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

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Primary Purpose

Status

Unknown status

Phase

Locations

United States

Study Type

Observational

Intervention

standard gadolinium contrast

About this trial

This is an observational trial for Multiple Sclerosis focused on measuring multiple sclerosis, neurologic and psychiatric disorders, rare disease

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

New York University Medical CenterRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00006060

First Posted

July 5, 2000

Last Updated

March 10, 2009

Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Pennsylvania

1. Study Identification

Unique Protocol Identification Number

NCT00006060

Brief Title

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

Study Type

Observational

2. Study Status

Record Verification Date

March 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 1999 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor

National Center for Research Resources (NCRR)

Collaborators

University of Pennsylvania

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Multiple Sclerosis

Keywords

multiple sclerosis, neurologic and psychiatric disorders, rare disease

7. Study Design

Enrollment

100 (false)

8. Arms, Groups, and Interventions

Intervention Type

Drug

Intervention Name(s)

standard gadolinium contrast

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Robert I. Grossman, MD

Phone

212-263-3269

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Robert I. Grossman, MD

Organizational Affiliation

New York University

Official's Role

Study Chair

Facility Information:

Facility Name

New York University Medical Center

City

New York

State/Province

New York

ZIP/Postal Code

10016

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Lois J. Mannon, BSRT, (MR) (R) CCRC

Phone

212-263-3783

Email

lois.mannon@med.nyu.edu

First Name & Middle Initial & Last Name & Degree

Robert I. Grossman, MD

Multiple Sclerosis

About this trial

Eligibility Criteria

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial