N/A
N=35
Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid
Thyroid Nodule · Follicular Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT03106337 ↗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
| Outcome | Result | p-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
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.