Superficial LymphadenopathyNCT04561999
Elastography in Superficial Lymphadenopathy
An observational study of Superficial Lymphadenopathy, run by Assiut University.
Trial summary
Evaluation of the role of Ultrasound Elastography in differentiation between benign and malignant lymph nodes and its additional information over the classic gray scale and color Doppler ultrasound. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Superficial Lymphadenopathy
- What is being tested?
- Elastography
- Type of treatment
- Medical device
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2021to 1 Oct 2022
- 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 with enlarged lymph nodes.
Who may be able to join
- Patients presented with enlarged lymph nodes by clinical examination.
Who cannot join
- Patients who previously receive any medical treatment or chemo or radiotherapy.
- Patients who previously underwent fine needle aspiration cytology or biopsy.
About this study
Official title: Value of Ultrasound Elastography in Characterization of Superficial Lymphadenopathy
Evaluation of the role of Ultrasound Elastography in differentiation between benign and malignant lymph nodes and its additional information over the classic gray scale and color Doppler ultrasound.
Read the detailed description
Lymph nodes are part of the body immune system which are located throughout the body including head and neck, armpit, and groin.
Lymphadenopathy is defined as an abnormality in the size or character of lymph nodes caused by the invasion or propagation of either inflammatory or neoplastic cells into the nodes.
The differentiation of malignant from benign lymph nodes is essential because it predicts the patient prognosis and help in the decision making regarding the management plan.
On ultrasound, gray scale sonography helps to evaluate nodal morphology, whilst color doppler is used to assess vascular pattern. The qualitative criteria for malignancy were heterogenous hypoechoic cortex, irregular margins, lack of hyperechoic fatty hilum and abnormal blood vessels penetrating the lymph nodes capsule.The avascular or hilar patterns were defined as LNs with normal vascularity pattern, and the peripheral or mixed (peripheral and hilar) pattern as LNs with abnormal vascularity pattern. On B-mode and color doppler ultrasound, there is no specific criteria for differentiating metastatic lymph nodes from reactive lymph nodes with 100% accuracy.
Fine-needle aspiration biopsy is the reference standard for differentiating metastatic lymph nodes from reactive lymph nodes. However, restrictions of fine-needle aspiration biopsy are that it is an invasive procedure, and it is not possible to perform for lymph nodes smaller than 5 mm.Therefore, a simple, reliable, and non-invasive imaging modality for differentiating malignant lymph nodes is required.
Ultrasound elastography (UE) is a rather new, non-invasive imaging technique that can be used to depict tissue stiffness and elastic properties. Ultrasound elastography (UE) can be divided broadly into 2 groups depending on the type of tissue displacement:
- Strain elastography (SE): measures tissue displacements along the axis of an applied force.Strain elastography provides semi - quantitative scores based on elastographic pattern (scores based on percentage of stiff area within the lesion) and strain ratio (ratio between the lesion and the background tissue).
- Shear wave elastography (SWE): measures a different type of waves that is also produced when tissues are mechanically stimulated. Shear wave elastography is also a quantitative method of analysis for elasticity images using shear wave speed (m/s) or elastic modulus (kPa).
Ultrasound elastography (UE) is easy, rather cheap, non-invasive, and quick to perform, well tolerated by patients, and offers a strong diagnostic power.
- Conditions
- Superficial Lymphadenopathy
- Being tested
- Elastography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElastographyDevice
Performance of Ultrasound, Elastography
| Study group | Role | What they receive |
|---|---|---|
| Patients with Superficial Lymphadenopathy | Not described Receives: Device: Elastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the role of Ultrasound Elastography in differentiation between benign and malignant lymph nodes by its additional information over the classic gray scale and color Doppler ultrasound.
Strain elastography (SE): measures tissue displacements along the axis of an applied force. Strain elastography provides semi - quantitative scores based on elastographic pattern (scores based on percentage of stiff area within the lesion) and strain ratio (ratio between the lesion and the background tissue).
Measured: one year
To evaluate the role of Ultrasound Elastography in differentiation between benign and malignant lymph nodes by its additional information over the classic gray scale and color Doppler ultrasound.
Shear wave elastography (SWE): measures a different type of waves that is also produced when tissues are mechanically stimulated. Shear wave elastography is also a quantitative method of analysis for elasticity images using shear wave speed (m/s).
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study start1 Feb 2021 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Oct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Superficial LymphadenopathyStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermin Gamal Eldin Ahmed Abdel Sattar, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04561999
- Sponsor's protocol ID
- Ultrasound in Lymphadenopathy
- Status last verified
- Jan 2021
- First submitted
- 14 Sep 2020
- Last updated
- 26 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kilic A, Colakoglu Er H. Virtual touch tissue imaging quantification shear wave elastography for determining benign versus malignant cervical lymph nodes: a comparison with conventional ultrasound. Diagn Interv Radiol. 2019 Mar;25(2):114-121. doi: 10.5152/dir.2019.18406.
PubMed 30774094Acu L, Oktar SO, Acu R, Yucel C, Cebeci S. Value of Ultrasound Elastography in the Differential Diagnosis of Cervical Lymph Nodes: A Comparative Study With B-mode and Color Doppler Sonography. J Ultrasound Med. 2016 Nov;35(11):2491-2499. doi: 10.7863/ultra.15.09019.
PubMed 27794132Naik RM, Pai A, Guruprasad Y, Singh R. Efficacy of colour Doppler ultrasound in diagnosis of cervical lymphadenopathy. J Maxillofac Oral Surg. 2013 Jun;12(2):123-9. doi: 10.1007/s12663-012-0395-1. Epub 2012 Aug 24.
PubMed 24431828Suh CH, Choi YJ, Baek JH, Lee JH. The diagnostic performance of shear wave elastography for malignant cervical lymph nodes: A systematic review and meta-analysis. Eur Radiol. 2017 Jan;27(1):222-230. doi: 10.1007/s00330-016-4378-3. Epub 2016 May 5.
PubMed 27147221Desmots F, Fakhry N, Mancini J, Reyre A, Vidal V, Jacquier A, Santini L, Moulin G, Varoquaux A. Shear Wave Elastography in Head and Neck Lymph Node Assessment: Image Quality and Diagnostic Impact Compared with B-Mode and Doppler Ultrasonography. Ultrasound Med Biol. 2016 Feb;42(2):387-98. doi: 10.1016/j.ultrasmedbio.2015.10.019. Epub 2015 Nov 23.
PubMed 26617244Bhatia KS, Lee YY, Yuen EH, Ahuja AT. Ultrasound elastography in the head and neck. Part I. Basic principles and practical aspects. Cancer Imaging. 2013 Jul 22;13(2):253-9. doi: 10.1102/1470-7330.2013.0026.
PubMed 23876352Cheng KL, Choi YJ, Shim WH, Lee JH, Baek JH. Virtual Touch Tissue Imaging Quantification Shear Wave Elastography: Prospective Assessment of Cervical Lymph Nodes. Ultrasound Med Biol. 2016 Feb;42(2):378-86. doi: 10.1016/j.ultrasmedbio.2015.10.003. Epub 2015 Nov 6.
PubMed 26553206Choi YJ, Lee JH, Lim HK, Kim SY, Han MW, Cho KJ, Baek JH. Quantitative shear wave elastography in the evaluation of metastatic cervical lymph nodes. Ultrasound Med Biol. 2013 Jun;39(6):935-40. doi: 10.1016/j.ultrasmedbio.2012.12.009. Epub 2013 Feb 27.
PubMed 23453381
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Value of Ultrasound Elastography in Characterization of Superficial Lymphadenopathy
- ClinicalTrials.gov ID
- NCT04561999
- Acronym / sponsor ID
- Ultrasound in Lymphadenopathy
- Conditions
- Superficial Lymphadenopathy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Feb 2021 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Oct 2022 (estimated)
- First posted
- 24 Sep 2020 (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.
Evaluation of the role of Ultrasound Elastography in differentiation between benign and malignant lymph nodes and its additional information over the classic gray scale and color Doppler ultrasound.
Detailed description
Lymph nodes are part of the body immune system which are located throughout the body including head and neck, armpit, and groin.
Lymphadenopathy is defined as an abnormality in the size or character of lymph nodes caused by the invasion or propagation of either inflammatory or neoplastic cells into the nodes.
The differentiation of malignant from benign lymph nodes is essential because it predicts the patient prognosis and help in the decision making regarding the management plan.
On ultrasound, gray scale sonography helps to evaluate nodal morphology, whilst color doppler is used to assess vascular pattern. The qualitative criteria for malignancy were heterogenous hypoechoic cortex, irregular margins, lack of hyperechoic fatty hilum and abnormal blood vessels penetrating the lymph nodes capsule.The avascular or hilar patterns were defined as LNs with normal vascularity pattern, and the peripheral or mixed (peripheral and hilar) pattern as LNs with abnormal vascularity pattern. On B-mode and color doppler ultrasound, there is no specific criteria for differentiating metastatic lymph nodes from reactive lymph nodes with 100% accuracy.
Fine-needle aspiration biopsy is the reference standard for differentiating metastatic lymph nodes from reactive lymph nodes. However, restrictions of fine-needle aspiration biopsy are that it is an invasive procedure, and it is not possible to perform for lymph nodes smaller than 5 mm.Therefore, a simple, reliable, and non-invasive imaging modality for differentiating malignant lymph nodes is required.
Ultrasound elastography (UE) is a rather new, non-invasive imaging technique that can be used to depict tissue stiffness and elastic properties. Ultrasound elastography (UE) can be divided broadly into 2 groups depending on the type of tissue displacement:
- Strain elastography (SE): measures tissue displacements along the axis of an applied force.Strain elastography provides semi - quantitative scores based on elastographic pattern (scores based on percentage of stiff area within the lesion) and strain ratio (ratio between the lesion and the background tissue).
- Shear wave elastography (SWE): measures a different type of waves that is also produced when tissues are mechanically stimulated. Shear wave elastography is also a quantitative method of analysis for elasticity images using shear wave speed (m/s) or elastic modulus (kPa).
Ultrasound elastography (UE) is easy, rather cheap, non-invasive, and quick to perform, well tolerated by patients, and offers a strong diagnostic power.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Superficial Lymphadenopathy | – | Device: Elastography |
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- patients with enlarged lymph nodes.
Key inclusion criteria (1 listed)
- Patients presented with enlarged lymph nodes by clinical examination.
Key exclusion criteria (2 listed)
- Patients who previously receive any medical treatment or chemo or radiotherapy.
- Patients who previously underwent fine needle aspiration cytology or biopsy.
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 |
|---|---|---|
| ElastographyPerformance of Ultrasound, Elastography | Device | Patients with Superficial Lymphadenopathy |
Primary outcome
To evaluate the role of Ultrasound Elastography in differentiation between benign and malignant lymph nodes by its additional information over the classic gray scale and color Doppler ultrasound.
Time frame: one year
Strain elastography (SE): measures tissue displacements along the axis of an applied force. Strain elastography provides semi - quantitative scores based on elastographic pattern (scores based on percentage of stiff area within the lesion) and strain ratio (ratio between the lesion and the background tissue).
To evaluate the role of Ultrasound Elastography in differentiation between benign and malignant lymph nodes by its additional information over the classic gray scale and color Doppler ultrasound.
Time frame: one year
Shear wave elastography (SWE): measures a different type of waves that is also produced when tissues are mechanically stimulated. Shear wave elastography is also a quantitative method of analysis for elasticity images using shear wave speed (m/s).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2021.
- Background: PubMed 30774094Kilic A, Colakoglu Er H. Virtual touch tissue imaging quantification shear wave elastography for determining benign versus malignant cervical lymph nodes: a comparison with conventional ultrasound. Diagn Interv Radiol. 2019 Mar;25(2):114-121. doi: 10.5152/dir.2019.18406.
- Background: PubMed 27794132Acu L, Oktar SO, Acu R, Yucel C, Cebeci S. Value of Ultrasound Elastography in the Differential Diagnosis of Cervical Lymph Nodes: A Comparative Study With B-mode and Color Doppler Sonography. J Ultrasound Med. 2016 Nov;35(11):2491-2499. doi: 10.7863/ultra.15.09019.
- Background: PubMed 24431828Naik RM, Pai A, Guruprasad Y, Singh R. Efficacy of colour Doppler ultrasound in diagnosis of cervical lymphadenopathy. J Maxillofac Oral Surg. 2013 Jun;12(2):123-9. doi: 10.1007/s12663-012-0395-1. Epub 2012 Aug 24.
- Background: PubMed 27147221Suh CH, Choi YJ, Baek JH, Lee JH. The diagnostic performance of shear wave elastography for malignant cervical lymph nodes: A systematic review and meta-analysis. Eur Radiol. 2017 Jan;27(1):222-230. doi: 10.1007/s00330-016-4378-3. Epub 2016 May 5.
- Background: PubMed 26617244Desmots F, Fakhry N, Mancini J, Reyre A, Vidal V, Jacquier A, Santini L, Moulin G, Varoquaux A. Shear Wave Elastography in Head and Neck Lymph Node Assessment: Image Quality and Diagnostic Impact Compared with B-Mode and Doppler Ultrasonography. Ultrasound Med Biol. 2016 Feb;42(2):387-98. doi: 10.1016/j.ultrasmedbio.2015.10.019. Epub 2015 Nov 23.
- Background: PubMed 23876352Bhatia KS, Lee YY, Yuen EH, Ahuja AT. Ultrasound elastography in the head and neck. Part I. Basic principles and practical aspects. Cancer Imaging. 2013 Jul 22;13(2):253-9. doi: 10.1102/1470-7330.2013.0026.
- Background: PubMed 26553206Cheng KL, Choi YJ, Shim WH, Lee JH, Baek JH. Virtual Touch Tissue Imaging Quantification Shear Wave Elastography: Prospective Assessment of Cervical Lymph Nodes. Ultrasound Med Biol. 2016 Feb;42(2):378-86. doi: 10.1016/j.ultrasmedbio.2015.10.003. Epub 2015 Nov 6.
- Background: PubMed 23453381Choi YJ, Lee JH, Lim HK, Kim SY, Han MW, Cho KJ, Baek JH. Quantitative shear wave elastography in the evaluation of metastatic cervical lymph nodes. Ultrasound Med Biol. 2013 Jun;39(6):935-40. doi: 10.1016/j.ultrasmedbio.2012.12.009. Epub 2013 Feb 27.
- Related InfoLink provided by the sponsor.
Related trials for Superficial Lymphadenopathy
RecruitingObservational study
Value of Super-resolution Ultrasonography in Differentiating Benign and Malignant Lymph Nodes
Lymphadenopathy, Lymphnode Metastasis
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Superficial Lymphadenopathy, 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 1 inclusion and 2 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 26 Jan 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To evaluate the role of Ultrasound Elastography in differentiation between benign and malignant lymph nodes by its additional information over the classic gray scale and color Doppler ultrasound. (time frame: one year). 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 NCT04561999, which also lists 8 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 26 Jan 2021.