Interventional Sonography Guided by Image Fusion | NCT00781924

Studies
Interventional Sonography Guided by Image Fusion

NCT00781924

Sponsor

Rigshospitalet, Denmark

Status

Completed

Last Update Posted

Aug 8, 2011Estimated

Enrollment

60Estimated

Phase

Not provided

Conditions

Focal Liver Lesions
Focal Lesions in the Abdomen

Interventions

biopsy

Countries

Denmark

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 2009

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

Jan 2008

Primary Completion Date

Mar 2009Actual

Completion Date

Sep 2009Actual

First Submitted Date

Oct 28, 2008

First Submission Date that Met QC Criteria

Oct 28, 2008

First Posted Date

Oct 29, 2008Estimated

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 4, 2011

Last Update Posted Date

Aug 8, 2011Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

The purpose of this study is to register the precision of image fusion between live sonography and CT, MRI or PET/CT of liver lesions and other focal lesions in the abdomen. To test whether it will be possible to biopsy guided by image fusion.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

60Estimated

Label	Type	Description	Intervention Names
biopsy			Procedure: biopsy

Name	Type	Description	Arm Group Labels	Other Names
biopsy	Procedure	ultrasound guided biopsy of tumors.	biopsy

Measure	Description	Time Frame
Verification of the tumor by sonography		baseline only

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Focal liver lesion seen on CT, MRI or PET/CT

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

patients with focal liver lesions where biopsy is needed or the lesion has to be verified by sonography

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Rigshospitalet, Copenhagen University Hospital		Copenhagen	Copenhagen	2100	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
21918674	Derived	Ewertsen C, Henriksen BM, Hansen CP, Knigge U. Synchronous gastric neuroendocrine carcinoma and hepatocellular carcinoma: a case report. BMJ Case Rep. 2009;2009:bcr03.2009.1667. doi: 10.1136/bcr.03.2009.1667. Epub 2009 Sep 15.

ID	Term
D003581	Cytodiagnosis
D003584	Cytological Techniques
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures