Validation of AI Lumbar Spine Anatomy Measureing Function

Completed

• Conditions: Spinal Cord Compression

• Registration Number: NCT06950411
• Lead Sponsor: RadiRad Co., Ltd.

Brief Summary

Spinal degeneration and its associated clinical diseases are common ailments in aging societies. With the advent of a super-aging society, the importance of assistive technologies for spinal image interpretation is increasingly significant to enhance care efficiency and reduce medical personnel expenditure. Recently, due to the rapid development of artificial intelligence (AI) algorithm, AI-based computer-assisted detection (CADe) devices gradiually become a convenient method for spinal anatomy measurement. However, the accuracy of these devices has not been fully established. This study aims to validate the performance of RadiSpine (an application program) in spinal anatomy segmentation and measurement.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-12
• Primary Completion: 2025-03-31
• Study Completion: 2025-03-31
• Status Verified: 2025-04
• Study First Submitted: 2025-04-10
• Study First Submitted QC: 2025-04-24
• Last Update Submitted: 2025-04-24
• Study First Posted: 2025-04-30
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

The subjects should be aged 20 or older and younger than 75, with an equal gender distribution of 50% male and 50% female. From this group, 150 subjects with reasonable datavalues will be selected, with a requirement that at least 30% of them are male and at least 30% are female.

Exclusion Criteria

1. With history of spinal surgery
2. Spinal trauma
3. Spinal osteoporosis
4. Spinal metastasis or infection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Segmentation accuracy (Mean)	30 mins per individual	The minimum Mean Dice Coefficient (MDC), defined as the lower limit of the 95% confidence interval (CI) for MDC, is above a predetermined allowable limit equal to 0.8

Secondary Outcome Measures

Name	Time	Method
Measurement accuracy	30 mins per individual	The maximum Mean Absolute Error (MAE), defined as the upper limit of the 95% CI for MAE, is below a predetermined allowable error limit equal to 2 mm

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei, Taiwan