NCT05093751

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Longer than P75 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 23, 2013

Completed
8.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2021

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 1, 2021

Completed
25 days until next milestone

First Posted

Study publicly available on registry

October 26, 2021

Completed
Last Updated

October 26, 2021

Status Verified

October 1, 2021

Enrollment Period

8.5 years

First QC Date

October 1, 2021

Last Update Submit

October 13, 2021

Conditions

Keywords

MeningiomaArtificial intelligenceautosegmentationvolumetry

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Meningioma patients

Other: Observation

Interventions

This study does not involve any intervention to subjects.

Meningioma patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intracranial meningioma patients who were diagnosed by MRI are study population of this study. Inclusion in this study have not been decided according to whether or not surgery for tumor resection was performed or MRI thickness and magnetic power.

You may qualify if:

  • Radiologically diagnosed meningioma by MRI

You may not qualify if:

  • under 18 years old
  • Multiple meningiomas
  • Orbital meningioma
  • Any prior treatment for intracranial meningioma before registration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Meningioma

Interventions

Observation

Condition Hierarchy (Ancestors)

Neoplasms, Nerve TissueNeoplasms by Histologic TypeNeoplasmsNeoplasms, Vascular TissueMeningeal NeoplasmsCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNervous System Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

October 1, 2021

First Posted

October 26, 2021

Study Start

March 23, 2013

Primary Completion

September 30, 2021

Study Completion

September 30, 2021

Last Updated

October 26, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

We have no plan to share IPD