Elastography in the Evaluation of Major Salivary Gland Lesions

NCT05151029 | Unknown

• 1 other identifier: Major salivary gland lesions
• Study Type: observational
• Target: 34
• Locations: 0 countries
• Sites: N/A

Brief Summary

2.2 Aim(s) of the Research (50 words max): To investigate the diagnostic accuracy of Sonoelastography in the evaluation of major salivary gland lesions using histopathology as gold standard.

Conditions

Salivary Gland Diseases

Outcome Measures

Primary Outcomes (2)

• the diagnostic accuracy of Sonoelastography in the evaluation of major salivary gland lesions 2-The discrimination between different salivary gland diseases by non invasive available technique as far as possible. To investigate the dia

  Use of elastography in major salivarygland lesions benign or malignant

  from october 2022 to october 2023

• -The discrimination between different salivary gland diseases by non invasive available technique . -The discrimination between different salivary gland diseases by non invasive available technique as far as possible. -The discri

  Differentiation between salivary gland lesions

  from october 2022 to october 2023

Secondary Outcomes (1)

• Elastography importance in salivary gland disease

  From October 2022 to October 2023

Interventions

Elastography DEVICE

new dignostic tool

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients will be scanned in the supine position during free-breathing, with subtle neck hyperextension and tilt to the opposite side of the evaluation. The parotid and submandibular glands will be carefully examined in the transverse and longitudinal dimensions with an 8-12 MHz linear array transducer. Doppler assessment will then be done Subsequently, sonoelastography will be performed with the same depth and focus and gained settings as for grey scale imaging. First, strain elastography will be performed. The elastogram image of the detected lesion, will be evaluated using color coding . stiffness compared to normal parenchyma using a 4-grade system like the performed. Strain ratio values of all the lesiongrading presented by Dumitriu D et al. Second, shear wave elastography will be ps ,will also be calculated individually. All will be compared with histopathology results.

You may qualify if:

• All patients with clinically suspected lesions of parotid or submandibular glands .
• An equal number of healthy volunteers will be included during the same period as control group .

You may not qualify if:

• A mass with ulcerated or raw surface, involvement of the whole gland by the lesion or previous surgical treatment

Sponsors & Collaborators

• Assiut University: lead

Related Publications (3)

• Dumitriu D, Dudea S, Botar-Jid C, Baciut M, Baciut G. Real-time sonoelastography of major salivary gland tumors. AJR Am J Roentgenol. 2011 Nov;197(5):W924-30. doi: 10.2214/AJR.11.6529.

  PMID: 22021543 BACKGROUND

• Zhou H, Zhou XL, Xu HX, He YP, Bo XW, Li XL, Liu BJ, Li DD, Wang D. Initial Experience With Ultrasound Elastography for Diagnosis of Major Salivary Gland Lesions. J Ultrasound Med. 2016 Dec;35(12):2597-2606. doi: 10.7863/ultra.15.11093. Epub 2016 Oct 25.

  PMID: 27872416 BACKGROUND

• Karaman CZ, Basak S, Polat YD, Unsal A, Taskin F, Kaya E, Gunel C. The Role of Real-Time Elastography in the Differential Diagnosis of Salivary Gland Tumors. J Ultrasound Med. 2019 Jul;38(7):1677-1683. doi: 10.1002/jum.14851. Epub 2018 Nov 13.

  PMID: 30426518 BACKGROUND

MeSH Terms

Conditions

Salivary Gland Diseases

Interventions

Elasticity Imaging Techniques

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Samy abdelaziz

  professor of dignostic radiology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ramy refaat, master

CONTACT

01008608677; ramyrefaatayoub@outlook.com

Noha Attya

CONTACT

01065742341; Nohamohamedali@yahoo.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: November 5, 2021
• First Posted: December 9, 2021
• Study Start: September 1, 2022
• Primary Completion: September 1, 2023
• Study Completion: October 1, 2023
• Last Updated: December 9, 2021

Record last verified: 2021-11