Clinical Low-Dose Computed Tomography Application for Urinary Calculi Detection Based on In Vitro Model
Article information
Abstract
Background
Low-dose computed tomography (LDCT) is gaining attention for its potential to reduce radiation exposure in clinical imaging, particularly for urinary calculi detection. However, the optimal dose and clinical efficacy of LDCT remain to be fully validated. This study aimed to identify the optimal LDCT scanning parameters using an in vitro model, then apply these findings to clinical diagnosis, and assess the efficacy of the optimal dose in detecting urinary calculi.
Materials and Methods
Six distinct compositions of human urinary calculi were selected for analysis, with sizes of 1, 2, 4, and 7 mm. Stones of the same composition but different sizes were transplanted into a pork kidney, followed by computed tomography (CT) scans using decreasing doses of 120, 100, 80, 60, and 40 mAs. These scans were used to analyze the presence, size, and location of the transplanted urinary calculi. Subsequently, 150 patients with clinically suspected urinary calculi were scanned using a conventional CT dose of 120 kVp and 250 mAs, as well as the optimal low-dose parameters of 120 kVp and 60 mAs (obtained from in vitro model). Finally, the computed tomography dose index volume (CTDIvol), dose length product (DLP), and effective dose (ED) were recorded for each patient.
Results and Discussion
Using the in vitro model scanning, stones of varying compositions were detected with 100% accuracy under the prescribed radiation doses. A total of 150 patients with suspected urinary calculi were included in the analysis. Both conventional-dose computed tomography (CDCT) and LDCT detected a total of 285 urinary calculi. No significant differences in image quality were observed between LDCT and CDCT (p>0.05). However, there was a substantial reduction in the CTDIvol, DLP, and ED by 81%, 79%, and 79%, respectively (p<0.05).
Conclusion
LDCT shows promise in clinical practice, offering a significant reduction in radiation exposure without compromising diagnostic accuracy.
Introduction
Urinary calculi represent one of the most prevalent disorders associated with the urinary system, with a worldwide incidence ranging from 1% to 20% [1]. In the United States, the lifetime prevalence of urinary calculi is estimated at 10%–15% [2], while approximately 6.4% of patients in China are affected by this condition [3]. Due to rising rates of unhealthy diet and lifestyle choices, the incidence and recurrence of urinary calculi are increasing, with a recurrence rate of up to 52% within 10 years [4], particularly among children and young adults [5, 6]. Several methods are available for detecting urinary calculi. Historically, the primary imaging techniques included plain film of kidneys, ureters, and bladder (KUB), intravenous pyelography, and ultrasound (US). However, computed tomography (CT) has gained significant popularity for urinary calculi detection due to its rapid scanning capabilities, high resolution, and three-dimensional reconstruction [7]. Consequently, CT is now widely used for the imaging the diagnosis of urinary calculi. Despite its effectiveness, patients often undergo multiple CT scans for accurate diagnosis and disease evaluation. While conventional-dose computed tomography (CDCT) provides satisfactory diagnostic results, it poses considerable radiation risks [8]. Repeated CT exposures can potentially harm the human body and increase cancer risk [9]. To balance diagnostic quality with minimal radiation exposure, the medical research community must revisit this issue in line with the ‘as low as reasonably achievable (ALARA)’ principle [10].
Low-dose computed tomography (LDCT) has recently emerged as a method to reduce patient radiation exposure, in line with the ALARA principle. Initially, LDCT was primarily used for lung cancer screening [11, 12]. However, with its growing application, an increasing number of studies have investigated its efficacy in urology. Several approaches, such as decreasing tube current or using a tin filter, have been explored to reduce the CT radiation dose [13, 14]. Numerous studies have demonstrated that LDCT is an effective tool for diagnosing urinary calculi while reducing the effective radiation dose [14, 15]. However, radiation dose reduction is often accompanied by increased image noise and reduced image quality, which may negatively impact stone evaluation.
This study aimed to assess the feasibility of applying optimal low doses, derived from in vitro models, in clinical settings. The integration of a laboratory model with clinical validation strengthened the evidence for the feasibility and practicality of the optimal LDCT criteria in detecting urinary calculi in clinical practice.
Materials and Methods
1. In Vitro Model Scanning
1) In vitro modeling
Six distinct compositions of human urinary calculi—whedellite, uricacid, cystine, struvite, apatite, and brushite—were obtained from the urology department of the participating hospital between July and December 2022. Four sizes (1, 2, 4, and 7 mm) of each of the six urinary calculi were collected, resulting in a total of 24 stones (Fig. 1A). Meanwhile, a pork kidney with a smooth surface was acquired, submerged in normal saline (NaCl 0.9%), and manually compressed to eliminate internal gas as much as possible. The kidney was sliced along the renal pelvis and scanned to ensure the absence of scattered calcifications. Human urinary calculi of the same composition but varying sizes were then independently implanted into the renal pelvis (Fig. 1B and 1C). The experiments were conducted collaboratively by two radiology technologists, a specialist radiologist, and two urology residents. To ensure consistency, the procedure was repeated in a standardized manner for each stone.
Pork kidney model. (A) Various compositions of human calculi, each available in four sizes: 1, 2, 4, and 7 mm, (B) 1 mm stone located in the renal pelvis, 2 mm stone in the renal pelvis, 4 mm stone in the lower calyx, and 7 mm stone in the upper calyx, (C) pork kidney during computed tomography scanning.
2) Scanning methods
CT scans were performed using a 64-slice multi-detector CT scanner (Optima CT660; GE Healthcare) with a pitch of 1.0, rotation time of 0.5 second, slice thickness of 5 mm, tube voltage of 120 kVp, and tube loading set at 120, 100, 80, 60, and 40 mAs.
3) Image analysis
All CT images were independently analyzed by two radiologists with 8 years of experience, who were blinded to the stone composition and scanning conditions. The primary endpoint was to determine whether the four stones of each composition were successfully detected under varying scanning conditions.
2. Clinical Research
1) Participants
A total of 150 adult patients, either suspected of having or confirmed to have urinary calculi, who underwent CT examination between January 2022 and June 2023, were included in the study. Patients with a history of kidney surgery or those who were pregnant were excluded. Patients presenting with symptoms such as flank pain were initially scheduled for CDCT scans. For patients in whom urinary calculi were detected on the CDCT scan, an additional LDCT scan was performed at the site of the stone. The study was approved by the institutional ethics committee, and all participants provided informed consent, fully understanding the potential risks associated with the additional radiation exposure.
2) Scanning protocol
Using a 64-slice multi-detector CT scanner, scans were conducted from the upper kidney region to the lower margin of the pubic symphysis. Patients were initially scanned using CDCT. Upon stone detection, a LDCT scan was performed at the stone site. CDCT was performed using the following parameters: tube voltage of 120 kVp, tube loading of 250 mAs, pitch of 1.0, rotation time of 0.5 second, and slice thickness of 5 mm. LDCT utilized the optimal low-dose scanning parameters identified in the in vitro model, with tube loading set at 60 mAs, while the other parameters remained the same as CDCT. Automatic exposure control was applied based on the patient’s body mass index (BMI). Images with a slice thickness of 0.625 mm were reconstructed using the filtered back projection (FBP) method. After reconstruction of axial and coronal images, the images were transferred to a workstation for further processing. Finally, the appropriate window level and width were adjusted for image analysis.
3) Image analysis
All CT images were independently analyzed by two radiologists with 8 years of experience, who were blinded to patient information and CT protocol parameters. The analysis focused on the quantity, size, and location of the stones. Additionally, the image quality, noise, and diagnostic reliability were assessed. Image quality was scored on a scale of 1 to 5, defined as follows: 1, poor quality, not suitable for diagnosis; 2, suboptimal quality, unacceptable for diagnosis; 3, acceptable quality, permitting diagnosis; 4, good quality; and 5, excellent quality. Images with a score of ≥3 were used for diagnosis. Image noise was rated on a scale of 1 to 3, as follows: 1, minimal; 2, acceptable; and 3, too extensive to permit diagnosis. Lastly, diagnostic confidence was rated on a scale of 1 to 3, with the following definitions: 1, no confidence; 2, confidence with reservations; and 3, highly confident.
4) Radiation dose
The computed tomography dose index volume (CTDIvol), dose length product (DLP), and effective dose (ED) were compared between the two cohorts. The ED was calculated using the formula: ED=DLP×k, where k is the conversion factor (0.015) for the abdomen, as specified by the European recommendation for CT quality standards.
5) Statistical analysis
Data analysis was performed using SPSS version 17.0 (SPSS Inc.). Quantitative data are presented as mean±standard deviation, while qualitative data are presented as numbers and percentages. Inter-group variations were assessed using the paired t-test and Mann-Whitney U test. The intraclass correlation coefficient (ICC) for stone size measurements obtained by CDCT and LDCT was also calculated. Statistical significance was set at p<0.05.
Results
1. Patient Demographics
A total of 150 patients were recruited from the participating hospital between January 2022 and June 2023. The patients presented with the following complaints: flank pain (114 [76%]), hematuria (55 [36.67%]), dysuria (81 [54%]), and vomiting (34 [22.67%]). Among the participants, 98 were male and 52 were female, with a mean age of 47.7±8.3 years (range, 20–75 years) and a mean BMI of 23.24±3.67 kg/m2 (range, 16.90–33.75 kg/m2).
2. Stone Detection in the In Vitro Model Scan
A total of 24 urinary calculi, with diameters of 1, 2, 4, and 7 mm, were detected using tube voltage of 120 kVp and tube loading of 120, 100, 80, 60, and 40 mAs, respectively. The detection rate was 100%. However, at 40 mAs, the image signal-to-noise ratio was poor, leading to use of 60 mAs in the clinical trial. Fig. 2 shows images of 1 mm stones of different composition scanned at 60 mAs.
3. Stone Diagnoses in Clinical Studies
As shown in Table 1, no statistically significant differences were observed between CDCT and LDCT in terms of stone location and number. Both CDCT and LDCT detected a total of 285 stones, with 148 stones located in the kidney and 137 in the ureter. The maximum diameter of the stones ranged from 1 mm to 20 mm. The ICC analysis demonstrated a strong correlation between the length, width, and height measurements of stones obtained by CDCT and LDCT (Table 2), indicating that both methods exhibited excellent consistency in assessing the size of urinary calculi. Fig. 3 presents the reconstructed images from both CDCT and LDCT scans.
Images of urinary calculi. A stone in the left renal calyx identified by conventional-dose computed tomography (CDCT; 120 kVp, 250 mAs; size: 3.2 mm×2.9 mm×2.5 mm) (A) and low-dose computed tomography (LDCT; 120 kVp, 60 mAs; size: 3.1 mm×2.9 mm×2.6 mm) (B). A stone in the right lower ureter identified by CDCT (size: 4.5 mm×6.3 mm×5.2 mm) (C) and LDCT (size: 4.4 mm×6.4 mm×5.3 mm) (D). The white arrows indicate the location of the stone.
4. Image Quality Evaluation for CDCT and LDCT
Following the reconstruction of CDCT and LDCT images, the image quality, noise, and diagnostic confidence were evaluated by radiologists. Based on their assessment, the image noise was comparable between the two cohorts, and no significant differences were observed in image quality (p>0.05) (Table 3).
5. Radiation Dose Comparison between CDCT and LDCT
The mean CTDIvol, DLP, and ED of CDCT were 18.32± 3.60 mGy, 486.41±78.72 mGy·cm, and 5.94±1.34 mSv, respectively. The mean CTDIvol, DLP, and ED of LDCT were 3.43±0.83 mGy, 101.33±65.41 mGy·cm, and 1.23±0.78 mSv, respectively. Compared to CDCT, the LDCT radiation dose was significantly reduced (p<0.05) (Table 4).
Discussion
LDCT has been generally limited in clinical applications due to its poor image quality and high noise levels. In the present study, our in vitro model identified 60 mAs as the optimal dose, demonstrating the highest detection rate. Therefore, this dose was used in the clinical trials. Compared to CDCT, LDCT did not significantly affect clinical diagnosis outcomes, indicating that LDCT is feasible for use in clinical settings. Significant differences in CTDIvol, DLP, and ED were observed between the two groups (p<0.05). Based on these results, although LDCT substantially reduced radiation exposure, the image quality and diagnostic accuracy were maintained. Together, these findings confirm the feasibility of LDCT in clinical applications. It should be noted; however, that this conclusion is specific to the evaluation of urinary calculi, as image quality may vary when assessing other pathologies.
Urinary calculi are commonly found in the kidneys, ureters, urinary bladder, and urinary tract [16], and they typically manifest as hematuria, flank pain, abdominal pain, nausea, and vomiting [17]. Urinary calculi can cause significant pain and lead to dysuria, which, if left untreated, may progress to anuria and uremia. Therefore, early detection is critical for improving patient outcomes. Unfortunately, traditional diagnostic methods have a relatively high missed diagnosis rate. While KUB is easy to perform, its diagnostic accuracy is relatively low (specificity 76%). US can preliminarily detect hydronephrosis in the urinary system, but it is less effective in detecting urinary calculi (specificity 53%). In contrast, CT significantly improves image resolution and diagnostic accuracy, with a specificity and sensitivity exceeding 95% [18]. However, with the widespread use of CT, radiation exposure has markedly increased. Therefore, it is essential to maintain high image quality while minimizing radiation dose.
Several studies [19–21] have shown that LDCT, compared to CDCT, provides similar stone detection rates while significantly reducing radiation exposure, with no significant difference in image quality. In clinical practice, instruments from various manufacturers, including GE, Siemens, and Philips, are used for LDCT-based detection of urinary calculi. However, the models and internal structures of these machines vary, meaning there is currently no unified standard for LDCT-based assessment.
The primary approaches to reducing radiation exposure in clinical practice include increasing pitch, reducing tube voltage, and lowering tube current [22–24]. Increasing pitch, however, increases the risk of missed small lesion. Reducing tube voltage can drastically degrade image quality. Lowering tube current enhances image noise, which may negatively affect the quality of low-contrast tissue image. The density and spatial resolution of the 64-slice spiral CT are satisfactory. Following imaging, the morphology of the urinary tract can be visualized from multiple angles and dimensions, which effectively compensates for any deficiencies in LDCT imaging resolution. In this study, we demonstrated that CDCT and LDCT produced consistent stone detection rates.
This study had several limitations. First, while preliminary findings from the in vitro model guided the selection of 60 mAs. Although 100% detection accuracy was achieved at 60 mAs, the sample size was relatively limited. Higher tube loading settings, such as 80 mAs or 100 mAs, may improve detection accuracy, especially for stones with lower calcium content or in more complex pathological scenarios. It is important to note that, while LDCT was effective for detecting urinary calculi, its utility in diagnosing other causes of symptoms, such as low back pain or hematuria, may be limited. These symptoms can also arise from conditions like renal tumors, pyelonephritis, or diseases affecting other abdominal organs, including the liver, gallbladder, pancreas, and bowel. Therefore, LDCT should be used in conjunction with other diagnostic methods for a comprehensive evaluation and accurate diagnosis. Additionally, the initial scanning was performed with a slice thickness of 5 mm, which may result in signal averaging and obscure finer details. Although the images were later reconstructed to a slice thickness of 0.625 mm using the FBP method, partial volume effects could still affect the clarity of smaller structures. Furthermore, as per our study design, patients who tested positive on CDCT were subsequently tested with LDCT, leading to additional radiation exposure. Second, the ex vivo pork kidney model used in this study does not fully replicate the human abdominal environment, particularly in terms of tissue density and X-ray absorption. While we used human urinary calculi of various compositions, we focused on determining the optimal low dose for detecting stones of different compositions and sizes, rather than optimizing the dose specifically for each stone composition. Third, we did not assess the impact of CT number fluctuations caused by stone composition or noise effects. This is particularly important because low doses may miss stones with lower calcium content, which are more challenging to detect due to their lower CT values. Given these limitations, further research should focus on optimizing the dose for different stone compositions, expanding the sample size for more robust conclusions, and investigating the impact of CT number fluctuations and noise on stone detection. Additionally, future studies could consider using in vivo models that more accurately mimic human tissue properties to allow for a more comprehensive evaluation of LDCT’s clinical efficacy.
Conclusion
In conclusion, LDCT substantially reduces patient radiation exposure while maintaining acceptable image quality, demonstrating its significant potential for clinical application.
Notes
Funding
This work was supported by the Yancheng Medical Science and Technology Development Program project (No. YK2021065).
Conflict of Interest
No potential conflict of interest relevant to this article was reported.
Ethical Statement
The study was approved by the Research Ethics Committee of Binhai County People’s Hospital (No. 2023-BYKYLL-029), and all participating provided informed consent.
Data Availability
The data supporting the findings of this study are available from the corresponding author, Ke Zhu, upon reasonable request.
Author Contribution
Conceptualization: Zhu K. Formal analysis: Xie Y, Gu Y, Tao J, Liu H. Funding acquisition: Xie Y. Visualization: Xie Y, Gu Y, Tao J, Liu H. Writing - original draft: Xie Y, Gu Y. Writing - review & editing: all authors. Approval of final manuscript: all authors.
