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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00162058
Other study ID # DMP 115-214
Secondary ID
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


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.
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