Advanced MRI Sequences in Multiple Sclerosis and Its Mimics | NCT03608605

Studies
Advanced MRI Sequences in Multiple Sclerosis and Its Mimics

NCT03608605

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Aug 1, 2018Actual

Enrollment

70Estimated

Phase

Not provided

Conditions

Multiple Sclerosis

Interventions

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Estimated

Primary Completion Date

Apr 1, 2020Estimated

Completion Date

Jul 1, 2020Estimated

First Submitted Date

Jul 18, 2018

First Submission Date that Met QC Criteria

Jul 30, 2018

First Posted Date

Aug 1, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 30, 2018

Last Update Posted Date

Aug 1, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Samaa Mostafa El-kossi, assisstant lecturer, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Establishing the diagnosis of multiple sclerosis and differentiate it from its mimics.
Predict the prognosis and evaluate the treatment response in the first year of patients with multiple sclerosis.

Detailed 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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Device	magnetic resonance imaging with advanced sequences including tractography,volumetry and inversion recovery

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

All patients among those attend to Assiut university hospital with clinical symptoms suspicious of MS according to McDonald criteria 2017 with age range from (18-50 years old).

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
samaa el-kossi, master	Contact	01028820033		samaa.mostafa12330@gmail.com
gehan sayed, doctorate	Contact			gehanseif@yahoo.com

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009103	Multiple Sclerosis

Ancestor Terms

ID	Term
D020278	Demyelinating Autoimmune Diseases, CNS
D020274	Autoimmune Diseases of the Nervous System
D009422	Nervous System Diseases
D003711	Demyelinating Diseases

Browse Leaves

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Browse Branches

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