Elastography in Thyroid Nodules

Sponsor
Assiut University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04312646
Collaborator
(none)
50
24

Study Details

Study Description

Brief Summary

Thyroid nodules are a common finding in the general population,however, they are mostly unpalpable and usually discovered either during neck ultrasound (US) examination or by pathological examination at autopsy. They are found in about 8% of adults. Most thyroid nodules ''incidentalomas" are benign, however 7% may be malignant. Early detection of thyroid cancer helps in early treatment and better survival US is an accurate method for detection of thyroid nodules; however, US has a low accuracy in differentiating between benign from malignant thyroid nodules . US could suggest a malignancy likelihood criteria of a thyroid nodule, such as hypoechogenicity, increased intranodular vascularity, irregular margins, microcalcifications, absent halo, and a taller-than-wide shape measured in the transverse dimension.

Condition or Disease Intervention/Treatment Phase
  • Device: Elastography .

Detailed Description

US elastography has been used to detect the nature of thyroid nodules, by measuring the tissue stiffness non invasively. It depends on tissue deformation strain that is caused by external compression.it is complementary to gray scale findings particularly in nodules with indeterminate US findings, also US elastography could be used to guide the follow up of leisons diagnosed as benign at ( FNA) fine needle aspiration .

There are two main thyroid elastography methods in clinical practice: strain elastography (SE) and shear-wave elastography (SWE) .

Elastography methods can be classified into different variants based on the excitation method (external force, internal force, and acoustic radiation force [ARF]), and how stiffness is expressed . (A) strain elastography . SE reqires mechanical stress, which results in axial displacement of the tissue Tissue deformation from the stress is measured and visualized on a screen. The main limitations of SE are operator dependence for the angle, strength, and duration of compression.

(B) shear wave elastography . The acoustic pulses from the probe stimulate the target tissue, creating a shear wave (SW) traveling perpendicular to the conventional US waves. SWs are the transverse components of particle displacement that are rapidly attenuated by the tissue (1- 10 m/sec). This transverse component is tracked and measured as a numerical value corresponding to the shear-wave speed (SWS).This speed is closely related to the Young modulus formula, in which tissue elasticity can be assessed from the SW propagation.

US elastography is completely painless for the patient, and only requires a few extra minutes, with no separate patient preparation. US elastography has the potential to distinguish benign from malignant TNs, offering non-invasive complementary information to conventional US.

It may be particularly useful in patients who have nondiagnostic or indeterminate FNA cytology results.

Study Design

Study Type:
Observational
Anticipated Enrollment :
50 participants
Observational Model:
Case-Only
Time Perspective:
Cross-Sectional
Official Title:
Added Value of Ultrasound Elasatography in Characterization of Thyroid Nodules
Anticipated Study Start Date :
Apr 1, 2020
Anticipated Primary Completion Date :
Apr 1, 2021
Anticipated Study Completion Date :
Apr 1, 2022

Arms and Interventions

Arm Intervention/Treatment
patients with thyroid nodules

Device: Elastography .
Performance of US, elastography

Outcome Measures

Primary Outcome Measures

  1. To evaluate the role of Elastography in differentiation between benign and malignant thyroid nodules [one year]

    by its additional information over the classic gray scale and color Doppler ultrasound

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • solitary nodule on clinical or ultrasound examination
Exclusion Criteria:
  • Patients received any medical treatment or chemo or radiotherapy.

  • Patients underwent fine needle aspiration cytology or biopsy

  • Nodules with calcification and cystic changes

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Omima mahran hussein abd el wadod, principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT04312646
Other Study ID Numbers:
  • ultrasound in thyroid nodules
First Posted:
Mar 18, 2020
Last Update Posted:
Mar 18, 2020
Last Verified:
Mar 1, 2020
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 18, 2020