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This study has been withdrawn prior to enrollment.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issues with ability to complete all procedures, it was decided that this study could not be carried out and therefore withdrawn.)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
  Purpose

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


Condition Intervention
Thyroid Nodules
Drug: Definity contrast agent

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Characterization of Thyroid Nodules Using Contrast Enhanced Ultrasound

Resource links provided by NLM:


Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • 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 ]

Enrollment: 0
Study Start Date: October 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Definity contrast agent
    Thyroid ultrasound using contrast agent
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01225016

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

No publications provided

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
Study First Received: October 14, 2010
Last Updated: January 27, 2012
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Additional relevant MeSH terms:
Thyroid Diseases
Thyroid Nodule
Endocrine System Diseases
Thyroid Neoplasms
Endocrine Gland Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Contrast Media
Definity
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 21, 2014