Trial Outcomes & Findings for Diagnostic Accuracy of Shear-Wave Elastography for the Preoperative Risk Stratification of Follicular Lesions of the Thyroid (NCT NCT03106337)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

Baseline (Day 0)

Results posted on

2017-05-16

Participant Flow

Participant milestones

Participant milestones
Measure	Shear-Wave Elastography Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
Overall Study STARTED	35
Overall Study COMPLETED	35
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Shear-Wave Elastography n=35 Participants Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision.
Age, Continuous	55 years STANDARD_DEVIATION 16.1 • n=5 Participants
Sex: Female, Male Female	23 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	35 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline (Day 0)

Population: All enrolled participants.

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.

Outcome measures

Outcome measures
Measure	Shear-Wave Elastography, Benign Lesions n=24 Participants Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort includes all participants with benign lesions.	Shear-Wave Elastography, Malignant Lesions n=11 Participants Shear-Wave Elastography was performed on patients scheduled for partial/total thyroidectomy. Results were compared with pathology from surgical excision. This cohort Includes all participants with malignant lesions.
Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) Sagittal Plane	23.64 kPa Standard Deviation 14.86	32.14 kPa Standard Deviation 11.98
Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) Transverse Plane	17.50 kPa Standard Deviation 7.65	31.03 kPa Standard Deviation 13.54
Shear-Wave Elastography (SWE) Values in kiloPascals (kPa) Transverse Plane with Nodule in the Center	17.89 kPa Standard Deviation 9.1	33.80 kPa Standard Deviation 12.50

Adverse Events

Shear-Wave Elastography

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Antonia Stephen, MD

Massachusetts General Hospital

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place