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 |
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
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