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

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00162058
• Other study ID #: DMP 115-214
• Status: Completed
• Phase: Phase 2
• First received: September 9, 2005
• Last updated: August 17, 2011
• Start date: March 2004
• Est. completion date: April 2006

Study information

• Verified date: August 2011
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• 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

Study Design

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Liver Disease
• Liver Diseases

Intervention

Drug:
• Peflutren Lipid Microsphere Injectable Suspension

Locations

Country	Name	City	State
United Kingdom	Local Institution	Glasgow	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
Lantheus Medical Imaging

Country where clinical trial is conducted

United Kingdom, 

Outcome

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.