Ultrasound Elastography in Imaging Patients With Thyroid Nodules

Thyroid Gland Nodule Clinical Trial

Official title:

Elastography in Thyroid Nodule Evaluation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03174925
• Other study ID #: IRB-23634
• Secondary ID: NCI-2017-00841EN
• Status: Completed
• Phase: N/A
• Start date: January 24, 2014
• Est. completion date: February 13, 2019

Study information

• Verified date: June 2021
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: February 13, 2019
• Est. primary completion date: February 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Malignant Thyroid Gland Neoplasm
• Thyroid Diseases
• Thyroid Gland Nodule
• Thyroid Neoplasms
• Thyroid Nodule

Intervention

Device:
• Siemens Acuson S3000 ultrasound system
Shear Wave Elastography

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Stiffness of Thyroid Nodules as Measured by Elastography	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.	1 week