Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound

Thyroid Nodules Clinical Trial

Official title:

Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01225016
• Other study ID #: UAB 1007
• Status: Withdrawn
• Phase: N/A
• First received: October 14, 2010
• Last updated: January 27, 2012
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: January 2012
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Thyroid Diseases
• Thyroid Nodule
• Thyroid Nodules

Intervention

Drug:
• Definity contrast agent
Thyroid ultrasound using contrast agent

Locations

Country	Name	City	State
United States	Universith of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
University of Alabama at Birmingham

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To estimate the accuracy (sensitivity and specificity) of the contrast enhanced ultrasound for characterization of thyroid nodules.		30 days	No