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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00006060
Enrollment
100
Registered
2000-07-06
Start date
1999-04-30
Completion date
Unknown
Last updated
2009-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, neurologic and psychiatric disorders, rare disease

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.

Interventions

DRUGstandard gadolinium contrast

Sponsors

University of Pennsylvania
CollaboratorOTHER
National Center for Research Resources (NCRR)
Lead SponsorNIH

Eligibility

Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes

Inclusion 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

Countries

United States

Contacts

Primary ContactRobert I. Grossman, MD
212-263-3269

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026