Salivary Gland DiseasesNCT05151029
Elastography in the Evaluation of Major Salivary Gland Lesions
An observational study of Salivary Gland Diseases, run by Assiut University.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Salivary Gland Diseases
- What is being tested?
- Elastography
- Type of treatment
- Medical device
- How many people
- 34 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2022to 1 Oct 2023
- Phase
- Observational
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 Any age
- All sexes
- Child, Adult, Older adult
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.
Who may be able to join
- 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 .
Who cannot join
- A mass with ulcerated or raw surface, involvement of the whole gland by the lesion or previous surgical treatment
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Role of Real Time Elastography in the Evaluation of Major Salivary Gland Lesions
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.
Read the 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.
- Conditions
- Salivary Gland Diseases
- Being tested
- Elastography
- 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.
ElastographyDevice
new dignostic tool
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: from october 2022 to october 2023
Secondary outcomes (1)
Elastography importance in salivary gland disease
Differentiation of Salivary gland masses
Measured: From October 2022 to October 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2021
- Study start1 Sep 2022 (estimated)
- Primary completion1 Sep 2023 (estimated)
- Study completion1 Oct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramy Refaat Ayoub Eshak, Assiut University
- Investigators
- Samy abdelaziz, Principal investigator, professor of dignostic radiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05151029
- Sponsor's protocol ID
- Major salivary gland lesions
- Status last verified
- Nov 2021
- First submitted
- 5 Nov 2021
- Last updated
- 9 Dec 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 22021543Zhou 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.
PubMed 27872416Karaman 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.
PubMed 30426518