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

Thyroid Gland Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06207188
• Other study ID #: 08-008778
• Secondary ID: NCI-2023-1084208
• Status: Recruiting
• Start date: May 17, 2009
• Est. completion date: December 31, 2026

Study information

• Verified date: January 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 650
• Est. completion date: December 31, 2026
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Gland Carcinoma
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

Other:
• Non-Interventional Study
Non-interventional study

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	Mayo Clinic in Rochester	Rochester	Minnesota
United States	Mayo Clinic in Arizona	Scottsdale	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of nodules successfully sited by vibro-acoustography (VA)	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).	Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation
Primary	Specificity of VA in differentiating malignant and benign of thyroid nodules	Specificity of VA in differentiating malignant and benign of thyroid nodules will be determined by comparing the VA image to the US image.	Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation

External Links

•   Mayo Clinic Clinical Trials