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

Liver Tumors Clinical Trial

— Definity®  

Official title:

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

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

• Liver Neoplasms
• Liver Tumors

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