Ultrasound Elastography in Imaging Patients With Thyroid Nodules

NCT ID: NCT03174925

Last Updated: 2021-07-08

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-24

Study Completion Date

2019-02-13

Brief Summary

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

Detailed Description

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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.

Conditions

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Malignant Thyroid Gland Neoplasm Thyroid Gland Nodule

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Siemens Acuson S3000 ultrasound system
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Siemens Acuson S3000 ultrasound system

Intervention Type DEVICE

Shear Wave Elastography

Interventions

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Siemens Acuson S3000 ultrasound system

Shear Wave Elastography

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Aya Kamaya

Professor of Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Aya Kamaya

Role: PRINCIPAL_INVESTIGATOR

Stanford Cancer Institute

Locations

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Stanford University, School of Medicine

Palo Alto, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

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NCI-2017-00841

Identifier Type: REGISTRY

Identifier Source: secondary_id

END0020

Identifier Type: OTHER

Identifier Source: secondary_id

IRB-23634

Identifier Type: -

Identifier Source: org_study_id

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