A Phase II Study of DMP 115 to Assess Focal Liver Lesions | NCT00162058

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

NCT00162058

Sponsor

Lantheus Medical Imaging

Status

Completed

Last Update Posted

Aug 18, 2011Estimated

Enrollment

Phase

Phase 2

Conditions

Liver Disease

Interventions

Peflutren Lipid Microsphere Injectable Suspension

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2004

Primary Completion Date

Apr 2006Actual

Completion Date

Apr 2006Actual

First Submitted Date

Sep 9, 2005

First Submission Date that Met QC Criteria

Sep 9, 2005

First Posted Date

Sep 13, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2011

Last Update Posted Date

Aug 18, 2011Estimated

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Name	Type	Description	Arm Group Labels	Other Names
Peflutren Lipid Microsphere Injectable Suspension	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
The determination of the presence or absence of focal liver lesions during the Blinded Read and the Institutional Read of ultrasound images.

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Edward L.S. Leen, MD	Consultant Radiologist, Royal Infirmary	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Local Institution		Glasgow	Scotland		United Kingdom