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

Phase 1

Terminated

• Conditions: Liver Tumors
• Interventions: Drug: Definity®

• Registration Number: NCT00955097
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study Start: 2008-05
• Primary Completion: 2009-06
• Study First Submitted: 2009-08-06
• Study First Submitted QC: 2009-08-06
• Study First Posted: 2009-08-07
• Study Completion: 2010-05
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-18
• Last Update Posted: 2013-10-21

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 6

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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Definity Contrast Dye	Definity®	During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors

Primary Outcome Measures

Name	Time	Method
adverse events	6-weeks post surgery
identification of liver tumors	intra-operative

Secondary Outcome Measures

Name	Time	Method
improved ablation of liver tumors	6-weeks post surgery

Trial Locations

Locations (2)

Norton Healthcare; 🇺🇸 Louisville, Kentucky, United States

University of Louisville Hospital; 🇺🇸 Louisville, Kentucky, United States