Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors (Definity®)
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ClinicalTrials.gov Identifier: NCT00955097 |
Recruitment Status
:
Terminated
(No funding for this study)
First Posted
: August 7, 2009
Last Update Posted
: October 21, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Liver Tumors | Drug: Definity® | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 6 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Diagnostic |
Official Title: | Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors |
Study Start Date : | May 2008 |
Actual Primary Completion Date : | June 2009 |
Actual Study Completion Date : | May 2010 |

Arm | Intervention/treatment |
---|---|
Experimental: Definity Contrast Dye
During liver surgery Definity contrast dye will be administered follwed by an ultrasound to better detect liver tumors
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Drug: Definity®
Definity® injections given both pre-ablation and post-ablation
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- adverse events [ Time Frame: 6-weeks post surgery ]
- identification of liver tumors [ Time Frame: intra-operative ]
- improved ablation of liver tumors [ Time Frame: 6-weeks post surgery ]

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Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00955097
United States, Kentucky | |
Norton Healthcare | |
Louisville, Kentucky, United States, 40202 | |
University of Louisville Hospital | |
Louisville, Kentucky, United States, 40202 |
Principal Investigator: | Robert Martin, MD | University of Louisville |
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 |
First Posted: | August 7, 2009 Key Record Dates |
Last Update Posted: | October 21, 2013 |
Last Verified: | October 2013 |
Keywords provided by Robert C. Martin, 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 Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Liver Diseases |