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
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 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
Neoplasms
Digestive System Diseases
Digestive System Neoplasms
Liver Diseases
Neoplasms by Site
Definity
Perflutren
Contrast Media
Diagnostic Uses of Chemicals
Pharmacologic Actions

ClinicalTrials.gov processed this record on October 22, 2014