Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors

Stopped early · Phase 1

Conditions studied: Liver Tumors

In brief

The primary purpose of this study is to demonstrate the safety and effectiveness of using an intra-operative ultrasound contrast agent(Definity®) for the identification of known liver tumors.

Key facts

Study ID

NCT00955097

Run by

University of Louisville

People needed

6

Starts

2008-05-01

Expected to finish

2010-05-01

Last updated by the study team

2013-10-21

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Undergoing a hepatic resection or hepatic ablation of pre-operative visualized liver tumor:
• ≥ 18 years of age
• If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery
• If subject is a sexually active male or a sexually active female of child-bearing potential, subject agrees to use a medically accepted form of contraception from the time of enrollment to completion of all follow-up study visits.
• IRB-approved informed consent, signed by the subject or the subject's legally authorized representative. ≥ 18 years of age

You may not qualify if…

• Not a suitable candidate for operation

Where it is running

• Norton Healthcare — Louisville, Kentucky, United States
• University of Louisville Hospital — Louisville, Kentucky, United States

Full record on ClinicalTrials.gov

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