Hepatocellular CarcinomaCHICNCT00848952
Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis
A study testing 3 imaging techniques are done in people with Hepatocellular Carcinoma, run by University Hospital, Angers at 19 sites in France.
Trial summary
The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI, CTscanner and enhanced contrast ultrasound for the diagnosis of small (< 3 cm) hepatocellular carcinoma for patients with cirrhosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- 3 imaging techniques are done
- How many people
- 450 participants
- Where
- 19 sitesFrance
- Study dates
- Mar 2009to Mar 2010
- Phase
- Interventional
- 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
Who may be able to join
- age > 18 hears
- presence of one or several nodules < 3 cm
- known or suspected cirrhosis
Who cannot join
- psychiatric disease
- contraindication to one of the 3 imaging examinations (CTscanner, MRI, enhanced contrast ultrasound
- patient already treated by chemoembolization
- recurrence on the coagulation zone of a nodule already treated by per-cutaneous tumour destruction
- presence of a tumour (> 3 cm) associated to the nodule
- pregnant woman or breast-feeding woman
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
France19 sites
CHU Angers
Angers
Aubé Christophe, chaube@chu-angers.fr
Aubé Christophe
Hôpital Saint-André
Bordeaux, 33300
Trillaud, herve.trillaud@chu-bordeaux.fr
Trillaud
Chu
Caen, 14033
Le Pennec, lepennec-v@chu-caen.fr
Le Pennec
hôpital Beaujon
Clichy, 92110
Vilgrain, valerie.vilgrain@bjn.aphp.fr
Valérie Vilgrain
hôpital Henri Mondor
Créteil, 94010
Luciani, alain.luciani@hmn.aphp.fr
Luciani
Hôpital Du Bocage
Dijon, 21079
Krause, denis.krause@chu-dijon.fr
Krause
CHU
Grenoble, 38043
Bricault, IBricault@chu-grenoble.fr
Bricault
Hôpital de la croix rousse
Lyon, 69317
Rode, agnes.rode@chu-lyon.fr
Rode
Hôpital E. Herriot
Lyon, 69437
Pilleul, frank.pilleul@chu-lyon.fr
Pilleul
Hôpital Saint Éloi
Montpellier, 34295
Gallix, b-gallix@chu-montpellier.fr
Gallix
Hôpital Brabois
Nancy, 54500
Laurent, v.laurent@chu-nancy.fr
Laurent
Hôpital Hôtel Dieu
Nantes, 44093
Dupas, benoit.dupas@chu-nantes.fr
Dupas
hôpital archet II
Nice, 06003
Chevallier, chevallier.p@chu-nice.fr
Chevallier
Hôpital Saint Antoine
Paris, 75012
Lewin, maite.lewin@sat.aphp.fr
Lewin
Hôpital Haut-Lévèque
Pessac, 33604
Drouillard, jacques.drouillard@chu-bordeaux.fr
Drouillard
Hôpital Pontchaillou
Rennes, 35033
Olivie, damien.olivie@chu-rennes.fr
Olivie
Hôpital Nord
Saint-Etienne, 42055
Cuilleron, muriel.cuilleron@chu-st-etienne.fr
Cuilleron
Hôpital Paul Brousse
Villejuif, 94804
Bellin, marie-france.bellin@bct.aphp.fr
Bellin
Institut Gustave Roussy
Villejuif, 94805
Dromain, dromain@igr.fr
Dromain
About this study
The purpose of this study is to evaluate 3 imaging techniques and their associations : MRI, CTscanner and enhanced contrast ultrasound for the diagnosis of small (< 3 cm) hepatocellular carcinoma for patients with cirrhosis.
Read the detailed description
With the improvement of cirrhosis complications coverage, hepatocellular carcinoma (HCC) tend to become the main cause of mortality for cirrhotic patients. Currently, the incidence of the HCC increase in occidental country and hid global prognostic remain very bad. The main indication factor for a curative treatment is the size lesion.
Cirrhosis is the main risk factor for HCC occurence. In France, HCC screening has been establish for cirrhotic patients with hepatic ultrasound and alfa-fetoprotein measurement with the aim of detected HCC when the size allows a curative treatment.
When a nodule is discovered during the follow-up, HCC diagnosis is done following the recommendations of European Association for the Study of the Liver (AESL) in 2000, updated by the American Association for the Study of Liver Diseases (AASLD)in 2005. Diagnostic is function of nodule feature on one or two enhanced imaging techniques among CTscanner, MRI and enhanced contrast ultrasound.
This diagnostic strategy raises several questions. First, neither the most efficient dynamic imaging association for nodules from 1 to 2 cm, nor the most efficient imaging examination for nodules from 2 to 3 cm are known. Second, only few studies have been carried out about imaging semiology of the small hepatocellular carcinoma. Thus, the imprecisions of the present recommendations regarding the choice of the best examination technique and the difficulties in the diagnosis of benign or malignant nature for small nodule can lead to a bad management of these patients.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- 3 imaging techniques are done
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3 imaging techniques are doneOther
all patients have : MRI, CTscanner, enhanced contrast ultrasound
What is being measured
The primary outcome is the main question the study is designed to answer.
Report of proportion of the positives truths and the positive wrong for an examination
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2009 (estimated)
- Study startMar 2009
- Primary completionMar 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848952
- Sponsor's protocol ID
- PHRC 2008-01
- Acronym
- CHIC
- Status last verified
- Feb 2009
- First submitted
- 20 Feb 2009
- Last updated
- 4 Feb 2010
- Results posted
- No
Publications
Paisant A, Vilgrain V, Riou J, Oberti F, Sutter O, Laurent V, Rodes A, Guiu B, Cassinotto C, Trillaud H, Bricault I, Michalak S, Bruno O, Ronot M, Aube C. Comparison of extracellular and hepatobiliary MR contrast agents for the diagnosis of small HCCs. J Hepatol. 2020 May;72(5):937-945. doi: 10.1016/j.jhep.2019.12.011. Epub 2019 Dec 21.
PubMed 31870951Aube C, Oberti F, Lonjon J, Pageaux G, Seror O, N'Kontchou G, Rode A, Radenne S, Cassinotto C, Vergniol J, Bricault I, Leroy V, Ronot M, Castera L, Michalak S, Esvan M, Vilgrain V; CHIC Group. EASL and AASLD recommendations for the diagnosis of HCC to the test of daily practice. Liver Int. 2017 Oct;37(10):1515-1525. doi: 10.1111/liv.13429. Epub 2017 Apr 26.
PubMed 28346737
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Imaging for the Diagnosis of Small Hepatocellular Carcinoma (< 3 cm)on Cirrhosis
- ClinicalTrials.gov ID
- NCT00848952
- Acronym / sponsor ID
- CHIC / PHRC 2008-01
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- Mar 2009
- Primary completion
- Mar 2010 (estimated)
- First posted
- 23 Feb 2009 (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 evaluate 3 imaging techniques and their associations : MRI, CTscanner and enhanced contrast ultrasound for the diagnosis of small (< 3 cm) hepatocellular carcinoma for patients with cirrhosis.
Detailed description
With the improvement of cirrhosis complications coverage, hepatocellular carcinoma (HCC) tend to become the main cause of mortality for cirrhotic patients. Currently, the incidence of the HCC increase in occidental country and hid global prognostic remain very bad. The main indication factor for a curative treatment is the size lesion.
Cirrhosis is the main risk factor for HCC occurence. In France, HCC screening has been establish for cirrhotic patients with hepatic ultrasound and alfa-fetoprotein measurement with the aim of detected HCC when the size allows a curative treatment.
When a nodule is discovered during the follow-up, HCC diagnosis is done following the recommendations of European Association for the Study of the Liver (AESL) in 2000, updated by the American Association for the Study of Liver Diseases (AASLD)in 2005. Diagnostic is function of nodule feature on one or two enhanced imaging techniques among CTscanner, MRI and enhanced contrast ultrasound.
This diagnostic strategy raises several questions. First, neither the most efficient dynamic imaging association for nodules from 1 to 2 cm, nor the most efficient imaging examination for nodules from 2 to 3 cm are known. Second, only few studies have been carried out about imaging semiology of the small hepatocellular carcinoma. Thus, the imprecisions of the present recommendations regarding the choice of the best examination technique and the difficulties in the diagnosis of benign or malignant nature for small nodule can lead to a bad management of these patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- age > 18 hears
- presence of one or several nodules < 3 cm
- known or suspected cirrhosis
Key exclusion criteria (6 listed)
- psychiatric disease
- contraindication to one of the 3 imaging examinations (CTscanner, MRI, enhanced contrast ultrasound
- patient already treated by chemoembolization
- recurrence on the coagulation zone of a nodule already treated by per-cutaneous tumour destruction
- presence of a tumour (> 3 cm) associated to the nodule
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 |
|---|---|---|
| 3 imaging techniques are doneall patients have : MRI, CTscanner, enhanced contrast ultrasound | Other | – |
Primary outcome
Report of proportion of the positives truths and the positive wrong for an examination
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2010.
- Derived from this study: PubMed 31870951Paisant A, Vilgrain V, Riou J, Oberti F, Sutter O, Laurent V, Rodes A, Guiu B, Cassinotto C, Trillaud H, Bricault I, Michalak S, Bruno O, Ronot M, Aube C. Comparison of extracellular and hepatobiliary MR contrast agents for the diagnosis of small HCCs. J Hepatol. 2020 May;72(5):937-945. doi: 10.1016/j.jhep.2019.12.011. Epub 2019 Dec 21.
- Derived from this study: PubMed 28346737Aube C, Oberti F, Lonjon J, Pageaux G, Seror O, N'Kontchou G, Rode A, Radenne S, Cassinotto C, Vergniol J, Bricault I, Leroy V, Ronot M, Castera L, Michalak S, Esvan M, Vilgrain V; CHIC Group. EASL and AASLD recommendations for the diagnosis of HCC to the test of daily practice. Liver Int. 2017 Oct;37(10):1515-1525. doi: 10.1111/liv.13429. Epub 2017 Apr 26.
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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.
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3 imaging techniques are done in people with Hepatocellular Carcinoma, run by University Hospital, Angers at 19 sites in France.
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 6 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 4 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in France. 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 Christophe Aube, professor (33-(0)2-41-35-42-81, chaube@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Report of proportion of the positives truths and the positive wrong for an examination (time frame: one year). 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 NCT00848952, which also lists 2 linked publications.
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 4 Feb 2010.