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

ConditionThyroid Gland Carcinoma

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age8+

SponsorMayo Clinic

About this trial

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

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

* 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

Disqualifiers

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

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Non-Interventional Study
Other intervention
Non-interventional study

Treatment groups

650 Participants

are divided into 1 treatment group

Group A: Observational1 intervention

Trial outcomes

Primary outcomes

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).

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

Specificity of VA in differentiating malignant and benign of thyroid nodules will be determined by comparing the VA image to the US image.

Time frame

Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov

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