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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2017-00841 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| END0020 | Other Identifier | OnCore |
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This clinical trial studies how well ultrasound elastography works in assessing the cancer status of potentially malignant thyroid nodules.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tissue Stiffness by Elastography | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Siemens Acuson S3000 ultrasound system | Device | Shear Wave Elastography |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aya Kamaya | Stanford Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University, School of Medicine | Palo Alto | California | 94304 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | An individual participant could contribute multiple nodules. | Posted | Median | Standard Deviation | meters/second | 1 week | Thyroid nodules | Thyroid nodules |
|
Day of procedure
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Aya Kamaya, Professor of Radiology | Stanford University Medical Center | 650-725-1812 | kamaya@stanford.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Apr 3, 2017 | Jun 16, 2021 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| D016606 | Thyroid Nodule |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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Siemens Acuson S3000 ultrasound system
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| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| 0 |
| 55 |
| 0 |
| 55 |
| 0 |
| 55 |
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| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |