Focal Liver LesionsNCT00781924
Interventional Sonography Guided by Image Fusion
An observational study of Focal Liver Lesions and Focal Lesions in the Abdomen, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Focal Liver Lesions, Focal Lesions in the Abdomen
- What is being tested?
- biopsy
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2008to Sep 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with focal liver lesions where biopsy is needed or the lesion has to be verified by sonography
Who may be able to join
- Focal liver lesion seen on CT, MRI or PET/CT
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Rigshospitalet, Copenhagen University Hospital
Copenhagen, Copenhagen, 2100
About this study
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.
- Conditions
- Focal Liver Lesions, Focal Lesions in the Abdomen
- Being tested
- biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsyProcedure or surgery
ultrasound guided biopsy of tumors.
| Study group | Role | What they receive |
|---|---|---|
| biopsy | Not described Receives: Procedure: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verification of the tumor by sonography
Measured: baseline only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2008 (estimated)
- Study startJan 2008
- Primary completionMar 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Focal Liver LesionsStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00781924
- Sponsor's protocol ID
- HD-2007-0066
- Status last verified
- Aug 2009
- First submitted
- 28 Oct 2008
- Last updated
- 8 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 21918674
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Sonography Guided by Image Fusion
- ClinicalTrials.gov ID
- NCT00781924
- Acronym / sponsor ID
- HD-2007-0066
- Conditions
- Focal Liver Lesions, Focal Lesions in the Abdomen
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Mar 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 29 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| biopsy | – | Procedure: biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with focal liver lesions where biopsy is needed or the lesion has to be verified by sonography
Key inclusion criteria (1 listed)
- Focal liver lesion seen on CT, MRI or PET/CT
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsyultrasound guided biopsy of tumors. | Procedure or surgery | biopsy |
Primary outcome
Verification of the tumor by sonography
Time frame: baseline only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2011.
- Derived from this study: PubMed 21918674Ewertsen 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Focal Liver Lesions and Focal Lesions in the Abdomen, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verification of the tumor by sonography (time frame: baseline only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00781924, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2011.