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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05093751
Other study ID # SNUH-MNG-AI001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 23, 2013
Est. completion date September 30, 2021

Study information

Verified date October 2021
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

U-Net-based architectures will be applied to 500 contrast-enhanced axial MR images of different patients from a single institution after manual segmentation of meningioma, of which 50 were used for testing. Tumor volumetry after autosegmentation by trained U-Net-based architecture is final goal.


Description:

U-Net-based architectures will be applied to 500 contrast-enhanced axial MR images of different patients from a single institution after manual segmentation of meningioma, of which 50 were used for testing. After preprocessing with Z-isotropification and intensity normalization of images, 3 U-Net-based networks (2D U-Net, Attention U-Net, 3D U-Net) and 3 nnU-Net-based networks (2D nnU-Net, Attention nnU-Net, 3D nnU-Net) will be trained with meningioma-segmented images. For applying to 3D networks, sagittal and coronal images will be reconstructed using axial images. After prediction, the cut-off of the probability function, which is a trade-off, will be obtained with the Gaussian Mixture Modeling algorithm using the probability density function. The voxels having a probability function higher than that will be finally predicted as meningioma. Tumor volume is calculated as the sum of the product of segmented area and thickness of axial images. For performance evaluation, dice similarity coefficient (DSC), precision, and recall will be evaluated compared with manually segmented voxels for validation datasets. The results of volumetry of each model will be compared with manual segmentation-based volume through Pearson's correlation analysis.


Recruitment information / eligibility

Status Completed
Enrollment 600
Est. completion date September 30, 2021
Est. primary completion date September 30, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Radiologically diagnosed meningioma by MRI Exclusion Criteria: - under 18 years old - Multiple meningiomas - Orbital meningioma - Any prior treatment for intracranial meningioma before registration

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Observation
This study does not involve any intervention to subjects.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Outcome

Type Measure Description Time frame Safety issue
Primary Accuracy compared with ground truth As a primary endpoint, we will examine the ability of U-Net and nnU-Net to segment meningioma in brain MR compared with ground truth. Ground truth is defined as area on MR drawn by two neurosurgeons. Accuracy of autosegmentation of meningioma will be assessed in dice similarity coefficient, recall, and precision. 10-01-2020 until 09-30-2021
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