Hepatocellular CarcinomaPhase 4DCE-MRINCT01806740
DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
A Phase 4 study testing Gadoterate meglumine in people with Hepatocellular Carcinoma, run by Guerbet at 1 site in South Korea.
Trial summary
The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC) to treatment with Sorafenib assessed by mRECIST. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hepatocellular Carcinoma
- What is being tested?
- Gadoterate meglumine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 37 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 May 2013to 12 Oct 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Male and female adult patients (age ≥ 20 years old)
- Patients diagnosed with unresectable HCC [Child Pugh class A and major vascular invasion, extrahapatic metastasis, or progression after transarterial chemoembolization more than 2 times]
- Presence of mRECIST target lesion within liver [lesion which can be classified as a RECIST measurable lesion (can be measured ≥ 1 cm in at least one dimension), lesion suitable for repeated measure, lesion showing intraluminal arterial enhancement on contrast-enhanced CT or MRI]
- Patients planned to be treated with sorafenib
- Patient with liver CT performed or planned to be performed within 4 weeks before initiation of sorafenib treatment
- Patient with a life expectancy of 12 weeks or more
- No previous treatment with sorafenib
- Female patients who are surgically sterilized, or post-menopausal (minimum 12 months of amenorrhea) or who have a documented negative urine hCG test at screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase IV Study of DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC) to treatment with Sorafenib assessed by mRECIST.
Read the detailed description
One of the secondary objectives was to evaluate the correlation between DCE-MRI perfusion parameters at baseline and:
- Overall Survival (OS)
- Progression-Free Survival (PFS)
- Time to Progression (TTP)
Three DCE-MRI examinations were done during the study:
- at the enrolment and initiation of the sorafenib treatment
- one week after initiation of the sorafenib treatment
- two weeks after initiation of the sorafenib treatment
DCE-MRI perfusion parameters were assessed by a centralized radiologist at baseline (corresponding to the day of enrolment and initiation of Sorafenib treatment), week 1 and week 2.
According to mRECIST criteria, HCC lesions were evaluated on computed tomography images by two on-site radiologists at the time of enrolment and 8 weeks later (2 months). OS, PFS and TTP were calculated from survival and tumor progression data recorded one year after initiation of the sorafenib treatment.
- Conditions
- Hepatocellular Carcinoma
- Being tested
- Gadoterate meglumine
- Keywords
- DCE-MRI, Sorafenib response
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Gadoterate meglumineDrug
Also called gadoteric acid, Dotarem
Gadoterate meglumine was administered at a dose of 0.1 mmol/kg (0.2 mL/kg) using a power injector, in an intravenous bolus at a rate of 3 mL/sec.
| Study group | Role | What they receive |
|---|---|---|
| Gadoterate meglumine | Experimental | there is one single arm of patients (no comparative arm) Receives: Drug: Gadoterate meglumine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib
To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, Wash-in, Washout) at baseline, week 1 and week 2, and the response of target lesions to sorafenib.
- Ktrans: volume transfer constant between blood plasma and extravascular extracellular space
- AUC : area under the curve of tissue gadolinium concentration-time
- ve: fractional volume of extravascular extracellular space
- kep: rate constant between extravascular extracellular space and blood plasma (=Ktrans/ve)
- T1: longitudinal relaxation time
- Wash-in: slope of the early enhancement curve
- Washout: slope of the late enhancement curve
The response of target lesions was assessed by mRECIST at 2 months after initiation of treatment (sorafenib).
The correlation analyses were done using Pearson or Spearman correlation coefficient.
Measured: 3 months
Secondary outcomes (3)
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival
To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and overall survival.
The overall survival was calculated from the patient's survival status recorded one year after initiation of the sorafenib treatment.
The correlation analyses were done using Pearson or Spearman correlation coefficient.
Measured: 1 year
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival
To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and progression free survival.
The progression free survival was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment.
The correlation analyses were done using Pearson or Spearman correlation coefficient.
Measured: 1 year
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression
To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, wash-in, washout) at baseline and time to progression.
The time to progression was calculated from the patient's survival status and tumor progression status recorded one year after initiation of the sorafenib treatment.
The correlation analyses were done using Pearson or Spearman correlation coefficient.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2013 (estimated)
- Study start9 May 2013
- Primary completion12 Oct 2015
- Study completion12 Oct 2015
Why it stopped: The planned number of enrolled patients was not reached.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guerbet
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeong Min Lee, Ph.D, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01806740
- Sponsor's protocol ID
- DGD-44-057
- Acronym
- DCE-MRI
- Status last verified
- Jun 2019
- First submitted
- 6 Nov 2012
- Last updated
- 8 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Undecided: It will be decided after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Study of DCE-MRI Using Dotarem® in Evaluation of Therapeutic Response to Sorafenib in Patients With Advanced Stage HCC
- ClinicalTrials.gov ID
- NCT01806740
- Acronym / sponsor ID
- DCE-MRI / DGD-44-057
- Conditions
- Hepatocellular Carcinoma
- Keywords
- DCE-MRI, Sorafenib response
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The planned number of enrolled patients was not reached.
- Enrolment
- 37 participants (actual)
- Lead sponsor
- GuerbetIndustry (pharma, biotech, devices)
- Study start
- 9 May 2013 (actual)
- Primary completion
- 12 Oct 2015 (actual)
- Study completion
- 12 Oct 2015 (actual)
- First posted
- 7 Mar 2013 (estimated)
- Results
- Posted 8 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective is to evaluate the value of dynamic contrast-enhanced Magnetic Resonance Imaging (DCE-MRI) in prediction of response of patients with hepatocellular carcinoma (HCC) to treatment with Sorafenib assessed by mRECIST.
Detailed description
One of the secondary objectives was to evaluate the correlation between DCE-MRI perfusion parameters at baseline and:
- Overall Survival (OS)
- Progression-Free Survival (PFS)
- Time to Progression (TTP)
Three DCE-MRI examinations were done during the study:
- at the enrolment and initiation of the sorafenib treatment
- one week after initiation of the sorafenib treatment
- two weeks after initiation of the sorafenib treatment
DCE-MRI perfusion parameters were assessed by a centralized radiologist at baseline (corresponding to the day of enrolment and initiation of Sorafenib treatment), week 1 and week 2.
According to mRECIST criteria, HCC lesions were evaluated on computed tomography images by two on-site radiologists at the time of enrolment and 8 weeks later (2 months). OS, PFS and TTP were calculated from survival and tumor progression data recorded one year after initiation of the sorafenib treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gadoterate meglumine | Experimental | Drug: Gadoterate megluminethere is one single arm of patients (no comparative arm) |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Gadoterate meglumineAlso: gadoteric acid, DotaremGadoterate meglumine was administered at a dose of 0.1 mmol/kg (0.2 mL/kg) using a power injector, in an intravenous bolus at a rate of 3 mL/sec. | Drug | Gadoterate meglumine |
Primary outcome
Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib
Time frame: 3 months
To evaluate the correlation between DCE-MRI perfusion parameters (Ktrans, AUC, ve, kep, T1, Wash-in, Washout) at baseline, week 1 and week 2, and the response of target lesions to sorafenib. * Ktrans: volume transfer constant between blood plasma and extravascular extracellular space * AUC : area under the curve of tissue gadolinium concentration-time * ve: fractional volume of extravascular extracellular space * kep: rate constant between extravascular extracellular space and blood plasma (=Ktrans/ve) * T1: longitudinal relaxation time * Wash-in: slope of the early enhancement curve * Washout: slope of the late enhancement curve The response of target lesions was assessed by mRECIST at 2 months after initiation of treatment (sorafenib). The correlation analyses were done using Pearson or Spearman correlation coefficient.
3 secondary outcomes
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Overall Survival
Time frame: 1 year
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Progression Free Survival
Time frame: 1 year
Correlation Coefficient Between DCE-MRI Perfusion Parameters at Baseline and Time to Progression
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided. It will be decided after study completion.
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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.
Jeong Min Lee, Ph.D principal investigator
Seoul National University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Gadoterate meglumine in people with Hepatocellular Carcinoma, run by Guerbet at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: stopped early, as of the sponsor's last update on 8 Aug 2019. 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 South Korea. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Correlation Coefficient Between DCE-MRI Perfusion Parameters and the Response of Target Lesions to Sorafenib (time frame: 3 months). 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 8 Aug 2019.