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

Overview

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.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Diagnostic
    • Masking: None (Open Label)
  • Study Primary Completion Date: June 2009

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

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

Arms, Groups and Cohorts

  • Experimental: Definity Contrast Dye
    • During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors

Clinical Trial Outcome Measures

Primary Measures

  • adverse events
    • Time Frame: 6-weeks post surgery
  • identification of liver tumors
    • Time Frame: intra-operative

Secondary Measures

  • improved ablation of liver tumors
    • Time Frame: 6-weeks post surgery

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • University of Louisville
  • Provider of Information About this Clinical Study
    • Principal Investigator: Robert C. Martin, MD – University of Louisville
  • Overall Official(s)
    • Robert Martin, MD, Principal Investigator, University of Louisville

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