Clinical trial NCT05151029: Elastography in the Evaluation of Major Salivary Gland Lesions
Official title: The Role of Real Time Elastography in the Evaluation of Major Salivary Gland Lesions
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Salivary Gland Diseases
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-12-09
Enrollment: 34
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: from october 2022 to october 2023
measure: -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
timeFrame: from october 2022 to october 2023
Secondary outcomes:
measure: Elastography importance in salivary gland disease
timeFrame: From October 2022 to October 2023
Other outcomes:
Locations:
Study officials:
affiliation: professor of dignostic radiology
name: Samy abdelaziz
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. doi: 10.7863/ultra.15.11093. Epub 2016 Oct 25.
citation: 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.