Status:
TERMINATED
Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
Lead Sponsor:
University of Louisville
Conditions:
Liver Tumors
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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 t...
Eligibility Criteria
Inclusion
- 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
- 1\. Not a suitable candidate for operation
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT00955097
Start Date
May 1 2008
End Date
May 1 2010
Last Update
October 21 2013
Active Locations (2)
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1
Norton Healthcare
Louisville, Kentucky, United States, 40202
2
University of Louisville Hospital
Louisville, Kentucky, United States, 40202