NCT03106337

Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid

A Multivariate Analysis of Factors Predictive of Carcinoma in Follicular Neoplasms of the Thyroid Gland

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

As many as 70-85% subjects diagnosed with a follicular lesion on biopsy and undergoing surgery will have benign lesions verified by histopathology after surgery. Currently there is no method of pre-operatively diagnosing benign follicular lesions, as a result these subjects will have had surgery for diagnosis of a benign lesion. The aim of this study is to see whether shear-wave elastography, a new ultrasound technology can help pre-operatively diagnose benign follicular lesions. If successful, a lot of patients will not need surgery for the diagnosis of a benign lesion. The main goal of this study will be to evaluate the diagnostic accuracy of a new ultrasound technology, shear-wave elastography (SWE), for the diagnosis of malignancy in follicular lesions. Participants who have been diagnosed with a follicular lesion on thyroid biopsy and are scheduled for thyroid surgery will be eligible to participate. All participants will undergo a detailed ultrasound examination prior to their surgery. The results of the ultrasound will be compared with histopathology after surgery to test the diagnostic accuracy of SWE.

Conditions

• Thyroid Nodule
• Follicular Neoplasm

Interventions

Type	Name	Description
DEVICE	Shear-Wave Elastography	Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.

Timeline

• Start date: 2010-01-01
• Primary completion: 2012-04-01
• Completion: 2012-04-01
• First posted: 2017-04-10
• Last updated: 2017-05-16
• Results posted: 2017-05-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study