Advanced MRI Sequences in Multiple Sclerosis and Its Mimics

Multiple Sclerosis Clinical Trial

— MS  

Official title:

Role of Advanced MRI Sequences in Differentiating MS and Its Mimics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03608605
• Other study ID #: 17200227
• Status: Not yet recruiting
• Start date: September 1, 2018
• Est. completion date: July 1, 2020

Study information

• Verified date: July 2018
• Source: Assiut University
• Contact: samaa el-kossi, master
• Phone: 01028820033
• Email: samaa.mostafa12330[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

We aim to evaluate the role of conventional and advanced MRI sequences in:

1. Establishing the diagnosis of multiple sclerosis and differentiate it from its mimics.

2. Predict the prognosis and evaluate the treatment response in the first year of patients with multiple sclerosis.

Description:

All patients in the study will be referred among those attend to Assuit university hospital with clinical symptoms suspicious of MS according to McDonald criteria 2017 with age range from (18-50 years old).

MRI study will be done for each patient. MRI study will be repeated for those already diagnosed as MS after starting the suitable treatment as decided by attending physician after one year to assess the efficacy of treatment and the patient prognosis.

MR imaging will be performed on a 1.5-T MR imaging unit (Siemens, Sembra medical system,German).

Prospectively completed data forms will be analyzed and compared. Statistical tests appropriate to the nature of the data will be used.

All patients will not be subjected to risk of any kind during this study. All patients' data will be confidentially kept. Approval of the ethical committee of Faculty of Medicine, Assiut University.

An informed consent will be taken from all patients included in this study.

• The research will be conducted only by scientifically qualified and trained personnel.

• The procedures included in this study have been already used in hospital and centers in and outside Egypt.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: July 1, 2020
• Est. primary completion date: April 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• All patients in the study will be referred among those attend to Assuit university hospital with clinical symptoms suspicious of MS according to McDonald criteria 2017 with age range from (18-50 years old).

Exclusion Criteria:

• o Any general contraindication of MRI in some cases as presence of paramagnetic substance as pacemakers or in patients with claustrophobia.

• Patient above 50 years old.

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

Device:
• MRI
magnetic resonance imaging with advanced sequences including tractography,volumetry and inversion recovery

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	role of advanced MRI sequences in establishing the diagnosis of multiple sclerosis(MS)	calculating the sensitivity,specificity and accuracy of diffusion tensor imaging (DTI) and dual inversion recovery(DIR) in differentiating MS from its mimics	baseline
Secondary	follow up of MS patients after one year of treatment	assess the degree of brain atrophy after one year mainly in the white matter and cerebral cortex using 3DT1WI	one year