Color Doppler and Mri Diffusion in Major Salivary Gland M... | NCT03893812

Studies
Color Doppler and Mri Diffusion in Major Salivary Gland Masses

NCT03893812

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Mar 28, 2019Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Salivary Gland Diseases

Interventions

MRI
Ultrasound

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

Mar 2019

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

Oct 2019Estimated

Primary Completion Date

Oct 2019Estimated

Completion Date

Nov 2019Estimated

First Submitted Date

Mar 26, 2019

First Submission Date that Met QC Criteria

Mar 26, 2019

First Posted Date

Mar 28, 2019Actual

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

Mar 26, 2019

Last Update Posted Date

Mar 28, 2019Actual

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

This study intend to evaluate the combined value of ADC and COLOR DOPPLER in differentiating benign and malignant salivary gland tumors in comparison to histopathological findings and its use in preoperative prediction of benign and malignant masses.

Detailed Description

the study aim to achieve preoperative differentiation between benign and malignant masses of the major salivary glands using the ADC values and Color Doppler values (PSV - PI - RI)

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

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
MRI	Device	diffusion weighted MR
Ultrasound	Device	Color Doppler ultrasound

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The ADC values and Color Doppler values (PSV-PI-RI) of major salivary gland masses	The ADC values and Color Doppler values (PSV-PI-RI) of major salivary gland masses will differ according to the nature of the mass determined by histopathological finding	baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

1- patients must be 18 of age or older. 2= patients must have a suspicious swelling in major salivary glands.

Exclusion Criteria:

Patients with history of metal plates or screws or artificial joints.
Patients who have phobia of indoor places.
Patients with contraindication to MRI like intra-cerebral aneurysmal clips, cardiac pacemaker, and metallic foreign body at region of examination.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult patients with a suspicious swelling in major salivary glands.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mohamed AH Alam El-Din, Doctor	Contact	01093900515		mohamedalam03@gmail.com
Radwa KA Abd El-Naser, MD	Contact	01009910070		radwa.soliman@yahoo.co.ek

Overall Officials

Not provided

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012466	Salivary Gland Diseases

Ancestor Terms

ID	Term
D009059	Mouth Diseases
D009057	Stomatognathic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D014463	Ultrasonography

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided