NCT03530098

Validation of an Artificial Intelligence-based Algorithm for Skeletal Age Assessment

Prospective, Multi-Center, Randomized Controlled Trial for Skeletal Age Assessment AI Model

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,903 (actual)
• Sponsor: Stanford University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to understand the effects of using an Artificial Intelligence algorithm for skeletal age estimation as a computer-aided diagnosis (CADx) system. In this prospective real-time study, the investigators will send de-identified hand radiographs to the Artificial Intelligence algorithm and surface the output of this algorithm to the radiologist, who will incorporate this information with their normal workflows to make an estimation of the bone age. All radiologists involved in the study will be trained to recognize the surfaced prediction to be the output of the Artificial Intelligence algorithm. The radiologists' diagnosis will be final and considered independent to the output of the algorithm.

Detailed description

The investigators are targeting to study the effect of their Artificial Intelligence algorithm on the radiologists' estimation of skeletal age. Currently, radiologists make the estimation using only the radiographic images and health records. As part of this study, the radiologists will estimate skeletal age from radiographic images, health records, and the output of the CADx algorithm. The investigators wish to understand how radiologists using the Artificial Intelligence algorithm compare to radiologists who do not for the specific task of estimating skeletal age. This study is organized as a multi-institutional randomized control trial with two arms - experiment (receiving the Artificial Intelligence algorithm's output) and control (no intervention). Both of these arms will be compared to a clinical reference standard ("gold standard") composed of a panel of radiologists. The metric of comparison will be Mean Absolute Distance (MAD). The investigators plan to use statistical tests such as the t-test to determine any statistically-significant difference in skeletal age estimation between the two groups. The investigators have recruited and analyzed data from a sample size of 1600 exams. Patients getting these exams will not undergo any research procedures that deviate from the current standard practices.

Conditions

• Bone Age

Interventions

Type	Name	Description
DEVICE	BoneAgeModel	BoneAgeModel is an Artificial Intelligence tool that takes in a hand radiograph and gender, and outputs the skeletal (bone) age. The intervention involves using this tool as a factor in the clinical decision making process of the participating radiologists. The radiologist's decision will be considered final.

Timeline

• Start date: 2018-07-12
• Primary completion: 2019-08-31
• Completion: 2019-08-31
• First posted: 2018-05-21
• Last updated: 2021-06-09
• Results posted: 2020-10-26

Locations

6 sites across 1 country: United States

Regulatory

• FDA-regulated device study