NCT04561999

Brief 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Feb 2021

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 14, 2020

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
4 months until next milestone

Study Start

First participant enrolled

February 1, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2021

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

January 26, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

September 14, 2020

Last Update Submit

January 23, 2021

Conditions

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    one year

Study Arms (1)

Patients with Superficial Lymphadenopathy

Device: Elastography

Interventions

Performance of Ultrasound, Elastography

Patients with Superficial Lymphadenopathy

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

patients with enlarged lymph nodes.

You may qualify if:

  • Patients presented with enlarged lymph nodes by clinical examination.

You may not qualify if:

  • Patients who previously receive any medical treatment or chemo or radiotherapy.
  • Patients who previously underwent fine needle aspiration cytology or biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • 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.

    PMID: 30774094BACKGROUND
  • Acu 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.

    PMID: 27794132BACKGROUND
  • Naik 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.

    PMID: 24431828BACKGROUND
  • Suh 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.

    PMID: 27147221BACKGROUND
  • Desmots 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.

    PMID: 26617244BACKGROUND
  • Bhatia 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.

    PMID: 23876352BACKGROUND
  • Cheng 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.

    PMID: 26553206BACKGROUND
  • Choi 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.

    PMID: 23453381BACKGROUND

Related Links

MeSH Terms

Interventions

Elasticity Imaging Techniques

Intervention Hierarchy (Ancestors)

UltrasonographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosis

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 14, 2020

First Posted

September 24, 2020

Study Start

February 1, 2021

Primary Completion

October 1, 2021

Study Completion

October 1, 2022

Last Updated

January 26, 2021

Record last verified: 2021-01