Identification and Differentiation of Thyroid Nodules by Acoustic Imaging and Viscoelastic Parameters
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
Study Locations
-
-
Arizona
-
Scottsdale, Arizona, United States, 85259
- Recruiting
- Mayo Clinic in Arizona
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Nirvikar Dahiya, M.D.
-
-
Florida
-
Jacksonville, Florida, United States, 32224-9980
- Recruiting
- Mayo Clinic in Florida
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
Principal Investigator:
- Melanie P. Caserta, MD
-
-
Minnesota
-
Rochester, Minnesota, United States, 55905
- Recruiting
- Mayo Clinic in Rochester
-
Principal Investigator:
- Azra Alizad, MD
-
Contact:
- Clinical Trials Referral Office
- Phone Number: 855-776-0015
- Email: mayocliniccancerstudies@mayo.edu
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Observational
Patients undergo ultrasound imaging on study.
|
Non-interventional study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Incidence of nodules successfully sited by vibro-acoustography (VA)
Time Frame: 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).
|
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
|
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
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Azra Alizad, MD, Mayo Clinic in Rochester
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 08-008778 (Other Identifier: Mayo Clinic Institutional Review Board)
- NCI-2023-10842 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
- R01CA148994 (U.S. NIH Grant/Contract)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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