A Phase II Study of DMP 115 to Assess Focal Liver Lesions
Phase 2
Completed
- Conditions
- Liver Disease
- Registration Number
- NCT00162058
- Lead Sponsor
- Lantheus Medical Imaging
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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
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Exclusion Criteria
- Critically ill subjects
- Subjects with right-to-left shunts
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.
Trial Locations
- Locations (1)
Local Institution
🇬🇧Glasgow, Scotland, United Kingdom