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Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis

Descriptive Information
Brief Title † Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis
Official Title †
Brief Summary 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.
Detailed Description 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.
Study Phase N/A
Study Type † Observational
Study Design † N/A
Primary Outcome Measure †
Secondary Outcome Measure †
Condition † Multiple Sclerosis
Intervention † Drugstandard gadolinium contrast
Study Arms / Comparison Groups
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Drug
Estimated Enrollment † 100
Start Date † April 1999
Completion Date
Primary Completion Date
Eligibility Criteria † 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
Gender Both
Ages 20 Years - 70 Years
Accepts Healthy Volunteers Accepts Healthy Volunteers
Contacts †† Robert I. Grossman, MD, 212-263-3269
Location Countries † United States
Administrative Information
NCT ID † NCT00006060
Organization ID 199/15245
Secondary IDs †† UPSM-704-0, UPSM-070300, UPSM-NS-29029
Responsible Party
Study Sponsor † National Center for Research Resources (NCRR)
Collaborators †† University of Pennsylvania
Investigators † Study Chair: Robert I. Grossman, MD, New York University
Information Provided By
Verification Date March 2009
First Received Date † July 5, 2000
Last Updated Date March 10, 2009
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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