Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06207188

Identification and Differentiation of Thyroid Nodules by Acoustic Imaging and Viscoelastic Parameters

This study is being done to identify and differentiate thyroid nodules by acoustic imaging and viscoelastic parameters.

Recruiting

Interested in participating?

Request Info

Key information

Age range

8 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Mayo Clinic in Arizona, Scottsdale, Arizona, United States

Loading trial locations.

About this study

PRIMARY OBJECTIVES:

I. Identification of thyroid nodules by vibro-acoustography - Determine detection rate.

II. Evaluate the specificity of VA in differentiating malignant and benign of thyroid nodules - Compare the result to that of ultrasound (US).

III. Assess diagnostic value of Shear Wave Ultrasound Vibrometry (SDUV) and Comb Push shear elastography (CUSE) in differentiation of thyroid nodules - correlate SDUV and CUSE results to pathology.

IV. Test and compare the results shear wave imaging with new FDA approved ultrasound device called SuperSonic Imagine Aixplorer.

V. Assess diagnostic value of Shear Wave Ultrasound Vibrometry (SDUV) and Comb Push shear elastography (CUSE) in differentiation of palpable and sonographically detectable cervical lymph nodes or non-thyroidal neck masses.

VI. Assess the diagnostic values of ultrasound quantitative microvessel imaging for differentiation of thyroid nodules and cervical lymph nodes.

VII. Assess the response to alcohol ablation on patients with recurrent thyroid cancer on thyroid bed or new lymph nodes on neck.

OUTLINE: This is an observational study.

Patients undergo ultrasound imaging on study.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • * Male and female patient volunteers ages 8 and up who are suspicious for thyroid cancer
  • Patients who have palpable and sonographically detectable lymph nodes or nonthyroidal neck masses and are referred to Radiology Department or Endocrinology for fine-needle aspiration biopsy (FNAB)
  • Patients 18 and up who were previously diagnosed with thyroid cancer and treated with thyroidectomy and recently diagnosed as having recurrence nodes on thyroid bed or on their neck

Exclusion criteria

  • Because thyroid cancer is rare under the age of 8 years, children younger than this age are excluded from the study
  • Having FNAB or surgical biopsy on thyroid in less than two weeks for thyroid nodule detection group
  • Having FNAB or surgical biopsy on cervical lymph nodes or non- thyroidal masses for this group of patients

Treatment and study plan

Non-Interventional Study

Other

Non-interventional study

Primary outcomes

  1. Incidence of nodules successfully sited by vibro-acoustography (VA)

    Time frame: Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation

    Successful nodule localization will be assessed by the review of the VA image relative to the nodule location information from the reference ultrasound (US) image (agree/disagree on location will be determined for each nodule).

  2. Specificity of VA in differentiating malignant and benign of thyroid nodules

    Time frame: Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation

    Specificity of VA in differentiating malignant and benign of thyroid nodules will be determined by comparing the VA image to the US image.

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Referral Office

CONTACT

[email protected]

855-776-0015

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Important dates

Study start
2009
Primary completion
2026
Study completion
2026
First posted
Jan 16, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.