- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03893812
Color Doppler and Mri Diffusion in Major Salivary Gland Masses
March 26, 2019 updated by: Mohamed Ahmed Alam El-Din, Assiut University
Combined Role of Color Doppler and Diffusion Weighted MRI In Differentiation Between Benign and Malignant Tumors of Major Salivary Glands
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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)
Study Type
Observational
Enrollment (Anticipated)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mohamed AH Alam El-Din, Doctor
- Phone Number: 01093900515
- Email: mohamedalam03@gmail.com
Study Contact Backup
- Name: Radwa KA Abd El-Naser, MD
- Phone Number: 01009910070
- Email: radwa.soliman@yahoo.co.ek
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
Adult patients with a suspicious swelling in major salivary glands.
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The ADC values and Color Doppler values (PSV-PI-RI) of major salivary gland masses
Time Frame: baseline
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 1, 2019
Primary Completion (Anticipated)
October 1, 2019
Study Completion (Anticipated)
November 1, 2019
Study Registration Dates
First Submitted
March 26, 2019
First Submitted That Met QC Criteria
March 26, 2019
First Posted (Actual)
March 28, 2019
Study Record Updates
Last Update Posted (Actual)
March 28, 2019
Last Update Submitted That Met QC Criteria
March 26, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- doppler & MRdiffusion salivary
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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