Malignant Thyroid Gland Neoplasm, Thyroid Gland Nodule
Conditions
Brief summary
This clinical trial studies how well ultrasound elastography works in assessing the cancer status of potentially malignant thyroid nodules.
Detailed description
PRIMARY OBJECTIVES: Determine the utility of ultrasound elastography in evaluation of thyroid nodules being evaluated for the presence of cancer. Elastography measures the passages of ultrasound shear waves through tissue to gauge the stiffness and compressibility of the tissue, collectively tissue stiffness, and may be a better way to image thyroid nodules. Tissue stiffness is a physiological parameter that is being evaluated for differences between non-cancerous (benign) and cancerous thyroid nodules. Participants will undergo elastography over the 10 minutes prior to either fine needle aspiration of a biopsy specimen or surgical resection of the thyroid nodule. Tissue specimens from the biopsy specimen or surgical resection will be assessed pathologically to determine actual cancer status.
Interventions
DEVICESiemens Acuson S3000 ultrasound system
Shear Wave Elastography
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Siemens Acuson S3000 ultrasound system
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Presence of a thyroid nodule that is amenable to ultrasound guided fine needle aspiration
Exclusion criteria
* Patients who are unable to lie supine for a biopsy * Pregnant patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Stiffness of Thyroid Nodules as Measured by Elastography | 1 week | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 55 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Elastographic images not retrievable | 2 |
| Overall Study | Elastography image not interpretable | 1 |
Baseline characteristics
| Characteristic | Tissue Stiffness by Elastography |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 17 Participants |
| Age, Categorical Between 18 and 65 years | 38 Participants |
| Age, Continuous | 56.6 years STANDARD_DEVIATION 13.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 4 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 49 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 11 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 11 Participants |
| Race (NIH/OMB) White | 30 Participants |
| Region of Enrollment United States | 55 Participants |
| Sex: Female, Male Female | 43 Participants |
| Sex: Female, Male Male | 12 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 55 |
| other Total, other adverse events | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 |
Outcome results
Primary
Stiffness of Thyroid Nodules as Measured by Elastography
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.
Time frame: 1 week
Population: An individual participant could contribute multiple nodules.
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Tissue Stiffness by Elastography | Stiffness of Thyroid Nodules as Measured by Elastography | Pathologically Noncancerous Thyroid Nodules | 2.7 meters/second | Standard Deviation 0.7 |
| Tissue Stiffness by Elastography | Stiffness of Thyroid Nodules as Measured by Elastography | Pathologically Cancerous Thyroid Nodules | 3.8 meters/second | Standard Deviation 0.7 |
| Tissue Stiffness by Elastography | Stiffness of Thyroid Nodules as Measured by Elastography | Pathologically Indeterminate Thyroid Nodules | 2.7 meters/second | Standard Deviation 1.1 |