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

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

This study is currently recruiting participants.

Verified by University of Louisville, August 2009

First Received: August 6, 2009 No Changes Posted

Sponsored by:	University of Louisville
Information provided by:	University of Louisville
ClinicalTrials.gov Identifier:	NCT00955097

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 0

Study Type:	Interventional
Study Design:	Diagnostic, Open Label, Single Group Assignment, Safety Study
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: Octafluoropropane

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 ]

Estimated Enrollment:	20
Study Start Date:	May 2008
Estimated Study Completion Date:	May 2010
Estimated Primary Completion Date:	June 2009 (Final data collection date for primary outcome measure)

Intervention Details:

Definity® injections given both pre-ablation and post-ablation

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00955097

Contacts

Contact: Susan Ellis, RN

502-629-3384

susan.ellis@louisville.edu

Locations

United States, Kentucky
Norton Healthcare	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Susan Ellis, RN 502-629-3384 susan.ellis@louisville.edu
Principal Investigator: Robert Martin, MD
University of Louisville Hospital	Recruiting
Louisville, Kentucky, United States, 40202
Contact: Susan Ellis, RN 502-629-3384 susan.ellis@louisville.edu
Principal Investigator: Robert Martin, MD

Sponsors and Collaborators

University of Louisville

Investigators

Principal Investigator:

Robert Martin, MD

University of Louisville

More Information

No publications provided

Responsible Party:	University of Louisville ( Dr. Robert C. G. Martin )
Study ID Numbers:	Definity 08.0119, 08.0119
Study First Received:	August 6, 2009
Last Updated:	August 6, 2009
ClinicalTrials.gov Identifier:	NCT00955097 History of Changes
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

Study placed in the following topic categories:

Liver Neoplasms
Liver Diseases
Digestive System Diseases
Digestive System Neoplasms
Gastrointestinal Neoplasms

Additional relevant MeSH terms:

Liver Neoplasms
Liver Diseases
Neoplasms

Digestive System Diseases
Neoplasms by Site
Digestive System Neoplasms

ClinicalTrials.gov processed this record on September 11, 2009