Hepatocellular CarcinomaNCT00474734
Intravascular Ultrasound for Hepatocellular Carcinoma Staging
An observational study of Hepatocellular Carcinoma, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
To diagnose hepatocellular carcinoma (HCC) and to determine the extent of the disease, a triphasic CT scan or a magnetic resonance imaging are required. The characterization of hepatic nodules is more difficult when the HCC lesions have a diameter of less than 2 cm. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Intravascular ultrasound of the liver
- Type of treatment
- Medical device
- How many people
- Not given
- Where
- 1 siteSwitzerland
- Study dates
- May 2007to Sep 2007
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- hepatocellular carcinoma nodules
- patient on liver transplantation waiting list
- written informed consent
Who cannot join
- thrombosis of hepatic veins or vena cava
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University Hospital Geneva
Geneva
Andrea De Gottardi, MD PhD, +41 22 37 29 256, andrea.degottardi@hcuge.ch
About this study
Official title: Intravascular Ultrasound for the Staging of Hepatocellular Carcinoma: a Pilot Study
To diagnose hepatocellular carcinoma (HCC) and to determine the extent of the disease, a triphasic CT scan or a magnetic resonance imaging are required. The characterization of hepatic nodules is more difficult when the HCC lesions have a diameter of less than 2 cm.
Since accuracy in the assessment of the number and the size of HCC nodules, as well as of the invasion of blood vessels is crucial to determine outcome after liver transplantation due to tumour recurrence, there is a need for techniques with a higher definition potential.
As a consequence, to improve outcome and to optimize organ allocation, patients on the liver transplantation waiting list might benefit from intravascular ultrasound as an additional examination to complete the pre-transplant tumour staging process.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Intravascular ultrasound of the liver
- Keywords
- hepatocellular carcinoma, liver transplantation, staging, intravascular ultrasound
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravascular ultrasound of the liverDevice
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2007 (estimated)
- Study startMay 2007
- Study completionSep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe 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
- Defined population
- Time perspective
- Prospective
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Antoine Hadengue, Prof., Study chair, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00474734
- Sponsor's protocol ID
- 07-063
- Status last verified
- May 2007
- First submitted
- 15 May 2007
- Last updated
- 17 May 2007
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravascular Ultrasound for the Staging of Hepatocellular Carcinoma: a Pilot Study
- ClinicalTrials.gov ID
- NCT00474734
- Acronym / sponsor ID
- 07-063
- Conditions
- Hepatocellular Carcinoma
- Keywords
- hepatocellular carcinoma, liver transplantation, staging, intravascular ultrasound
- Study type
- Observational
- Recruitment status
- Unknown status
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- May 2007
- Study completion
- Sep 2007 (estimated)
- First posted
- 17 May 2007 (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.
To diagnose hepatocellular carcinoma (HCC) and to determine the extent of the disease, a triphasic CT scan or a magnetic resonance imaging are required. The characterization of hepatic nodules is more difficult when the HCC lesions have a diameter of less than 2 cm.
Since accuracy in the assessment of the number and the size of HCC nodules, as well as of the invasion of blood vessels is crucial to determine outcome after liver transplantation due to tumour recurrence, there is a need for techniques with a higher definition potential.
As a consequence, to improve outcome and to optimize organ allocation, patients on the liver transplantation waiting list might benefit from intravascular ultrasound as an additional examination to complete the pre-transplant tumour staging process.
Study design
- Observational model
- Defined population
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- hepatocellular carcinoma nodules
- patient on liver transplantation waiting list
- written informed consent
Key exclusion criteria (1 listed)
- thrombosis of hepatic veins or vena cava
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 |
|---|---|---|
| Intravascular ultrasound of the liver | Device | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2007.
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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.
Antoine Hadengue, Prof. study chair
University Hospital, Geneva
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 Hepatocellular Carcinoma, run by University Hospital, Geneva at 1 site in Switzerland.
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 3 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 17 May 2007. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Antoine Hadengue, Prof. (+41 22 37 29 340, antoine.hadengue@hcuge.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
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 17 May 2007.