Ultrasound Elastography in Imaging Patients With Thyroid Nodules

Not Applicable

Completed

• Conditions: Thyroid Gland Nodule; Malignant Thyroid Gland Neoplasm
• Interventions: Device: Siemens Acuson S3000 ultrasound system

• Registration Number: NCT03174925
• Lead Sponsor: Stanford University

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2014-01-24
• Study First Submitted: 2017-05-18
• Study First Submitted QC: 2017-05-31
• Study First Posted: 2017-06-05
• Primary Completion: 2018-02-13
• Study Completion: 2019-02-13
• Results First Submitted: 2021-05-18
• Status Verified: 2021-06
• Results First Submitted QC: 2021-06-16
• Last Update Submitted: 2021-06-16
• Results First Posted: 2021-07-08
• Last Update Posted: 2021-07-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tissue Stiffness by Elastography	Siemens Acuson S3000 ultrasound system	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.

Primary Outcome Measures

Name	Time	Method
Stiffness of Thyroid Nodules as Measured by Elastography	1 week	Potentially cancerous thyroid nodules will be assessed elastographically, and cancer status will be determined from a fine needle aspiration biopsy results or the surgically excised nodule. The outcome will be reported as median tissue stiffness with standard deviation for nodules that were determined non-cancerous (benign), cancerous, or indeterminate.

Trial Locations

Locations (1)

Stanford University, School of Medicine; 🇺🇸 Palo Alto, California, United States