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Currently, you can access the following clinical trials being conducted worldwide:

359,057 studies
in
219 countries
Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.
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Drug Interventions

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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/25/2021.

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

Clinicaltrials.gov identifier NCT03920995

Recruitment Status Not yet recruiting

First Posted April 19, 2019

Last update posted April 22, 2019

Study Description

Brief 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).

  • Condition or Disease:Multiple Sclerosis
  • Intervention/Treatment:
  • Phase: N/A
Detailed 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.

Study Design
  • Study Type: Observational
  • Estimated Enrollment: 1000 participants
  • Observational Model: Case-Only
  • Time Perspective: Retrospective
  • 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)
  • Estimated Study Start Date: April 2019
  • Estimated Primary Completion Date: September 2020
  • Estimated Study Completion Date: March 2021
Outcome Measures
  • Primary Outcome Measures: 1. Multi-center registry of MRI scans [ Time Frame: 2 years ]
    Measuring the ability of DeepGRAI to measure thalamus volume as a predictor of clinical outcomes for patients with multiple sclerosis
Eligibility Criteria
  • Ages Eligible for Study: 18 to 85 Years (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No
  • Sampling Method: Non-Probability Sample
  • Study Population: Individuals with Multiple sclerosis who have 2 MRI scans
Criteria

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

Contacts and Locations
Contacts

Contact: Robert Zivadinov 716-859-7040 rzivadinov@bnac.net

Contact: Cheryl Kennedy 716-888-4847 ckennedy@bnac.net

Locations
Sponsors and Collaborators

University at Buffalo

Celgene

More Information
  • Responsible Party: University at Buffalo
  • ClinicalTrials.gov Identifier: NCT03920995 History of Changes
  • Other Study ID Numbers: N/A-NI-MS-PI-13632
  • First Posted: April 19, 2019 Key Record Dates
  • Last Update Posted: April 22, 2019
  • Last Verified: April 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Additional relevant MeSH terms: Multiple Sclerosis Sclerosis