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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00162058
Recruitment Status : Completed
First Posted : September 13, 2005
Last Update Posted : August 18, 2011
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Liver Disease Drug: Peflutren Lipid Microsphere Injectable Suspension Phase 2

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Study Type : Interventional  (Clinical Trial)
Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: An Open-Label, Non-Randomized, Phase II Trial To Assess Focal Liver Lesion Detection Using Definity-Enhanced Ultrasound Imaging
Study Start Date : March 2004
Actual Primary Completion Date : April 2006
Actual Study Completion Date : April 2006

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Primary Outcome Measures :
  1. 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 :
  1. The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00162058


Locations
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United Kingdom
Local Institution
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
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Principal Investigator: Edward L.S. Leen, MD Consultant Radiologist, Royal Infirmary
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Responsible Party: Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162058    
Other Study ID Numbers: DMP 115-214
First Posted: September 13, 2005    Key Record Dates
Last Update Posted: August 18, 2011
Last Verified: August 2011
Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases