Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors (Definity®)
The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by University of Louisville.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
University of Louisville
Information provided by:
University of Louisville
ClinicalTrials.gov Identifier:
NCT00955097
First received: August 6, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
| Tracking Information | |||||
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| First Received Date ICMJE | August 6, 2009 | ||||
| Last Updated Date | August 6, 2009 | ||||
| Start Date ICMJE | May 2008 | ||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
improved ablation of liver tumors [ Time Frame: 6-weeks post surgery ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors | ||||
| Official Title ICMJE | Evaluation of Intra-operative Ultrasound Contrast Enhancement in the Evaluation of Liver Tumors | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Liver Tumors | ||||
| Intervention ICMJE | Drug: Definity®
Definity® injections given both pre-ablation and post-ablation
Other Name: Definity® |
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| Study Arm (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Recruiting | ||||
| Estimated Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | May 2010 | ||||
| Estimated Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: 1. Not a suitable candidate for operation |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00955097 | ||||
| Other Study ID Numbers ICMJE | Definity 08.0119, 08.0119 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Dr. Robert C. G. Martin, University of Louisville | ||||
| Study Sponsor ICMJE | University of Louisville | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Louisville | ||||
| Verification Date | August 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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