Back to resultsEvaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors (Definity®)
Primary Purpose
Liver Tumors
Status
Terminated
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Definity®
Sponsored by
About this trial
This is an interventional diagnostic trial for Liver Tumors focused on measuring Definity, liver tumors, intra operative contrast, liver cancer, hepatic tumors, identify liver tumors, surgery liver tumors, Patients with known hepatic tumors
Eligibility Criteria
Inclusion Criteria:
- Undergoing a hepatic resection or hepatic ablation of pre-operative visualized liver tumor:
- ≥ 18 years of age
- If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery
- 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.
- 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
Sites / Locations
- Norton Healthcare
- University of Louisville Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Definity Contrast Dye
Arm Description
During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors
Outcomes
Primary Outcome Measures
adverse events
identification of liver tumors
Secondary Outcome Measures
improved ablation of liver tumors
Full Information
NCT ID
NCT00955097
First Posted
August 6, 2009
Last Updated
October 18, 2013
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT00955097
Brief Title
Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
Acronym
Definity®
Official Title
Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
Study Type
Interventional
2. Study Status
Record Verification Date
October 2013
Overall Recruitment Status
Terminated
Why Stopped
No funding for this study
Study Start Date
May 2008 (undefined)
Primary Completion Date
June 2009 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Tumors
Keywords
Definity, liver tumors, intra operative contrast, liver cancer, hepatic tumors, identify liver tumors, surgery liver tumors, Patients with known hepatic tumors
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Definity Contrast Dye
Arm Type
Experimental
Arm Description
During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors
Intervention Type
Drug
Intervention Name(s)
Definity®
Intervention Description
Definity® injections given both pre-ablation and post-ablation
Primary Outcome Measure Information:
Title
adverse events
Time Frame
6-weeks post surgery
Title
identification of liver tumors
Time Frame
intra-operative
Secondary Outcome Measure Information:
Title
improved ablation of liver tumors
Time Frame
6-weeks post surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Undergoing a hepatic resection or hepatic ablation of pre-operative visualized liver tumor:
≥ 18 years of age
If female of child-bearing potential, negative pregnancy test within 14 days prior to surgery
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.
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Martin, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
Norton Healthcare
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors
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