Assessment of Mediastinal Masses With Diffusion Weighted... | NCT03214341

Studies
Assessment of Mediastinal Masses With Diffusion Weighted MR Imaging

NCT03214341

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Jul 11, 2017Actual

Enrollment

24Estimated

Phase

Not provided

Conditions

Mediastinal Tumor

Interventions

MRI diffusion

Countries

Egypt

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 2017

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

Dec 1, 2017Estimated

Primary Completion Date

Dec 1, 2019Estimated

Completion Date

Dec 30, 2019Estimated

First Submitted Date

Jun 24, 2017

First Submission Date that Met QC Criteria

Jul 10, 2017

First Posted Date

Jul 11, 2017Actual

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 10, 2017

Last Update Posted Date

Jul 11, 2017Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Gehad Mohammed Safwat Ali, Principal Investigator, Assiut UniversityPrincipal Investigator

Lead Sponsor

Assiut UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy which is essential for treatment planning as well as for prognosis

Detailed Description

Differentiation between benign and malignant mediastinal tumors as well as characterization and grading of malignancy is essential for treatment planning as well as for prognosis .

MRI presents valuable diagnostic information in assessing the mediastinum. In addition, special applications have been developed over recent years diffusion-weighted magnetic resonance imaging is one such technique The advent of echo-planar imaging technique has rendered diffusion weighted imaging of the abdomen and thoracic cavity possible .

Quantitative assessment of the mediastinal mass is possible by calculation of apparent diffusion co-efficient value ,which is related to the proportion of extracellular and intracellular component.

The apparent diffusion co-efficient is inversely correlated with tissue cellularity. It is lower in viable tumor tissue with densely packed diffusion-hindering obstacles than in tissue with less densely packed obstacles such as tumor necrosis and benign tissue .

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

24Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI diffusion	Radiation	using MRI diffusion to differentiate between benign and malignant mediastinal masses

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sensitivity and specificity of magnetic resonance imaging diffusion in mediastinal masses		up to one month

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Any age groups
diagnosis of mediastinal mass (by Multislice Computed Tomography).

Exclusion Criteria:

chemotherapy radiotherapy.
thoracic surgery.
cystic mass .
mass with large amount of necrosis or calcification.
contraindication of MRI (e.g. pacemakers , claustrophobia).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients with mediastinal masses

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Noha Mohammed Ali Attia, lecturer	Contact	00201001238435		nohamohammedali@yahoo.com
Mostafa Thabet Hussein, professor	Contact	00201122999878		Thabet.mostafa@yahoo.com

Overall Officials

Name	Affiliation	Role
Mostafa Thabet Hussein, professor	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university		Asyut			Egypt

References Module

Citations

Not provided

ID	Term
D013899	Thoracic Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D008477	Mediastinal Diseases

ID	Term
D059906	Neuroimaging
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis