New York, New York 10016


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

199/15245


NCT ID:

NCT00006060


Secondary ID:

UPSM-704-0


Study Acronym:


Brief Title:

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


Official Title:


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

20 Years


Maximum Age:

70 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Office of Rare Diseases (ORD)


Oversight Authority:

United States: Federal Government


Reasons Why Stopped:


Study Type:

Observational


Study Design:

N/A


Number of Arms:

0


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:


Overall Contact Information

Official Name:Robert I. Grossman, MD
Study Chair
New York University
Primary Contact:Robert I. Grossman, MD
212-263-3269

Study Dates

Start Date:April 1999
Verification Date:March 2009
Last Changed Date:March 10, 2009
First Received Date:July 5, 2000

Study Outcomes

There are no available Study Outcomes

Study Interventions

Intervention Type:Drug
Name:standard gadolinium contrast

Study Arms

There are no available Study Arms

Study Agencies

Agency Class:NIH
Agency Type:Lead Sponsor
Agency Name:National Center for Research Resources (NCRR)
Agency Class:Other
Agency Type:Collaborator
Agency Name:University of Pennsylvania

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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