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

NCT ID: NCT06207188

Last Updated: 2025-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-17

Study Completion Date

2026-12-31

Brief Summary

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

Detailed Description

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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.

Conditions

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Thyroid Gland Carcinoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational

Patients undergo ultrasound imaging on study.

Non-Interventional Study

Intervention Type OTHER

Non-interventional study

Interventions

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Non-Interventional Study

Non-interventional study

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Azra Alizad, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Site Status RECRUITING

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Clinical Trials Referral Office

Role: CONTACT

855-776-0015

Facility Contacts

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Clinical Trials Referral Office

Role: primary

855-776-0015

Clinical Trials Referral Office

Role: primary

855-776-0015

Clinical Trials Referral Office

Role: primary

855-776-0015

Related Links

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Other Identifiers

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R01CA148994

Identifier Type: NIH

Identifier Source: secondary_id

View Link

NCI-2023-10842

Identifier Type: REGISTRY

Identifier Source: secondary_id

08-008778

Identifier Type: OTHER

Identifier Source: secondary_id

08-008778

Identifier Type: -

Identifier Source: org_study_id

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