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

This study has been terminated.
(No funding for this study)
Sponsor:
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville
ClinicalTrials.gov Identifier:
NCT00955097
First received: August 6, 2009
Last updated: October 18, 2013
Last verified: October 2013
  Purpose

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: Endpoint Classification: Safety Study
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 ] [ Designated as safety issue: Yes ]
  • identification of liver tumors [ Time Frame: intra-operative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • improved ablation of liver tumors [ Time Frame: 6-weeks post surgery ] [ Designated as safety issue: No ]

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
Other Name: Definity®

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00955097

Locations
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
Investigators
Principal Investigator: Robert Martin, MD University of Louisville
  More Information

No publications provided

Responsible Party: Robert C. Martin, MD, University of Louisville
ClinicalTrials.gov Identifier: NCT00955097     History of Changes
Other Study ID Numbers: Definity 08.0119, 08.0119
Study First Received: August 6, 2009
Last Updated: October 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Louisville:
Definity
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
Neoplasms
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on April 14, 2014