A Phase II Study of DMP 115 to Assess Focal Liver Lesions

Phase 2CompletedNCT00162058

Lantheus Medical Imaging80 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Masking

NONE

Enrollment

Conditions

Liver Disease

Interventions

Peflutren Lipid Microsphere Injectable SuspensionDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Local Institution

Glasgow, Scotland, United Kingdom

Outcomes

Primary Outcomes

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 Outcomes

The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.

Data from ClinicalTrials.gov

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