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Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis
This study is currently recruiting participants.
Study NCT00006060   Information provided by Office of Rare Diseases (ORD)
First Received: July 5, 2000   Last Updated: March 10, 2009   History of Changes

July 5, 2000
March 10, 2009
April 1999
 
 
 
Complete list of historical versions of study NCT00006060 on ClinicalTrials.gov Archive Site
 
 
 
Diagnostic Study of Quantitative Imaging and Spectroscopy in Patients With Multiple Sclerosis
 

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.

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.

 
Observational
 
Multiple Sclerosis
Drug: standard gadolinium contrast
 
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
Recruiting
100
 
 

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
Both
20 Years to 70 Years
Yes
Contact: Robert I. Grossman, MD 212-263-3269
United States
 
NCT00006060
 
199/15245, UPSM-704-0, UPSM-070300, UPSM-NS-29029
National Center for Research Resources (NCRR)
University of Pennsylvania
Study Chair: Robert I. Grossman, MD New York University
Office of Rare Diseases (ORD)
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP