Hepatocellular CarcinomaICYNCT02003339
Interest of Functional MRI (Magnetic Resonance Imagery) (in Patients Suffering From Hepatocellular Carcinoma and Treated With Yttrium
A study testing Additional RMIs in people with Hepatocellular Carcinoma, run by Center Eugene Marquis at 1 site in France.
Trial summary
For patients who are suffering from hepatocellular carcinoma and are treated with radioembolization, the purpose of this study is to analyse parameters of functional MRIs that are modified early and to detect parameters that vary significantly after treatment. 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?
- Additional RMIs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to 8 Nov 2017
- 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
- Early, intermediate, advanced, non metastatic Hepatocellular Carcinoma. Indication for radioembolization validated after pluridisciplinary committee meeting.
- Isolated target on initial imagery (invasive hepatocellular carcinoma excluded)
- WHO (World Health organization) Performance status: 0, 1 or 2
- If cirrhosis, Child A score with total bilirubin less than 30 micromoles per liter
- Creatinine clearance more or equal to 30 mL/min
- Patient informed and consent signature obtained
Who cannot join
- Invasive hepatocellular carcinoma without any isolated tumor
- Disease needing 2 injections of Therasphere
- Thrombosis extending into the porta(thrombosis of one of left or right branch authorized), extra hepatic metastasis
- Previous treatment by chemoembolization, radiofrequency less than 3 months before radioembolization
- No antiangiogenic concomitant treatment, 15 days before and 15 days after radioembolization, including Sorafenib
- Associated disease which could prevent patient from receiving treatment
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- RMI contre-indication(particle or metal prosthesis, pacemaker, claustrophobia) or contrast product contre-indication (allergy)
- Patient already participating in an other therapeutic trial with an experimental drug
- Pregnant or childbearing potential women or breastfeeding women
- minors, persons deprived of liberty or protected adults (maintenance of justice, guardianship or supervision) Unable to comply with trial medical follow-up for geographical, social or psychological reasons
- Unable to sign an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma
For patients who are suffering from hepatocellular carcinoma and are treated with radioembolization, the purpose of this study is to analyse parameters of functional MRIs that are modified early and to detect parameters that vary significantly after treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Additional RMIs
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Additional RMIsOther
| Study group | Role | What they receive |
|---|---|---|
| RMIs | Experimental | Not described Receives: Other: Additional RMIs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modifications of functional MRI parameters
Measured: Before radioembolization and up to 6 months after radioembolization
Secondary outcomes (3)
Correlation between functional MRIs parameters and tumoral response
Measured: Measured 6 months after radioembolization
Assessment of alternative morphological response criteria : EASL (European Association for study of the liver) and mRECIST (m response evaluation criteria in solid tumor) criteria. Link with RECIST response.
Measured: 2 and 6 months
Change of VEGF (vascular endothelial growth factor) release
Measured: From day 0 to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2013 (estimated)
- Study startNov 2013
- Primary completion8 Nov 2017
- Study completion8 Nov 2017
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.
- 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Center Eugene Marquis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien EDELINE, MD, Principal investigator, Centre Eugène Marquis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02003339
- Sponsor's protocol ID
- 2012-JE-CHC-Pron
- Other IDs
- 2012-A00972-41
- Acronym
- ICY
- Status last verified
- Jan 2017
- First submitted
- 25 Nov 2013
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Prospective Study on Interest of Functional MRI in Early Assessment of Radioembolization Efficiency in Patients Suffering From Hepatocellular Carcinoma
- ClinicalTrials.gov ID
- NCT02003339
- Acronym / sponsor ID
- ICY / 2012-JE-CHC-Pron
- Conditions
- Hepatocellular Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Center Eugene MarquisUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- 8 Nov 2017 (actual)
- Study completion
- 8 Nov 2017 (actual)
- First posted
- 6 Dec 2013 (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.
For patients who are suffering from hepatocellular carcinoma and are treated with radioembolization, the purpose of this study is to analyse parameters of functional MRIs that are modified early and to detect parameters that vary significantly after treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RMIs | Experimental | Other: Additional RMIs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Early, intermediate, advanced, non metastatic Hepatocellular Carcinoma. Indication for radioembolization validated after pluridisciplinary committee meeting.
- Isolated target on initial imagery (invasive hepatocellular carcinoma excluded)
- WHO (World Health organization) Performance status: 0, 1 or 2
- If cirrhosis, Child A score with total bilirubin less than 30 micromoles per liter
- Creatinine clearance more or equal to 30 mL/min
Key exclusion criteria (11 listed)
- Invasive hepatocellular carcinoma without any isolated tumor
- Disease needing 2 injections of Therasphere
- Thrombosis extending into the porta(thrombosis of one of left or right branch authorized), extra hepatic metastasis
- Previous treatment by chemoembolization, radiofrequency less than 3 months before radioembolization
- No antiangiogenic concomitant treatment, 15 days before and 15 days after radioembolization, including Sorafenib
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 |
|---|---|---|
| Additional RMIs | Other | RMIs |
Primary outcome
Modifications of functional MRI parameters
Time frame: Before radioembolization and up to 6 months after radioembolization
3 secondary outcomes
Correlation between functional MRIs parameters and tumoral response
Time frame: Measured 6 months after radioembolization
Assessment of alternative morphological response criteria : EASL (European Association for study of the liver) and mRECIST (m response evaluation criteria in solid tumor) criteria. Link with RECIST response.
Time frame: 2 and 6 months
Change of VEGF (vascular endothelial growth factor) release
Time frame: From day 0 to 2 months
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 22 Nov 2017.
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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.
Julien EDELINE, MD principal investigator
Centre Eugène Marquis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Additional RMIs in people with Hepatocellular Carcinoma, run by Center Eugene Marquis at 1 site 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 6 inclusion and 11 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 22 Nov 2017. 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 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?
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?
Modifications of functional MRI parameters (time frame: Before radioembolization and up to 6 months after radioembolization). It is what the study was designed to measure, not a finding.
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 22 Nov 2017.