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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03608605
Other study ID # 17200227
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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