- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00006060
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.
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment
Contacts and Locations
Study Contact
- Name: Robert I. Grossman, MD
- Phone Number: 212-263-3269
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- Recruiting
- New York University Medical Center
-
Contact:
- Lois J. Mannon, BSRT, (MR) (R) CCRC
- Phone Number: 212-263-3783
- Email: lois.mannon@med.nyu.edu
-
Principal Investigator:
- Robert I. Grossman, MD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Collaborators and Investigators
Collaborators
Investigators
- Study Chair: Robert I. Grossman, MD, New York University
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 199/15245
- UPSM-704-0
- UPSM-070300
- UPSM-NS-29029
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multiple Sclerosis
-
University Hospital, Basel, SwitzerlandSwiss National Science FoundationRecruitingMultiple Sclerosis (MS) | Relapsing-remitting Multiple Sclerosis (RRMS) | Secondary-progressive Multiple Sclerosis (SPMS) | Primary Progressive Multiple Sclerosis (PPMS)Switzerland
-
University of California, Los AngelesUnknownRelapsing-remitting Multiple Sclerosis | Secondary-progressive Multiple Sclerosis | Primary-progressive Multiple SclerosisUnited States
-
BiogenCompletedMultiple Sclerosis | Relapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis, Remittent ProgressiveJapan
-
The Cleveland ClinicUniversity Hospitals Cleveland Medical CenterCompletedRelapsing-Remitting Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
-
University of California, San FranciscoUnited States Department of DefenseRecruitingMultiple Sclerosis, Chronic Progressive | Multiple Sclerosis, Relapsing-Remitting | Multiple Sclerosis (MS) | Multiple Sclerosis Relapse | Multiple Sclerosis, Primary Progressive | Multiple Sclerosis Brain Lesion | Multiple Sclerosis BenignUnited States
-
Icahn School of Medicine at Mount SinaiColumbia University; New York Stem Cell Foundation Research InstituteCompletedClinically Isolated Syndrome | Relapsing-Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
Rigshospitalet, DenmarkOdense University Hospital; Aarhus University Hospital; Hvidovre University Hospital and other collaboratorsRecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisDenmark
-
Queen Mary University of LondonTakeda Pharmaceuticals International, Inc.RecruitingRelapsing Remitting Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited Kingdom
-
Brigham and Women's HospitalMassachusetts General HospitalRecruitingMultiple Sclerosis | Relapsing Multiple Sclerosis | Primary Progressive Multiple Sclerosis | Secondary Progressive Multiple SclerosisUnited States
-
University of MinnesotaMallinckrodtTerminatedPrimary Progressive Multiple Sclerosis | Secondary Progressive Multiple Sclerosis | Progressive Relapsing Multiple SclerosisUnited States
Clinical Trials on standard gadolinium contrast
-
University of WashingtonCompletedContrast Media | Magnetic Resonance AngiographyUnited States
-
Imperial College LondonNational Institute for Health Research, United Kingdom; Imperial College Healthcare...WithdrawnMyocardial Fibrosis | Heart Failure | End Stage Renal Failure on Dialysis | Chronic Kidney Disease Stage V | Chronic Kidney Disease, Stage IV (Severe)United Kingdom
-
University Health Network, TorontoNot yet recruitingStroke | Neurovascular Disorder | Stenosis, CarotidCanada
-
NYU Langone HealthActive, not recruitingMyocardial InfarctionUnited States
-
Washington University School of MedicineSt. Louis Children's HospitalTerminated
-
Assistance Publique Hopitaux De MarseilleUnknownChronic Obstructive Pulmonary Disease (COPD)France
-
University of VirginiaUnknown
-
GE HealthcareCompletedMagnetic Resonance Imaging (MRI)Germany, Norway
-
University of California, Los AngelesNational Heart, Lung, and Blood Institute (NHLBI)WithdrawnHealthy | Heart Failure With Preserved Ejection FractionUnited States
-
NYU Langone HealthCompletedAlzheimer DiseaseUnited States