Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
Overview
- Phase
- Phase 1
- Intervention
- Definity®
- Conditions
- Liver Tumors
- Sponsor
- University of Louisville
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- adverse events
- Status
- Terminated
- Last Updated
- 12 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Robert C. Martin
MD
University of Louisville
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •Not a suitable candidate for operation
Arms & Interventions
Definity Contrast Dye
During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors
Intervention: Definity®
Outcomes
Primary Outcomes
adverse events
Time Frame: 6-weeks post surgery
identification of liver tumors
Time Frame: intra-operative
Secondary Outcomes
- improved ablation of liver tumors(6-weeks post surgery)