Liver Disease Clinical Trial
Official title:
An Open-Label, Non-Randomized, Phase II Trial To Assess Focal Liver Lesion Detection Using Definity-Enhanced Ultrasound Imaging
To determine the optimal dose of DMP 115 to image liver lesions and to assess whether contrast can improve the detection of focal liver lesions.
Status | Completed |
Enrollment | 80 |
Est. completion date | April 2006 |
Est. primary completion date | April 2006 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Diagnosed with 1 but <7 focal liver lesions - Scheduled for liver biopsy within 30 days of study - Scheduled for CT or MR within 30 days of study Exclusion Criteria: - Critically ill subjects - Subjects with right-to-left shunts |
Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
United Kingdom | Local Institution | Glasgow | Scotland |
Lead Sponsor | Collaborator |
---|---|
Lantheus Medical Imaging |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The ratio of signal intensities obtained from unenhanced vs. contrast-enhanced ultrasound imaging of liver tissue and liver lesions will be calculated at the end of the study. | |||
Secondary | The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images. |
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