Elastography in the Evaluation of Major Salivary Gland Lesions

Salivary Gland Diseases Clinical Trial

Official title:

The Role of Real Time Elastography in the Evaluation of Major Salivary Gland Lesions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05151029
• Other study ID #: Major salivary gland lesions
• Status: Not yet recruiting
• Start date: September 1, 2022
• Est. completion date: October 1, 2023

Study information

• Verified date: November 2021
• Source: Assiut University
• Contact: Ramy refaat, master
• Phone: 01008608677
• Email: ramyrefaatayoub[@]outlook.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Salivary gland diseases are ranging from the minor inflammatory conditions to a group of benign and malignant neoplasms. Most of the salivary gland disorders manifest themselves as the enlargement of the gland which may be associated with pain or swelling. Physical examination together with laboratory analyses may not be sufficient to discriminate these diseases . Therefore, an accurate, non invasive diagnostic method is needed to discriminate these diseases (1). Although ultrasound-guided fine-needle aspiration cytology (FNAC) is considered the gold standard for preoperative diagnosis (2), it is an invasive method requiring significant experience to avoid complications like injury of the facial nerve as it courses within the parotid gland. This explains the continuing desire for further non-invasive diagnostic options (3). The current imaging modalities are ultrasonography, Computed Tomography (CT) and Magnetic Resonance Imaging (MRI). Despite being highly sensitive, they lack the accuracy in differentiating benign and malignant lesions because of considerable overlap between the imaging features of benign and malignant salivary gland lesions. Sonoelastography is a new technique that depends on the elastic properties of soft tissues, with the idea of malignant lesions being stiffer than benign or normal tissue. It may have a dependable role in diagnosing different salivary gland diseases, the same way it has been used in different parts of the body, such as the breast, lymph nodes, and thyroid (4). To the best of our knowledge, there are few studies concerning the role of elastography in the field of salivary gland disease.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 34
• Est. completion date: October 1, 2023
• Est. primary completion date: September 1, 2023
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria

• 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 .

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Salivary Gland Diseases

Intervention

Device:
• Elastography
new dignostic tool

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & 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. — View Citation

Karaman CZ, Basak S, Polat YD, Ünsal A, Taskin F, Kaya E, Günel 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. — View Citation

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. Epub 2016 Oct 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	-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	Elastography importance in salivary gland disease	Differentiation of Salivary gland masses	From October 2022 to October 2023