Ultrasound Elastography in Imaging Patients With Thyroid Nodules

NCT03174925 | Completed Results DMC FDA Device

• 3 other identifiers: IRB-23634NCI-2017-00841END0020
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial studies how well ultrasound elastography works in assessing the cancer status of potentially malignant thyroid nodules.

Conditions

Malignant Thyroid Gland Neoplasm; Thyroid Gland Nodule

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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.

Device: Siemens Acuson S3000 ultrasound system

Interventions

Siemens Acuson S3000 ultrasound system DEVICE

Shear Wave Elastography

Tissue Stiffness by Elastography

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presence of a thyroid nodule that is amenable to ultrasound guided fine needle aspiration

You may not qualify if:

• Patients who are unable to lie supine for a biopsy
• Pregnant patients

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Stanford University, School of Medicine

Palo Alto, California, 94304, United States

Location

MeSH Terms

Conditions

Thyroid Neoplasms; Thyroid Nodule

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Endocrine System Diseases; Thyroid Diseases

Results Point of Contact

• Title: Aya Kamaya, Professor of Radiology
• Organization: Stanford University Medical Center

kamaya@stanford.edu

650-725-1812

Study Officials

• Aya Kamaya

  Stanford Cancer Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Radiology

Model Details: Siemens Acuson S3000 ultrasound system

Study Record Dates

• First Submitted: May 18, 2017
• First Posted: June 5, 2017
• Study Start: January 24, 2014
• Primary Completion: February 13, 2018
• Study Completion: February 13, 2019
• Last Updated: July 8, 2021
• Results First Posted: July 8, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)