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

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ClinicalTrials.gov Identifier: NCT00955097
Recruitment Status : Terminated (No funding for this study)
First Posted : August 7, 2009
Last Update Posted : October 21, 2013
Sponsor:
Information provided by (Responsible Party):
Robert C. Martin, University of Louisville

Study Description
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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 or disease Intervention/treatment Phase
Liver Tumors Drug: Definity® Phase 1

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
Study Start Date : May 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Perflutren
U.S. FDA Resources

Arms and Interventions
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Arm Intervention/treatment
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


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

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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: August 7, 2009    Key Record Dates
Last Update Posted: October 21, 2013
Last Verified: October 2013

Keywords provided by Robert C. Martin, 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