Characterisation of multiple sclerosis pathology by ultra small particles of iron oxide (USPIO)” in comparison with conventional and advanced MRI imaging techniques[Charakterisierung der Multiple Sklerose Pathologie durch ultra small particles of iron oxide (USPIO)” im Vergleich zu konventionellen und fortgeschrittenen MRT Techniken] - MS_USPIO_MPIP

Conditions: Patients with Multiple Sclerosis (MS, N=90) and patients with a clinically isolated syndrome (ref. to as CIS in literature, i. e. not a clinically definite MS but a syndrome that may occur as first sign of MS early in the course, N=15) are planned to be investigated in the proposed clinical trial.
MedDRA version: 8.1Level: LLTClassification code 10028245Term: Multiple sclerosis

Registration Number: EUCTR2006-001337-17-DE

Lead Sponsor: Max-Planck-Institute of Psychiatry

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

a. clinically definite MS acc. to McDonald's criteria for the MS group (N=90)
b. clinically isolated syndrome compatible with MS, no definite diagnosis of MS (for CIS patients, N=15)
b. age over or equal 18 years
d. cognitive abilities to give informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

a. Age below 18 years
b. Pregnancy
c. Withdrawal of consent
d. hypersensitivity to dextrane

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To define magnetic resonance imaging enhancement patterns in patients with multiple sclerosis (MS) and clinically isolated syndrome (CIS). Subgroups of patients with and without gadolinium enhancement and patients with and without immunomodulatory therapy are compared.;Secondary Objective: To quantifiy the enhancement strength and spatial pattern and compare it to gadolinium enhancement, lesion load, atrophy status, diffusion imaging and the clinical history, status and clinical disease progression data, respectively.;Primary end point(s): 1. USPIO enhancement pattern in cerebral and cervical MRI<br>2. Detailed clinical neurological status (EDDS score, MSFC score)

Secondary Outcome Measures