the 80 kVp groups and 120 kVp group was tested by two-tailed, unpaired t-test.
Kappa analysis and percentage agreement were considered to evaluate the qualitative analysis and performed through MedCalc software (MedCalc 15.2.2, Mariakerke, Belgium). Definitions of inter-observer agreement on the basis of k value were as follows:
k values less than 0.20 were an indication of poor strength agreement,
k values between 0.21 and 0.40 were an indication of fair strength of agreement,
k values between 0.41 and 0.80 were an indication of moderate strength of agreement,
k values between 0.81 and 1.00 were an indication of very good strength of agreement.
P < 0.05 was considered as statistically significant.