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
- Are there results?
- None posted in the registry
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Real Time Elastography in the Evaluation of Major Salivary Gland Lesions
- ClinicalTrials.gov ID
- NCT05151029
- Acronym / sponsor ID
- Major salivary gland lesions
- Conditions
- Salivary Gland Diseases
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 1 Sep 2023 (estimated)
- Study completion
- 1 Oct 2023 (estimated)
- First posted
- 9 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- 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.
Key inclusion criteria (2 listed)
- 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 .
Key exclusion criteria (1 listed)
- A mass with ulcerated or raw surface, involvement of the whole gland by the lesion or previous surgical treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Elastographynew dignostic tool | Device | – |
Primary outcome
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
Time frame: from october 2022 to october 2023
Use of elastography in major salivarygland lesions benign or malignant
-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
Time frame: from october 2022 to october 2023
Differentiation between salivary gland lesions
1 secondary outcome
Elastography importance in salivary gland disease
Time frame: From October 2022 to October 2023
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Background: PubMed 22021543Dumitriu 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.
- Background: PubMed 27872416Zhou 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.
- Background: PubMed 30426518Karaman 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samy abdelaziz principal investigator
professor of dignostic radiology
Questions about this trial
What is this clinical trial studying?
An observational study of Salivary Gland Diseases, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ramy refaat, master (01008608677, ramyrefaatayoub@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (time frame: from october 2022 to october 2023). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05151029, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2021.