Apply Machine Learning to the Interpretation of Urinary Crystal Morphology.

Kidney Calculi Clinical Trial

Official title:

Apply Machine Learning to the Interpretation of Urinary Crystal Morphology.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06178575
• Other study ID #: 112183-E
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: Far Eastern Memorial Hospital
• Contact: Yi-Shiou Tseng
• Phone: 0920376341
• Email: tysgroupone[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to developing an image-based artificial intelligence software that can automatically interpret the types and sizes of crystals in urine. The main question[s] it aims to answer are:

• Allowing healthcare professionals to input urine images and receive real-time reading results on crystal types and sizes.

• This aims to provide a faster, more objective, and accurate analysis of crystals.

We anticipate delivering an image AI software suitable for practical applications, promoting the automation and accuracy of urine crystal analysis.

Description:

Kidney stones are primarily formed due to the supersaturation of ions in urine, leading to the formation of crystals. An assessment of the risk of kidney stones is based on a patient's medical history, biochemical urine tests, and various laboratory examinations. Combining these with imaging studies such as CT scans, ultrasound, and X-rays helps in diagnosing the type of kidney stones, though imaging results for smaller stones may be less accurate. Stone formation is common with a high recurrence rate, and there is a strong correlation between urine crystals and stone composition. Therefore, the analysis of urine crystals is meaningful for the diagnosis, evaluation of treatment strategies, and prevention of stone recurrence in kidney stone disease.

Microscopic analysis of urine crystals allows the observation of smaller crystals. However, manual urine microscopy is slow and time-consuming. To address this, we aim to develop artificial intelligence software to assist in the interpretation of urine crystals, providing a faster analysis. We will retrospectively analyze urine crystal images stored from previous research (Chang Gung Memorial Hospital Internal Project Research No. 107123-E) to identify crystal types. Subsequent image preprocessing and category labeling will be done to train and infer machine software. The results will be compared with manual interpretation to establish the accuracy of the software.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

• Retrospectively analyze the urine crystal images preserved from the previous study 107123-E for crystal type analysis. Subsequently, conduct image preprocessing and label categorization for machine software learning and inference. The interpreted results will then be assessed for accuracy using statistical analysis software.

Exclusion Criteria:

• Not applicable

Related Conditions & MeSH terms

• Calculi
• Kidney Calculi
• Nephrolithiasis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Yi-Shiou Tseng

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Kappa statistics	Used for comparing between a new instrument and a standard instrument to determine whether the new instrument exhibits a certain level of performance or accuracy.	The machine requires approximately 0.5 hours to complete the interpretation of around 800 urine crystal images.