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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2006-001337-17-DE
Enrollment
Unknown
Registered
2007-03-26
Start date
2007-09-25
Completion date
Unknown
Last updated
2012-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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: 8.1 Level: LLT Classification code 10028245 Term: Multiple sclerosis

Interventions

Product Name: ultra small particles of iron oxide (USPIO) Product Code: "SH U 555 C" Pharmaceutical Form: Solution for infusion INN or Proposed INN: "SH U 555 C" CAS Number: V08CB03 Current Sponsor co

Sponsors

Max-Planck-Institute of Psychiatry
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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 2. Detailed clinical neurological status (EDDS score, MSFC score)—

Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026