NCT00781924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 29, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2009

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

August 8, 2011

Status Verified

August 1, 2009

Enrollment Period

1.2 years

First QC Date

October 28, 2008

Last Update Submit

August 4, 2011

Conditions

Focal Liver LesionsFocal Lesions in the Abdomen

Outcome Measures

Primary Outcomes (1)

  • Verification of the tumor by sonography

    baseline only

Study Arms (1)

biopsy

Procedure: biopsy

Interventions

biopsyPROCEDURE

ultrasound guided biopsy of tumors.

biopsy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rigshospitalet, Copenhagen University Hospital

Copenhagen, Copenhagen, 2100, Denmark

Location

Related Publications (1)

  • 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.

    PMID: 21918674DERIVED

MeSH Terms

Interventions

Biopsy

Intervention Hierarchy (Ancestors)

CytodiagnosisCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisSpecimen HandlingDiagnostic Techniques, SurgicalSurgical Procedures, OperativeInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 28, 2008

First Posted

October 29, 2008

Study Start

January 1, 2008

Primary Completion

March 1, 2009

Study Completion

September 1, 2009

Last Updated

August 8, 2011

Record last verified: 2009-08

Locations

DK(1)