Salivary Gland DiseasesNCT03893812
Color Doppler and Mri Diffusion in Major Salivary Gland Masses
An observational study of Salivary Gland Diseases, run by Assiut University.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Salivary Gland Diseases
- What is being tested?
- MRI and Ultrasound
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Oct 2019to Nov 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with a suspicious swelling in major salivary glands.
Who may be able to join
- 1- patients must be 18 of age or older. 2= patients must have a suspicious swelling in major salivary glands.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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)
- Conditions
- Salivary Gland Diseases
- Being tested
- MRI, Ultrasound
- Medical subject headings
- Salivary Gland Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
diffusion weighted MR
UltrasoundDevice
Color Doppler ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2019
- Study startOct 2019 (estimated)
- Primary completionOct 2019 (estimated)
- Study completionNov 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Salivary Gland DiseasesStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ahmed Alam El-Din, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03893812
- Sponsor's protocol ID
- doppler & MRdiffusion salivary
- Status last verified
- Mar 2019
- First submitted
- 26 Mar 2019
- Last updated
- 28 Mar 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Role of Color Doppler and Diffusion Weighted MRI In Differentiation Between Benign and Malignant Tumors of Major Salivary Glands
- ClinicalTrials.gov ID
- NCT03893812
- Acronym / sponsor ID
- doppler & MRdiffusion salivary
- Conditions
- Salivary Gland Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2019 (estimated)
- Primary completion
- Oct 2019 (estimated)
- Study completion
- Nov 2019 (estimated)
- First posted
- 28 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with a suspicious swelling in major salivary glands.
Key inclusion criteria (1 listed)
- 1- patients must be 18 of age or older. 2= patients must have a suspicious swelling in major salivary glands.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIdiffusion weighted MR | Device | – |
| UltrasoundColor Doppler ultrasound | Device | – |
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Salivary Gland Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed AH Alam El-Din, Doctor (01093900515, mohamedalam03@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The ADC values and Color Doppler values (PSV-PI-RI) of major salivary gland masses (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2019.