Comparison of 1.5T vs. 3T Protocols After Treatment With Glatiramer Acetate (GA)
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Comparison of Standard 1.5 Versus 3T Optimized Protocols in Patients Treated With Glatiramer Acetate. A Conventional and Non-conventional MRI Study|
- A decrease in the cumulative number of Gd enhancing lesions using a 3T protocol. [ Time Frame: day 0, 3, 6, 9, & 12 months ] [ Designated as safety issue: No ]
- To determine the correlation of MTI and cumulative Gd enhancing lesions using the 1.5T and 3T protocols. [ Time Frame: day 0, 3, 6, 9 & 12 months ] [ Designated as safety issue: No ]
|Study Start Date:||September 2007|
|Study Completion Date:||April 2011|
|Primary Completion Date:||July 2010 (Final data collection date for primary outcome measure)|
Patients diagnosed with multiple sclerosis who have the presence of at least 1 or more Gd enhancing lesions and/or acute relapse.
12 MS patients will be enrolled on GA (Copaxone®) monotherapy (20mg/day sc). Initial intravenous steroid treatment will be given on day 0. 1.5T and 3T scans will be obtained and according to the following schedule: 1 gm Solumedrol i.v. daily for three days. Intravenous steroids will be also allowed for treatment of MS attacks according to the following schedule: 1 gm Solumedrol i.v. daily for three days.
Other Name: Glatiramer acetate
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00937157
|United States, New York|
|Jacobs Neurological Institute|
|Buffalo, New York, United States, 14203|
|Principal Investigator:||Robert Zivadinov, MD, PhD||University at Buffalo|