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

This study has been completed.
Sponsor:
Information provided by:
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT00162058
First received: September 9, 2005
Last updated: August 17, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Liver Disease
 Drug: Peflutren Lipid Microsphere Injectable Suspension
 Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Open-Label, Non-Randomized, Phase II Trial To Assess Focal Liver Lesion Detection Using Definity-Enhanced Ultrasound Imaging

Resource links provided by NLM:

MedlinePlus related topics: Liver Diseases
U.S. FDA Resources

Further study details as provided by Lantheus Medical Imaging:

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

Estimated Enrollment: 80
Study Start Date: March 2004
Study Completion Date: April 2006
Primary Completion Date: April 2006 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00162058

Locations
United Kingdom
Local Institution
Glasgow, Scotland, United Kingdom
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Principal Investigator: Edward L.S. Leen, MD Consultant Radiologist, Royal Infirmary
  More Information

No publications provided

Responsible Party: Qi Zhu, MD Sr. Medical Director, Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT00162058     History of Changes
Other Study ID Numbers: DMP 115-214
Study First Received: September 9, 2005
Last Updated: August 17, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on May 23, 2013