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

History of Changes

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:

MedlinePlus related topics: Cancer Liver Cancer Ultrasound

Drug Information available for: Perflutren

Genetic and Rare Diseases Information Center resources: Liver Cancer

U.S. FDA Resources

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:

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

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 February 25, 2015

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