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

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

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