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

An Open-Label, Non-Randomized, Phase II Trial To Assess Focal Liver Lesion Detection Using Definity-Enhanced Ultrasound Imaging

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00162058

Enrollment

Registered

2005-09-13

Start date

2004-03-31

Completion date

2006-04-30

Last updated

2011-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Disease

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.

Interventions

DRUGPeflutren Lipid Microsphere Injectable Suspension

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026