Diagnostic Study of Quantitative Imaging and Spectroscopy... | NCT00006060

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

NCT00006060

Sponsor

National Center for Research Resources (NCRR)

Status

Unknown status

Last Update Posted

Mar 12, 2009Estimated

Enrollment

100

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

standard gadolinium contrast

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 1999

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jul 5, 2000

First Submission Date that Met QC Criteria

Jul 5, 2000

First Posted Date

Jul 6, 2000Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 10, 2009

Last Update Posted Date

Mar 12, 2009Estimated

Name	Class
University of Pennsylvania	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

No data available

No data is available for this block.

Biospecimen

No data available

No data is available for this block.

Enrollment

100

Name	Type	Description	Arm Group Labels	Other Names
standard gadolinium contrast	Drug

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Robert I. Grossman, MD	Contact	212-263-3269

Overall Officials

Name	Affiliation	Role
Robert I. Grossman, MD	New York University	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
New York University Medical Center	Recruiting	New York	New York	10016	United States

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis
D009461	Neurologic Manifestations
D001523	Mental Disorders
D035583	Rare Diseases

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

ID	Type	Description	Link
UPSM-704-0
UPSM-070300
UPSM-NS-29029