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| ID | Type | Description | Link |
|---|---|---|---|
| 660399 | Other Identifier | Regional Committees for Medical Research Ethics (in Norway) |
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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.
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:
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):
Image data:
Clinical radiology report:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adults investigated with CT for suspected urinary stone disease | Newly occurring colic pain and clinical suspicion of kidney stones or known kidney stone with new/increasing symptoms. Age ≥ 18 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Comparison of stone diameter from manual segmentation with radiology report | Stone diameter (in mm) compared between manual segmentation and radiology report (paired t-test or wilcoxon rank sum test if non-normally distributed data) | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Comparison of AI-segmentation of stones (DICE-score) with manual segmentation | DICE-score for AI-segmentation of stones, compared to manual segmenation (gold standard) | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Prospective performance (diagnostic accuracy) of AI detection of ureteral stone (compared to radiology report (gold standard) | Comparison of differences in dicotomous proportions in paired data according to Newcombe | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of stone density from manual segmentation with radiology report | Stone density (in Hounsfield Units) compared between manual segmentation and radiology report (paired t-test or wilcoxon rank sum test if non-normally distributed data) | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients referred for CT for new/acute episode of renal colic and suspicion of /or known urinary stone disease.
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| Name | Affiliation | Role |
|---|---|---|
| Peter M. Lauritzen, MD, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital, Aker | Oslo | 0586 | Norway |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 30, 2024 | May 8, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014545 | Urinary Calculi |
| D056844 | Renal Colic |
| D014517 | Ureteral Obstruction |
| D052878 | Urolithiasis |
| D053039 | Ureterolithiasis |
| D007669 | Kidney Calculi |
| ID | Term |
|---|---|
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| Comparison of distention of renal pelvis from manual segmentation with radiology report |
Distention of renal pelvis (in mm) compared between manual segmentation and radiology report (paired t-test or wilcoxon rank sum test if non-normally distributed data) |
| At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Comparison of AI-segmentation of stones (Hausdorff distance) with manual segmentation | Haussdorff distance for AI-segmentation of stones, compared to manual segmenation (gold standard) | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Comparison of AI-segmentation of stones (diagnostic accuracy) with manual segmentation | Diagnostic accuracy for AI-segmentation of stones compared to manual segmenation (gold standard) | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Comparison of AI-segmentation of renal pelvis (Dice-score) with manual segmentation | DICE-score for AI-segmentation of renal pelvis compared to manual segmenation (gold standard) | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Comparison of AI-segmentation of renal pelvis (Hausdorff distance) with manual segmentation | Hausdorff distance for AI-segmentation of renal pelvis compared to manual segmenation (gold standard) | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Comparison of AI-segmentation of renal pelvis (diagnostic accuracy) with manual segmentation | Diagnostic accuracy for AI-segmentation of renal pelvis compared to manual segmenation (gold standard) | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Comparison of AI-segmentation of renal parenchyma (DICE-score) with manual segmentation | DICE-score for AI-segmentation of renal parenchyma compared to manual segmenation (gold standard) | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Comparison of AI-segmentation of renal parenchyma (Hausdorff distance) with manual segmentation | Hausdorff distance for AI-segmentation of renal parenchyma compared to manual segmenation (gold standard) | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Comparison of AI-segmentation of renal parenchyma (diagnostic accuracy) with manual segmentation | Diagnostic accuracy for AI-segmentation of renal parenchyma compared to manual segmenation (gold standard) | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| Prospective performance (diagnostic accuracy) of AI detection of ureteral obstruction (compared to radiology report (gold standard) | Comparison of differences in dicotomous proportions in paired data according to Newcombe | At time of CT examination (inclusion and follow up - expected average 12 weeks) |
| D052801 | Male Urogenital Diseases |
| D002137 | Calculi |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D014515 | Ureteral Diseases |
| D053040 | Nephrolithiasis |
| D007674 | Kidney Diseases |