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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00955097
Other study ID # Definity 08.0119
Secondary ID 08.0119
Status Terminated
Phase Phase 1
First received August 6, 2009
Last updated October 18, 2013
Start date May 2008
Est. completion date May 2010

Study information

Verified date October 2013
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Terminated
Enrollment 6
Est. completion date May 2010
Est. primary completion date June 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
Definity®
Definity® injections given both pre-ablation and post-ablation

Locations

Country Name City State
United States Norton Healthcare Louisville Kentucky
United States University of Louisville Hospital Louisville Kentucky

Sponsors (1)

Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary adverse events 6-weeks post surgery Yes
Primary identification of liver tumors intra-operative No
Secondary improved ablation of liver tumors 6-weeks post surgery No
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