Clinical trial NCT06207188: Identification and Differentiation of Thyroid Nodules by Acoustic Imaging and Viscoelastic Parameters
Official title: Identification and Differentiation of Thyroid Nodules by Acoustic Imaging and Viscoelastic Parameters
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Thyroid Gland Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2024-01-16
Enrollment: 650
Sex: ALL
Minimum age (years): 8
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

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.

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

Primary outcomes:
measure: Incidence of nodules successfully sited by vibro-acoustography (VA)
timeFrame: Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation
measure: Specificity of VA in differentiating malignant and benign of thyroid nodules
timeFrame: Baseline, 3 months post ablation, 6 months post ablation, 12 months post ablation
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Azra Alizad, MD
role: PRINCIPAL_INVESTIGATOR
References: