Thyroid Gland Carcinoma
Conditions
Brief summary
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
OTHERNon-Interventional Study
Non-interventional study
Sponsors
Mayo Clinic
National Cancer Institute (NCI)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
8 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of nodules successfully sited by vibro-acoustography (VA) | Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation | 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). |
| Specificity of VA in differentiating malignant and benign of thyroid nodules | Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation | Specificity of VA in differentiating malignant and benign of thyroid nodules will be determined by comparing the VA image to the US image. |
Countries
United States
Contacts
CONTACTClinical Trials Referral Office
PRINCIPAL_INVESTIGATORAzra Alizad, MD
Mayo Clinic in Rochester
Outcome results
None listed