Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors (Definity®)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Louisville.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00955097
First received: August 6, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted

August 6, 2009
August 6, 2009
May 2008
June 2009   (final data collection date for primary outcome measure)
  • adverse events [ Time Frame: 6-weeks post surgery ] [ Designated as safety issue: Yes ]
  • identification of liver tumors [ Time Frame: intra-operative ] [ Designated as safety issue: No ]
Same as current
No Changes Posted
improved ablation of liver tumors [ Time Frame: 6-weeks post surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors

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.

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.

Interventional
Phase 0
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Liver Tumors
Drug: Definity®
Definity® injections given both pre-ablation and post-ablation
Other Name: Definity®
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
May 2010
June 2009   (final data collection date for primary outcome measure)

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

Both
18 Years and older
No
Contact: Susan Ellis, RN 502-629-3384 susan.ellis@louisville.edu
United States
 
NCT00955097
Definity 08.0119, 08.0119
No
Dr. Robert C. G. Martin, University of Louisville
University of Louisville
Not Provided
Principal Investigator: Robert Martin, MD University of Louisville
University of Louisville
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP