Ultrasound Elastography in Imaging Patients With Thyroid Nodules
Primary Purpose
Malignant Thyroid Gland Neoplasm, Thyroid Gland Nodule
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Siemens Acuson S3000 ultrasound system
Sponsored by
About this trial
This is an interventional diagnostic trial for Malignant Thyroid Gland Neoplasm
Eligibility Criteria
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
Sites / Locations
- Stanford University, School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tissue Stiffness by Elastography
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03174925
Brief Title
Ultrasound Elastography in Imaging Patients With Thyroid Nodules
Official Title
Elastography in Thyroid Nodule Evaluation
Study Type
Interventional
2. Study Status
Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 24, 2014 (Actual)
Primary Completion Date
February 13, 2018 (Actual)
Study Completion Date
February 13, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malignant Thyroid Gland Neoplasm, Thyroid Gland Nodule
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Siemens Acuson S3000 ultrasound system
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tissue Stiffness by Elastography
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Siemens Acuson S3000 ultrasound system
Intervention Description
Shear Wave Elastography
Primary Outcome Measure Information:
Title
Stiffness of Thyroid Nodules as Measured by Elastography
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Aya Kamaya
Organizational Affiliation
Stanford Cancer Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University, School of Medicine
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Ultrasound Elastography in Imaging Patients With Thyroid Nodules
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