Ultrasound Elastography in Imaging Patients With Thyroid Nodules

Stanford University

Status: Completed

Conditions: Thyroid Gland Nodule; Malignant Thyroid Gland Neoplasm

Treatments: Device: Siemens Acuson S3000 ultrasound system

Study type: Interventional

Funder types: Other

Identifiers

NCT03174925

IRB-23634

END0020 (Other Identifier)

NCI-2017-00841 (Registry Identifier)

Details and patient eligibility

About

This clinical trial studies how well ultrasound elastography works in assessing the cancer status of potentially malignant thyroid nodules.

Full description

PRIMARY OBJECTIVES:

Determine the utility of ultrasound elastography in evaluation of thyroid nodules being evaluated for the presence of cancer.

Elastography measures the passages of ultrasound shear waves through tissue to gauge the stiffness and compressibility of the tissue, collectively "tissue stiffness," and may be a better way to image thyroid nodules. Tissue stiffness is a physiological parameter that is being evaluated for differences between non-cancerous (benign) and cancerous thyroid nodules.

Participants will undergo elastography over the 10 minutes prior to either fine needle aspiration of a biopsy specimen or surgical resection of the thyroid nodule. Tissue specimens from the biopsy specimen or surgical resection will be assessed pathologically to determine actual cancer status.

Enrollment: 55 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Presence of a thyroid nodule that is amenable to ultrasound guided fine needle aspiration

Exclusion criteria

• Patients who are unable to lie supine for a biopsy
• Pregnant patients

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Tissue Stiffness by Elastography

Experimental group

Description:

Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status.

Treatment:

Device: Siemens Acuson S3000 ultrasound system