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| ID | Type | Description | Link |
|---|---|---|---|
| R01CA148994 | U.S. NIH Grant/Contract | View source | |
| NCI-2023-10842 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 08-008778 | Other Identifier | Mayo Clinic Institutional Review Board |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This study is being done to identify and differentiate thyroid nodules by acoustic imaging and viscoelastic parameters.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients undergo ultrasound imaging on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
* Male and female patient volunteers ages 8 and up who are suspicious for thyroid cancer
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Referral Office | Contact | 855-776-0015 | mayocliniccancerstudies@mayo.edu |
| Name | Affiliation | Role |
|---|---|---|
| Azra Alizad, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Recruiting | Scottsdale | Arizona | 85259 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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| Mayo Clinic in Florida | Recruiting | Jacksonville | Florida | 32224-9980 | United States |
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| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |