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Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors


Phase 0
18 Years
N/A
Open (Enrolling)
Both
Liver Tumors

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Trial Information

Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors


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.


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

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

adverse events

Outcome Time Frame:

6-weeks post surgery

Safety Issue:

Yes

Principal Investigator

Robert Martin, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Louisville

Authority:

United States: Food and Drug Administration

Study ID:

Definity 08.0119

NCT ID:

NCT00955097

Start Date:

May 2008

Completion Date:

May 2010

Related Keywords:

  • Liver Tumors
  • Definity
  • liver tumors
  • intra operative contrast
  • liver cancer
  • hepatic tumors
  • identify liver tumors
  • surgery liver tumors
  • Patients with known hepatic tumors
  • Liver Neoplasms

Name

Location
University of Louisville Hospital Louisville, Kentucky  40202
Norton Healthcare Louisville, Kentucky  40202