Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound

This study has been withdrawn prior to enrollment.

(Due to lack of funding and issues with ability to complete all procedures, it was decided that this study could not be carried out and therefore withdrawn.)

Sponsor:

Information provided by (Responsible Party):

Glenn Peters, MD, University of Alabama at Birmingham

ClinicalTrials.gov Identifier:

NCT01225016

First received: October 14, 2010

Last updated: January 27, 2012

Last verified: January 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 14, 2010

Last Updated Date

January 27, 2012

Start Date ^ICMJE

October 2010

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

To estimate the accuracy (sensitivity and specificity) of the contrast enhanced ultrasound for characterization of thyroid nodules. [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01225016 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound

Official Title ^ICMJE

Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound

Brief Summary

This study will evaluate thyroid nodules using specialized ultrasound imaging methods.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic

Condition ^ICMJE

Thyroid Nodules

Intervention ^ICMJE

Drug: Definity contrast agent

Thyroid ultrasound using contrast agent

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Withdrawn

Enrollment ^ICMJE

Completion Date

December 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

1. Patients diagnosed with a thyroid nodule 2. Age greater than or equal to 19 years of age 3. Patients must sign informed consent

Exclusion Criteria:

1. Women who are pregnant or nursing 2. Patients with pulmonary hypertension, unstable cardiopulmonary condition,or right to left shunt 3. Hypersensitivity to perfluten 4. Psychological condition that renders the patient unable to understand the informed consent

Gender

Both

Ages

19 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01225016

Other Study ID Numbers ^ICMJE

UAB 1007

Has Data Monitoring Committee

Yes

Responsible Party

Glenn Peters, MD, University of Alabama at Birmingham

Study Sponsor ^ICMJE

University of Alabama at Birmingham

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Glenn E Peters, MD

University of Alabama at Birmingham

Information Provided By

University of Alabama at Birmingham

Verification Date

January 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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