An interventional study of Shear-Wave Elastography in Thyroid Nodule and Follicular Neoplasm, sponsored by Massachusetts General Hospital. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-05-16.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Diagnostic
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.
203 studies on the registry are indexed under Thyroid Nodule; 57 are open to participants now.
This study's enrollment of 35 is below the median of 80 across 120 interventional studies indexed under Thyroid Nodule.
Browse Thyroid Nodule studies →Massachusetts General Hospital is the lead sponsor of 2,582 studies on the registry; 451 are open to participants now.
Of its 221 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
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Exclusion Criteria
Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
Device: Shear-Wave Elastography
Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
Also known as: Supersonic Aixplorer
Shear-Wave Elastography (SWE) 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. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery.
Time frame: Baseline (Day 0)
| Milestone | Shear-Wave Elastography |
|---|---|
| Started | 35 |
| Completed | 35 |
| Not completed | 0 |
Elastography provides a quantitative score of thyroid nodule stiffness that is expected to correlate with the biological nature of the nodule. Mean SWE values, in three planes: traverse plane, sagittal plane and transverse plane with nodule in the center, of all benign lesions were compared with mean SWE values of all malignant lesions on histopathology obtained post surgery.
| kPa | Shear-Wave Elastography, Benign Lesions | Shear-Wave Elastography, Malignant Lesions |
|---|---|---|
| Transverse Plane | 17.50 ± 7.65 | 31.03 ± 13.54 |
| Sagittal Plane | 23.64 ± 14.86 | 32.14 ± 11.98 |
| Transverse Plane with Nodule in the Center | 17.89 ± 9.1 | 33.80 ± 12.50 |
Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Shear-Wave Elastography | — | 0/35 (0%) | 0/35 (0%) |
All enrolled participants.
| Age, Continuous(years) | Shear-Wave Elastography |
|---|---|
| Mean | 55 ± 16.1 |
| Sex: Female, Male(Participants) | Shear-Wave Elastography |
|---|---|
| Female | 23 |
| Male | 12 |
| Region of Enrollment(participants) | Shear-Wave Elastography |
|---|---|
| United States | 35 |
Plan to share: No
This study is completed, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.
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