Liver Tumors
Conditions
Keywords
Definity, liver tumors, intra operative contrast, liver cancer, hepatic tumors, identify liver tumors, surgery liver tumors, Patients with known hepatic tumors
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.
Interventions
DRUGDefinity®
Definity® injections given both pre-ablation and post-ablation
Sponsors
University of Louisville
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events | 6-weeks post surgery |
| identification of liver tumors | intra-operative |
Secondary
| Measure | Time frame |
|---|---|
| improved ablation of liver tumors | 6-weeks post surgery |
Countries
United States
Outcome results
None listed