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

NCT ID: NCT00955097

Last Updated: 2013-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-05-31

Brief Summary

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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

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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.

Conditions

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Liver Tumors

Keywords

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Definity liver tumors intra operative contrast liver cancer hepatic tumors identify liver tumors surgery liver tumors Patients with known hepatic tumors

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Definity Contrast Dye

During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors

Group Type EXPERIMENTAL

Definity®

Intervention Type DRUG

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

Interventions

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Definity®

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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Robert C. Martin

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Robert Martin, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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Norton Healthcare

Louisville, Kentucky, United States

Site Status

University of Louisville Hospital

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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08.0119

Identifier Type: -

Identifier Source: secondary_id

Definity 08.0119

Identifier Type: -

Identifier Source: org_study_id