Thyroid Ultrasound Elasticity (TrUE) Imaging

Completed

• Conditions: Cancer, Thyroid
• Interventions: Diagnostic Test: Ultrasound; Diagnostic Test: Shear wave elasticity imaging; Diagnostic Test: Multi-angle compound shear wave elasticity imaging

• Registration Number: NCT03307694
• Lead Sponsor: Emory University

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.

Detailed Description

Thyroid ultrasound is a first-line procedure to assess patients with thyroid nodules. Unfortunately, standard ultrasound has low sensitivity, and thus low positive predictive value, for malignancy and many patients with thyroid nodules are referred for additional imaging studies or biopsy. Shear wave elasticity imaging (SWEI) is a non-invasive ultrasound technology that allows clinicians to assess the stiffness of tissues. In many solid tumors, increased stiffness is highly specific for underlying malignancy, and preliminary studies have shown this to be true for thyroid malignancies. Both standard sonography and SWEI can be performed on the same ultrasound equipment and within the same imaging session. Therefore, integrating SWEI into standard thyroid diagnostic workflow is a logical approach towards improving the positive predictive value of these first-line sonographic studies. Other studies have demonstrated the ability of SWEI techniques to differentiate benign from malignant thyroid nodules. However, shear wave techniques still need to overcome challenges before they can be successfully integrated into the clinical paradigm. These techniques still struggle to accurately classify follicular carcinomas and few have been validated in patients with multiple thyroid lesions, a scenario which is clinically common. The researchers believe that a 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 this end, this study will perform proof-of-concept studies of MAC-SWEI in thyroid patients undergoing standard ultrasound scans and compare the results of shear wave images to results from corresponding pathology.

Study participants will undergo a single SWEI session within their normally-scheduled preadmission testing during which both standard b-mode and shear images of the thyroid nodule(s) will be acquired. The 36 patients will be randomized to receive MAC-SWEI, standard SWEI, and ultrasound, or only standard SWEI and ultrasound.

Study Timeline

• Study First Submitted: 2017-10-03
• Study First Submitted QC: 2017-10-06
• Study First Posted: 2017-10-12
• Study Start: 2017-10-23
• Primary Completion: 2018-07-13
• Study Completion: 2018-07-13
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-01
• Last Update Posted: 2019-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

Inclusion Criteria

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

Read More

Exclusion Criteria

• None

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Standard SWEI, ultrasound	Ultrasound	Participants in this group will receive two imaging techniques
Standard SWEI, ultrasound	Shear wave elasticity imaging	Participants in this group will receive two imaging techniques
MAC-SWEI, standard SWEI, ultrasound	Ultrasound	Participants in this group will receive all three imaging techniques
MAC-SWEI, standard SWEI, ultrasound	Shear wave elasticity imaging	Participants in this group will receive all three imaging techniques
MAC-SWEI, standard SWEI, ultrasound	Multi-angle compound shear wave elasticity imaging	Participants in this group will receive all three imaging techniques

Primary Outcome Measures

Name	Time	Method
Determination of Malignancy by SWEI Imaging	Pre-operative visit (within 24 hours before surgery, on average)	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.
Determination of Malignancy by Pathological Proof	Post-surgery (within 10 days after surgery, on average)	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.

Secondary Outcome Measures

Name	Time	Method
Accuracy of differentiating benign from malignant lesions between SWEI techniques	Pre-operative visit (within 24 hours before surgery, on average)	The ability of MAC-SWEI to differentiate benign from malignant lesions will be compared to the ability of standard SWEI to make this differentiation.

Trial Locations

Locations (1)

Emory Univeristy Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States