NCT00955097

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started May 2008

Typical duration for phase_1

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 7, 2009

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

October 21, 2013

Status Verified

October 1, 2013

Enrollment Period

1.1 years

First QC Date

August 6, 2009

Last Update Submit

October 18, 2013

Conditions

Liver Tumors

Keywords

Definityliver tumorsintra operative contrastliver cancerhepatic tumorsidentify liver tumorssurgery liver tumorsPatients with known hepatic tumors

Outcome Measures

Primary Outcomes (2)

  • adverse events

    6-weeks post surgery

  • identification of liver tumors

    intra-operative

Secondary Outcomes (1)

  • improved ablation of liver tumors

    6-weeks post surgery

Study Arms (1)

Definity Contrast Dye

EXPERIMENTAL

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

Drug: Definity®

Interventions

Definity®DRUG

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

Definity Contrast Dye

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • \. Not a suitable candidate for operation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Norton Healthcare

Louisville, Kentucky, 40202, United States

Location

University of Louisville Hospital

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Carcinoma, HepatocellularLiver Neoplasms

Interventions

perflutren

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • Robert Martin, MD

    University of Louisville

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

August 6, 2009

First Posted

August 7, 2009

Study Start

May 1, 2008

Primary Completion

June 1, 2009

Study Completion

May 1, 2010

Last Updated

October 21, 2013

Record last verified: 2013-10

Locations

US(2)