View Clinical Trial (Medical Research Study)
Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis
| City: |
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New York |
| State: |
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New York |
| Zip Code: |
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10016 |
| Conditions: |
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Multiple Sclerosis |
| Purpose: |
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OBJECTIVES: I. Determine by quantitative magnetic resonance imaging measurements the change
in the total volume of brain parenchyma as well as its gray and white matter, T2 and
enhanced T1 lesion volume, and the magnetization transfer ratio histogram parameters, and
correlate these measurements with clinical measures of disability in patients with multiple
sclerosis.
II. Measure the quantity of whole brain N-acetylaspartate in patients with multiple
sclerosis and compare these values to those from age matched controls.
III. Determine the correlation between specific neuropsychological tests which assess
global cognitive functioning and the quantitative measurements taken in these patients in
this study.
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| Study Summary: |
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PROTOCOL OUTLINE:
Patients undergo magnetic resonance imaging and spectroscopy with standard gadolinium
contrast followed by neuropsychological testing every 6 months for 5 years. An equal number
of age and sex matched healthy patients act as a control group and undergo magnetic
resonance imaging and spectroscopy without standard gadolinium contrast every 6 months for 5
years.
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| Criteria: |
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PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
- Diagnosis of multiple sclerosis Relapsing-remitting defined as 2 exacerbations and a
worsening of neurologic function over 1 day followed by at least 30 days of no
progression OR Secondary-progressive defined as increase of at least 1.0 unit on
Expanded Disability Status Scale (EDSS) in past 2 years with or without exacerbations
--Prior/Concurrent Therapy--
- Biologic therapy: Prior interferon beta 1A, 1B, or glatiramer acetate No concurrent
interferon beta 1A, 1B, or glatiramer acetate
- Endocrine therapy: Concurrent oral and IV corticosteroids allowed
--Patient Characteristics--
- Performance status: EDSS no greater than 7.0
- Hematopoietic: No hematologic dysfunction including hemolytic anemia
- Hepatic: No hepatic dysfunction
- Renal: No renal dysfunction
- Cardiovascular: No cardiac pacemaker
- Other: Not pregnant or nursing Negative pregnancy test No intracranial clips, metal
implants, or external clips within 10 mm of head No metal in eyes No known gadolinium
texaphyrin allergy No known claustrophobia
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| NCT ID: |
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NCT00006060 |
| Primary Contact: |
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Study Chair
Robert I. Grossman, MD
New York University
Robert I. Grossman, MD
Phone: 212-263-3269
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| Backup Contact: |
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N/A |
| Location Contact: |
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New York, New York 10016
United States
Lois J. Mannon, BSRT, (MR) (R) CCRC
Phone: 212-263-3783
Email: lois.mannon@med.nyu.edu
Site Status: Recruiting |
| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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May 22, 2013 |
| Modifications to this listing: |
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