Thyroid Ultrasound Elasticity (TrUE) Imaging

NCT03307694 | Completed FDA Device

• 1 other identifier: IRB00092785
• Study Type: observational
• Target: 31
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the researchers will scan the thyroid nodules of patients scheduled for surgical removal of these nodules. During their preadmission testing, but prior to their surgery, the researchers will perform standard ultrasound and shear wave elasticity imaging (SWEI) scans of the thyroid nodules in these patients. Both images can be generated by the same ultrasound scanner and within the same imaging session without having to switch out any equipment. The results of the SWEI scans will be compared to the definitive diagnosis from pathology obtained after pathologists have examined the removed nodules post-operatively.

Conditions

Cancer, Thyroid

Keywords

Cancer; Thyroid nodule; Imaging; Radiology

Outcome Measures

Primary Outcomes (2)

• Determination of Malignancy by SWEI Imaging

  As part of the pre-operative visit, participants will have imaging of their thyroid nodules. Established SWEI and MAC-SWEI techniques will be performed to identify malignant thyroid tissue.

  Pre-operative visit (within 24 hours before surgery, on average)

• Determination of Malignancy by Pathological Proof

  Tissue samples obtained during the participant's thyroid biopsy, thyroidectomy, or cervical node biopsy will be submitted to the pathology lab as part of the clinical standard of care. The pathology report will specify whether or not malignant cells were found in the tissue sample.

  Post-surgery (within 10 days after surgery, on average)

Secondary Outcomes (1)

• Accuracy of differentiating benign from malignant lesions between SWEI techniques

  Pre-operative visit (within 24 hours before surgery, on average)

Study Arms (2)

MAC-SWEI, standard SWEI, ultrasound

Participants in this group will receive all three imaging techniques

Diagnostic Test: Ultrasound; Diagnostic Test: Shear wave elasticity imaging; Diagnostic Test: Multi-angle compound shear wave elasticity imaging

Standard SWEI, ultrasound

Participants in this group will receive two imaging techniques

Diagnostic Test: Ultrasound; Diagnostic Test: Shear wave elasticity imaging

Interventions

Ultrasound DIAGNOSTIC_TEST

All ultrasound images will be acquired by an in-house ultrasound technologist using a Verasonics Vantage (Verasonics Inc., Kirkland, Washington, USA) ultrasound system. During imaging, the technologist will position the Verasonics transducer, under b-mode guidance, in planes overlying the thyroid nodules approximating those obtained during previous clinical ultrasound scans.

MAC-SWEI, standard SWEI, ultrasound; Standard SWEI, ultrasound

Shear wave elasticity imaging DIAGNOSTIC_TEST

Shear wave elasticity imaging (SWEI) is obtained during the standard ultrasound session. The generation of shear wave images consists of two important steps called "pushing" and "tracking". First, in the "pushing" mode, a long focused ultrasound beam is transmitted to perturb tissue, generating ultrasonic shear waves in tissue that propagate perpendicular to the direction of pushing. In the "tracking" mode, shear wave propagation is observed and recorded. Because the speed of shear waves is a function of Young's modulus, these data reveal information about the stiffness of underlying biological tissue.

Also known as: SWEI

MAC-SWEI, standard SWEI, ultrasound; Standard SWEI, ultrasound

Multi-angle compound shear wave elasticity imaging DIAGNOSTIC_TEST

The multi-angle compound SWEI (MAC-SWEI) algorithm, which generates shear images based on multiple angled push beams, has the potential to generate more accurate shear wave images in the context of thyroid imaging. To assess the MAC-SWEI technique, shear wave images will be used to generate estimates of the relative stiffness of lesions via their normalized Young's modulus.

Also known as: MAC-SWEI

MAC-SWEI, standard SWEI, ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants will be recruited from patients of the Emory Healthcare system who are scheduled to have a thyroid biopsy, thyroidectomy, or cervical node biopsy.

You may qualify if:

• Age ≥ 18 years old
• Scheduled to undergo a thyroid biopsy, thyroidectomy, or cervical node biopsy

You may not qualify if:

• None

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory Univeristy Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Neoplasms; Thyroid Nodule

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Stanislav Emelianov, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Professor

Study Record Dates

• First Submitted: October 3, 2017
• First Posted: October 12, 2017
• Study Start: October 23, 2017
• Primary Completion: July 13, 2018
• Study Completion: July 13, 2018
• Last Updated: December 3, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)