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Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01225016
Recruitment Status : Withdrawn (Due to lack of funding and issues with ability to complete all procedures, it was decided that this study could not be carried out and therefore withdrawn.)
First Posted : October 20, 2010
Last Update Posted : January 31, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study will evaluate thyroid nodules using specialized ultrasound imaging methods.

Condition or disease Intervention/treatment
Thyroid Nodules Drug: Definity contrast agent

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound
Study Start Date : October 2010
Primary Completion Date : December 2011
Study Completion Date : December 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Thyroid
U.S. FDA Resources

Arms and Interventions

Intervention Details:
    Drug: Definity contrast agent
    Thyroid ultrasound using contrast agent

Outcome Measures

Primary Outcome Measures :
  1. To estimate the accuracy (sensitivity and specificity) of the contrast enhanced ultrasound for characterization of thyroid nodules. [ Time Frame: 30 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01225016

United States, Alabama
Universith of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
Sponsors and Collaborators
University of Alabama at Birmingham
Principal Investigator: Glenn E Peters, MD University of Alabama at Birmingham
More Information

Responsible Party: Glenn Peters, MD, Professor of Surgery, University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01225016     History of Changes
Other Study ID Numbers: UAB 1007
First Posted: October 20, 2010    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Head and Neck Neoplasms