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

Recruiting

• Conditions: Thyroid Gland Carcinoma
• Interventions: Other: Non-Interventional Study

• Registration Number: NCT06207188
• Lead Sponsor: Mayo Clinic

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study Start: 2009-05-17
• Study First Submitted: 2024-01-03
• Study First Submitted QC: 2024-01-11
• Study First Posted: 2024-01-16
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-22
• Last Update Posted: 2024-11-26
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 650

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Observational	Non-Interventional Study	Patients undergo ultrasound imaging on study.

Primary Outcome Measures

Name	Time	Method
Specificity of VA in differentiating malignant and benign of thyroid nodules	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.
Incidence of nodules successfully sited by vibro-acoustography (VA)	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).

Trial Locations

Locations (3)

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States