Trial Outcomes & Findings for Ultrasound Elastography in Imaging Patients With Thyroid Nodules (NCT NCT03174925)

Last Updated: 2021-07-08

Results Overview

Potentially cancerous thyroid nodules will be assessed elastographically, and cancer status will be determined from a fine needle aspiration biopsy results or the surgically excised nodule. The outcome will be reported as median tissue stiffness with standard deviation for nodules that were determined non-cancerous (benign), cancerous, or indeterminate.

Recruitment status

COMPLETED

Study phase

Target enrollment

55 participants

Primary outcome timeframe

1 week

Results posted on

2021-07-08

Participant Flow

Participant milestones

Participant milestones
Measure	Tissue Stiffness by Elastography Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status. Siemens Acuson S3000 ultrasound system: Shear Wave Elastography
Overall Study STARTED	55
Overall Study COMPLETED	52
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Reasons for withdrawal
Measure	Tissue Stiffness by Elastography Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status. Siemens Acuson S3000 ultrasound system: Shear Wave Elastography
Overall Study Elastographic images not retrievable	2
Overall Study Elastography image not interpretable	1

Baseline Characteristics

Ultrasound Elastography in Imaging Patients With Thyroid Nodules

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Tissue Stiffness by Elastography n=55 Participants Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status. Siemens Acuson S3000 ultrasound system: Shear Wave Elastography
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	38 Participants n=5 Participants
Age, Categorical >=65 years	17 Participants n=5 Participants
Age, Continuous	56.6 years STANDARD_DEVIATION 13.8 • n=5 Participants
Sex: Female, Male Female	43 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	49 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	11 Participants n=5 Participants
Region of Enrollment United States	55 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 week

Population: An individual participant could contribute multiple nodules.

Outcome measures

Outcome measures
Measure	Tissue Stiffness by Elastography n=66 Thyroid nodules Potentially cancerous thyroid nodules were assessed by elastrography, then a fine needle biopsy specimen or the surgically-excised nodule was assessed pathologically to determine cancer status. Siemens Acuson S3000 ultrasound system: Shear Wave Elastography
Stiffness of Thyroid Nodules as Measured by Elastography Pathologically Noncancerous Thyroid Nodules	2.7 meters/second Standard Deviation 0.7
Stiffness of Thyroid Nodules as Measured by Elastography Pathologically Cancerous Thyroid Nodules	3.8 meters/second Standard Deviation 0.7
Stiffness of Thyroid Nodules as Measured by Elastography Pathologically Indeterminate Thyroid Nodules	2.7 meters/second Standard Deviation 1.1

Adverse Events

Tissue Stiffness by 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

Aya Kamaya, Professor of Radiology

Stanford University Medical Center

Phone: 650-725-1812

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place