CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Shear-Wave Elastographydevice
Likely dose
Not stated in record
Key inclusion· 2
  • Diagnosis of Follicular Neoplasm on fine needle aspiration biopsy
  • Age >18 years
Key exclusion· 0

None specified.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03106337
NCT03106337N/ACompleted

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

Massachusetts General Hospital·interventional·Posted Apr 10, 2017·Updated May 16, 2017

In Brief

A clinical study evaluating Shear-Wave Elastography for Thyroid Nodule and Follicular Neoplasm. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 10, 2017
Enrollment StartJan 1, 2010
Primary CompletionApr 1, 2012
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.2 years ago

Interventions

Shear-Wave Elastographydevice

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