NCT03893812

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2019

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 26, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 28, 2019

Completed
6 months until next milestone

Study Start

First participant enrolled

October 1, 2019

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2019

Completed
Last Updated

March 28, 2019

Status Verified

March 1, 2019

Enrollment Period

Same day

First QC Date

March 26, 2019

Last Update Submit

March 26, 2019

Conditions

Salivary Gland Diseases

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

MRIDEVICE

diffusion weighted MR

UltrasoundDEVICE

Color Doppler ultrasound

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients with a suspicious swelling in major salivary glands.

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Salivary Gland Diseases

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Central Study Contacts

Mohamed AH Alam El-Din, Doctor

CONTACT

01093900515mohamedalam03@gmail.com

Radwa KA Abd El-Naser, MD

CONTACT

01009910070radwa.soliman@yahoo.co.ek

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 26, 2019

First Posted

March 28, 2019

Study Start

October 1, 2019

Primary Completion

October 1, 2019

Study Completion

November 1, 2019

Last Updated

March 28, 2019

Record last verified: 2019-03