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

NCT06207188 | Recruiting

• 3 other identifiers: 08-008778R01CA148994NCI-2023-10842
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Thyroid Gland Carcinoma

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Observational

Patients undergo ultrasound imaging on study.

Other: Non-Interventional Study

Interventions

Non-Interventional Study OTHER

Non-interventional study

Observational

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patient volunteers ages 8 and up who are suspicious for thyroid cancer or a group of patients who have palpable and sonographically detectable lymph nodes or nonthyroidal neck masses or 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.

You may qualify if:

• \* 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

Mayo Clinic in Arizona

Scottsdale, Arizona, 85259, United States

RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, 32224-9980, United States

RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Study Officials

• Azra Alizad, MD

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Clinical Trials Referral Office

CONTACT

855-776-0015; mayocliniccancerstudies@mayo.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2024
• First Posted: January 16, 2024
• Study Start: May 17, 2009
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (3)