Back to resultsCharacterization of Thyroid Nodules Using Contrast Enhanced Ultrasound
Primary Purpose
Thyroid Nodules
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Definity contrast agent
Sponsored by
About this trial
This is an interventional diagnostic trial for Thyroid Nodules
Eligibility Criteria
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
Sites / Locations
- Universith of Alabama at Birmingham
Outcomes
Primary Outcome Measures
To estimate the accuracy (sensitivity and specificity) of the contrast enhanced ultrasound for characterization of thyroid nodules.
Secondary Outcome Measures
Full Information
NCT ID
NCT01225016
First Posted
October 14, 2010
Last Updated
January 27, 2012
Sponsor
University of Alabama at Birmingham
1. Study Identification
Unique Protocol Identification Number
NCT01225016
Brief Title
Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound
Official Title
Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound
Study Type
Interventional
2. Study Status
Record Verification Date
January 2012
Overall Recruitment Status
Withdrawn
Why Stopped
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issues with ability to complete all procedures, it was decided that this study could not be carried out and therefore withdrawn.
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study will evaluate thyroid nodules using specialized ultrasound imaging methods.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodules
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Definity contrast agent
Intervention Description
Thyroid ultrasound using contrast agent
Primary Outcome Measure Information:
Title
To estimate the accuracy (sensitivity and specificity) of the contrast enhanced ultrasound for characterization of thyroid nodules.
Time Frame
30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn E Peters, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universith of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound
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