Identification and Differentiation of Thyroid Nodules by Acoustic Imaging and Viscoelastic Parameters
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Non-Interventional Study.
- Who it may be relevant to
- Registry conditions: Thyroid Gland Carcinoma. Basic parameters: from 8 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other Non-Interventional Study
Non-interventional study
Primary outcome measures
- Incidence of nodules successfully sited by vibro-acoustography (VA) [Time frame: Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation]
- Specificity of VA in differentiating malignant and benign of thyroid nodules [Time frame: Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Observational model
- Cohort
Study locations
United States · 3 centers
- Mayo Clinic in Arizona — Scottsdale
- Mayo Clinic in Florida — Jacksonville
- Mayo Clinic in Rochester — Rochester
Identifiers
NCT: NCT06207188 · 08-008778 · R01CA148994 · NCI-2023-10842 · 08-008778