Clinical trial NCT00937157: Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
Official title: Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Keywords: Inflammation
Multiple Sclerosis
Glatiramer Acetate
Gd enhancing lesions
1.5T protocol
3T protocol
Magnetization transfer imaging (MTI)
Lesion activity analysis
Copaxone
Lead sponsor: University at Buffalo
Sponsor class: OTHER
Collaborators: name: Teva Neuroscience, Inc.
First posted: 2009-07-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study will:

* Explore whether GA decreases inflammation more on the 3T optimized protocol when compared to the 1.5T standard protocol.

  * Compare whether the decrease in the cumulative number of Gd-enhancing lesions significantly differs between pre-treatment (day 0) and post-treatment (12 months) using 1.5T standard and 3T optimized protocols.
* Investigate the correlation between MTR and the cumulative number and volume of Gd enhancing lesions on 1.5T standard and 3T optimized protocols in patients treated with GA.

This study suggests that GA may favorably affect early events in lesion formation, in addition to exerting more transient beneficial effects on established areas of inflammation and demyelination, and that this effect may be observed only with the 3T optimized protocol.

Detailed description: Interferon-β (IFN- β) and glatiramer acetate (GA) are the two main groups of drugs used in the treatment of multiple sclerosis (MS). Notably, while both ultimately decrease central nervous system (CNS) inflammation, they do so by very different mechanisms. Therefore, use of 1.5T MRI, triple dose of Gd, delay of scanning time for 20-30 min after Gd injection, and application of off-resonance saturated MT pulse may increase the ability to detect Gd lesions by approximately 120% when compared to 1.5T single dose MRI protocol. The 3T standard protocol may increase the ability to detect Gd enhancing lesions by 40-50% when compared to the 1.5T standard protocol. This may indicate that the 3T optimized protocol may increase the ability for Gd lesion detection by approximately 150-180%, when compared to the 1.5T standard protocol.

Eligibility criteria: Inclusion Criteria:

* Patients diagnosed with clinically definite MS according to the McDonald criteria
* Have a Gd enhancing lesion using 1.5T standard protocol and/or an acute relapse
* Age 18-65
* Have a relapsing-remitting (RR) disease course or clinically isolated syndrome (CIS) with high risk of conversion to clinically definite (CD) MS (presence of \>9 T2 lesions in addition to 1 Gd lesion)
* Have EDSS scores less than or equal to 5.5
* Have disease duration of 3 months to 30 years
* None of the exclusion criteria

Exclusion Criteria:

* Previous immunomodulatory or immunosuppressant treatment during the 30 days prior to day 0 of the study with the following agents (e.g., IFN-β, GA, mitoxantrone, cyclophosphamide, cladribine, fludarabine, cyclosporine, total body, azathioprine, methotrexate, IVIG, cellcept, natalizumab, etc.)

Primary outcomes:
measure: A Change in the Cumulative Number of Gd Enhancing Lesions Using a 3T Protocol.
timeFrame: Change from baseline at 180 days and change from baseline at 360 days
Secondary outcomes:
Other outcomes:
Locations:
city: Buffalo
country: United States
facility: Jacobs Neurological Institute
state: New York
Study officials:
affiliation: University at Buffalo
name: Robert Zivadinov, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: