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N/A N=35 Diagnostic

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

Thyroid Nodule · Follicular Neoplasm

Enrolled (actual)
35
Serious AEs
0.0%
Results posted
May 2017
Primary outcome: Primary: Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) — 17.50; 31.03; 23.64; 32.14 kPa

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
Shear-Wave Elastography (Device)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Massachusetts General Hospital
Primary completion
Apr 2012

Outcome Measures

OutcomeResultp-value
PRIMARY
Shear-Wave Elastography (SWE) Values in kiloPascals (kPa)
17.50; 31.03; 23.64; 32.14; 17.89; 33.80

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.

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • None
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03106337). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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