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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01225016
Other study ID # UAB 1007
Secondary ID
Status Withdrawn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Status Withdrawn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


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
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