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

• Status: Terminated
• Trial end date: 2010-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Louisville

Criteria

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