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

Thyroid Nodule Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03106337
• Other study ID #: 2007P001161
• Status: Completed
• Phase: N/A
• First received: April 25, 2014
• Last updated: April 3, 2017
• Start date: January 2010
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: March 2016
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed with a Follicular Neoplasm on fine needle aspiration biopsy

• Patients >18 years of age

Exclusion Criteria

Related Conditions & MeSH terms

• Follicular Neoplasm
• Neoplasms
• Thyroid Diseases
• Thyroid Nodule

Intervention

Device:
• Shear Wave Sonoelastography
Shear Wave Sonoelastography is performed on patients scheduled for partial/total thyroidectomy. Results are compared with pathology from surgical excision.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shear Wave Elastography Values in kiloPascals (kPa)	Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule.; We will compare mean elastography values of all benign lesions with mean values of all malignant lesions on histopathology obtained post surgery.	Baseline (Day 0).