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



Status:Completed
Conditions:Liver Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:10/19/2013
Start Date:May 2008
End Date:May 2010
Contact:Susan Ellis, RN
Email:susan.ellis@louisville.edu
Phone:502-629-3384

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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.


The primary objective of this study is to demonstrate the safety of the use of
intra-operative ultrasound contrast (Definity®) administration. The secondary objective of
this study is to demonstrate the improved image quality and conspicuity of known liver
tumors using contrast enhancement.

Inclusion Criteria:

1. Undergoing a hepatic resection or hepatic ablation of pre-operative visualized liver
tumor:

2. ≥ 18 years of age

3. If female of child-bearing potential, negative pregnancy test within 14 days prior to
surgery

4. 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.

5. IRB-approved informed consent, signed by the subject or the subject's legally
authorized representative. ≥ 18 years of age

Exclusion Criteria:

1. Not a suitable candidate for operation
We found this trial at
2
sites
530 S Jackson St
Louisville, Kentucky 40202
502-562-3226
University of Louisville Hospital As the academic hospital at the heart of the Louisville Metro...
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Louisville, Kentucky 40207
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