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

Mayo Clinic

Status: Enrolling

Conditions: Thyroid Gland Carcinoma

Treatments: Other: Non-Interventional Study

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT06207188

R01CA148994 (U.S. NIH Grant/Contract)

08-008778 (Other Identifier)

NCI-2023-10842 (Registry Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 650 estimated patients

Sex: All

Ages: 8+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

650 participants in 1 patient group

Observational

Description:

Patients undergo ultrasound imaging on study.

Treatment:

Other: Non-Interventional Study