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

NCT03106337 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2017-05-16

Study results available
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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

DEVICE

Shear-Wave Elastography

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

Sponsors & Collaborators

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Antonia E. Stephen, MD · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-01-31
Primary Completion
2012-04-30
Completion
2012-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03106337 on ClinicalTrials.gov