Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

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

This study has been terminated.
(No funding for this study)
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville Identifier:
First received: August 6, 2009
Last updated: October 18, 2013
Last verified: October 2013
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.

Condition Intervention Phase
Liver Tumors
Drug: Definity®
Phase 1

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors

Resource links provided by NLM:

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • adverse events [ Time Frame: 6-weeks post surgery ]
  • identification of liver tumors [ Time Frame: intra-operative ]

Secondary Outcome Measures:
  • improved ablation of liver tumors [ Time Frame: 6-weeks post surgery ]

Enrollment: 6
Study Start Date: May 2008
Study Completion Date: May 2010
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Definity Contrast Dye
During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors
Drug: Definity®
Definity® injections given both pre-ablation and post-ablation

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.

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00955097

United States, Kentucky
Norton Healthcare
Louisville, Kentucky, United States, 40202
University of Louisville Hospital
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
Principal Investigator: Robert Martin, MD University of Louisville
  More Information

Responsible Party: Robert C. Martin, MD, University of Louisville Identifier: NCT00955097     History of Changes
Other Study ID Numbers: Definity 08.0119
Study First Received: August 6, 2009
Last Updated: October 18, 2013

Keywords provided by University of Louisville:
liver tumors
intra operative contrast
liver cancer
hepatic tumors
identify liver tumors
surgery liver tumors
Patients with known hepatic tumors

Additional relevant MeSH terms:
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases processed this record on May 22, 2017