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

Not Applicable

Completed

• Conditions: Thyroid Nodule; Follicular Neoplasm
• Interventions: Device: Shear-Wave Elastography

• Registration Number: NCT03106337
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01
• Primary Completion: 2012-04
• Study Completion: 2012-04
• Study First Submitted: 2014-04-25
• Status Verified: 2017-04
• Study First Submitted QC: 2017-04-03
• Study First Posted: 2017-04-10
• Results First Submitted: 2017-04-13
• Results First Submitted QC: 2017-04-13
• Last Update Submitted: 2017-04-13
• Results First Posted: 2017-05-16
• Last Update Posted: 2017-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

Inclusion Criteria

• Patients diagnosed with a Follicular Neoplasm on fine needle aspiration biopsy
• Patients >18 years of age

Exclusion Criteria

• None

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Shear-Wave Elastography (SWE) Values in kiloPascals (kPa)	Baseline (Day 0)	Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States