Multi-center Database Registry to Study Thalamus Changes Using AI in MS

Multiple Sclerosis Clinical Trial

Official title:

Creation of a Multi-center Database Registry to Study Real World Thalamus Volume Changes by Use of Artificial Intelligence in Patients With Multiple Sclerosis (MS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03920995
• Other study ID #: N/A-NI-MS-PI-13632
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: October 31, 2023

Study information

• Verified date: March 2024
• Source: University at Buffalo
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

In this study the Investigator's propose to validate a newly developed approach, DeepGRAI (Deep Gray Rating via Artificial Intelligence), to simplify the calculation of thalamic atrophy in a clinical routine and allow academic and community neurologists to plan, perform, and publish novel and influential clinical research using data from clinical routine, by employing deep machine learning (DML) pattern recognition (PR) information through use of artificial intelligence (AI).

Description:

This is a multicenter, observational, retrospective, cross-sectional and longitudinal population study of brain volume changes in MS patients. The retrospective electronic medical record (EMR) and brain MRI image data will be collected at participating MS centers and de-identified data will be integrated into a central research database. All the data to be integrated into the database has already been collected by physicians at the centers as part of their routine clinical practice and is thus non-interventional and retrospective in nature. This new approach will be compared to existing approaches of brain volume measurement that are currently widely available. This breakthrough approach would lead to potentially abandoning classis measurement of the specific brain volume structures and would be applicable in real-time in clinical routine.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

1. Patient diagnosed with relapsing-remitting (RR) MS

2. Access to raw MRI index scan images that meet all of the below criteria

1. MRI scan image acquired at index

2. The scan was performed on 1.5T or 3T scanners

3. The scan must have a T2-FLAIR sequence

3. Access to raw MRI post-index scan images that meet all of the below listed criteria

1. MRI scan image acquired at post-index

2. The scan was performed on 1.5T or 3T scanners

3. The scan must have a T2-FLAIR sequence

4. Age 18-85 at index

5. Fulfilling the MRI scan and clinical data requirements outlined in Table 2

6. None of the exclusion criteria

Exclusion Criteria:

1. Have received an investigational drug or experimental procedure during the study period

2. Women who were pregnant, or lactating at index or during the post-index period

3. Patients who had a relapse 30 days prior to the selected MRI scan date

4. Patients who received steroid treatment 30 days prior to the selected MRI scan date

5. Presence of other neurologic diseases affecting CNS

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United States	University at Buffalo	Buffalo	New York

Sponsors (2)

Lead Sponsor	Collaborator
University at Buffalo	Celgene

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multi-center registry of MRI scans	Measuring the ability of DeepGRAI to measure thalamus volume as a predictor of clinical outcomes for patients with multiple sclerosis	2 years