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Lipid Profile |
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Clinical Trial: A Phase II Study of DMP 115 to Assess Focal Liver Lesions
This study is currently recruiting patients.
Verified by Bristol-Myers Squibb September 2005
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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 II |
MedlinePlus related topics: Liver Diseases
Study Type: Interventional
Study Design: Educational/Counseling/Training, Non-Randomized, Open Label, Historical Control, Single Group Assignment
Official Title: An Open-Label, Non-Randomized, Phase II Trial To Assess Focal Liver Lesion Detection Using Definity-Enhanced Ultrasound Imaging
Further Study Details:
Primary Outcomes: 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 Outcomes: The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.
Expected Total Enrollment: 80
Secondary Outcomes: The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.
Expected Total Enrollment: 80
Study start: March 2004
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for Study: Both
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
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00162058
BMS Call Center For Outside Us and Canada 215-347-4079 Ext. 207
United Kingdom, Scotland
Local Institution, Glasgow, Scotland, United Kingdom; Recruiting
Study chairs or principal investigators
Edward L.S. Leen, MD, Principal Investigator, Consultant Radiologist, Royal Infirmary
More Information
Study ID Numbers: DMP 115-214
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162058
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-13
Last Updated: September 12, 2005
Record first received: September 9, 2005
ClinicalTrials.gov Identifier: NCT00162058
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
ClinicalTrials.gov processed this record on 2005-09-13
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