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

NCT ID: NCT00162058

Last Updated: 2011-08-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2006-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Liver Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Blinding Strategy

NONE

Interventions

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Peflutren Lipid Microsphere Injectable Suspension

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lantheus Medical Imaging

INDUSTRY

Sponsor Role lead

Responsible Party

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Lantheus Medical Imaging

Principal Investigators

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Edward L.S. Leen, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant Radiologist, Royal Infirmary

Locations

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Local Institution

Glasgow, Scotland, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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DMP 115-214

Identifier Type: -

Identifier Source: org_study_id

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