Clinical Trials Logo

Clinical Trial Summary

Kidney stone disease causes significant morbidity, and stones obstructing the ureter can have serious consequences. Imaging diagnostics with computed tomography (CT) are crucial for diagnosis, treatment selection, and follow-up. Segmentation of CT images can provide objective data on stone burden and signs of obstruction. Artificial intelligence (AI) can automate such segmentation but can also be used for the diagnosis of stone disease and obstruction. In this project, the aim is to investigate if: Manual segmentation of CT scans can provide more accurate information about kidney stone disease compared to conventional interpretation. AI segmentation yields valid results compared to manual segmentation. AI can detect ureteral stones and obstruction or predict spontaneous passage.


Clinical Trial Description

Background: Goals and Objectives: The project aims to contribute to personalized and improved treatment and follow-up of patients with kidney stones using radiomics and the development of an artificial intelligence tool for CT examination assessment. The objectives are to assess: - Whether manual segmentation of CT images of the urinary tract provides equivalent or more accurate information about kidney stone disease compared to conventional interpretation and reporting. - Whether segmentation performed with AI yields valid results compared to manual segmentation. - Whether AI can detect ureteral stones and obstruction and/or predict spontaneous passage of stones. Method: Cohort: Patients are recruited to the study at Oslo University Hospital, Radiology Department, Section Aker, which performs approximately 1350 CT examinations for urinary tract stones in approximately 1000 patients each year. Approximately 500 patients with a new episode or newly occurring colic pain and clinical suspicion of kidney stones are expected to be included. Clinical data (where available): - Baseline CT: date and image data - Initial treatment (conservative, URS, PCN, ESWL) decision after baseline CT - Follow-up CT: date and image data - Time to spontaneous stone passage (negative control CT) or completed surgical intervention (URS) - Any other surgical/invasive procedure - Stone chemical analysis - Clinical biochemistry: creatinine/eGFR, CRP, leukocytes (at baseline and follow-ups). Image data: Clinical radiology report: - Stone: (largest calculus and any obstructing calculus): largest diameter in any plane, density (ROI set by clinical judgment, largest possible ROI - in the slice where the stone is largest), location (upper ureter: above crossing of vessels, lower ureter: below crossing of vessels, ostial: in bladder wall) - Renal pelvis: largest diameter of calyx neck lower calyx, clinical assessment of dilation (not dilated/slight/moderate/severe). - Segmentation: - Stone: total segmented stone volume, largest diameter, and density of segmented stone. - Collecting system: total segmented volume of the collecting system and renal pelvis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06412900
Study type Observational [Patient Registry]
Source Oslo University Hospital
Contact Peter M. Lauritzen, MD, PhD
Phone +4795248249
Email petlau@ous-hf.no
Status Not yet recruiting
Phase
Start date May 15, 2024
Completion date March 28, 2028

See also
  Status Clinical Trial Phase
Enrolling by invitation NCT04746378 - PRedictive Accuracy of Initial Stone Burden Evaluation.
Recruiting NCT05100017 - Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure N/A
Recruiting NCT04021381 - Citrate Salts for Stone-free Result After Flexible Ureterorenoscopy for Inferior Calyx Calculi Phase 3
Completed NCT02266381 - A Prospective Comparison of Fluoroscopic, Sonographic or Combined Approach for Renal Access in Percutaneous Nephrolithotomy N/A
Completed NCT01451931 - Study of Tomography of Nephrolithiasis Evaluation Phase 4
Terminated NCT01431378 - Pilot Study of Model Based Iterative Reconstruction Using 64-Slice N/A
Completed NCT02895711 - Radiation Dose of Pediatric Patients During Ureteroscopy
Completed NCT01295879 - Vitamin D Repletion in Stone Formers With Hypercalciuria Phase 4
Completed NCT05340075 - Staged Bilateral Percutaneous Nephrolithotomy
Recruiting NCT03919227 - Measurement of Resistance During UAS Insertion Procedure in RIRS N/A
Recruiting NCT03717285 - Under Direct Vision vs Under Non Direct Vision of Insertion of UAS in RIRS N/A
Completed NCT05340088 - Optimal Passive Dilation Time in Retrograde Intrarenal Surgery
Completed NCT05032287 - Medical Expulsive Therapy Post-SWL For Renal Stones N/A
Recruiting NCT05701098 - SOUND Pivotal Trial - (Sonomotion stOne comminUtion resoNance ultrasounD) N/A
Not yet recruiting NCT04080973 - Metabolic Workup in Patients Suffering From Kidney Stone Disease and Osteopenia N/A
Terminated NCT01736358 - The Use of Intranasal Ketoralac for Pain Management (Sprix) Phase 4
Completed NCT01792765 - Management of Ureteral Calculi Using Ultrasound Guidance: A Radiation Free Approach N/A
Completed NCT06211842 - Genetic Variations That Increase the Risk for Calcium Kidney Stones: a Family-based Study
Not yet recruiting NCT02214836 - Ultrasound Imaging of Kidney Stones and Lithotripsy N/A
Not yet recruiting NCT04606758 - Fluoroscopic Guided vs US-guided Percutaneous Nephrolithotripsy for the Treatment of Stone Disease N/A