Hepatocellular CarcinomaNCT04780789
Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization
An observational study of Hepatocellular Carcinoma and Hepatocellular Carcinoma by BCLC Stage, run by Brno University Hospital.
Trial summary
The application of transarterial chemoembolisation (TACE) with drug-eluting beads in patients with hepatocellular carcinoma and its response to the treatment will be observed. The registry has the following objectives: To assess the response to the treatment by standard methods and volumetric analysis as well as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatocellular Carcinoma, Hepatocellular Carcinoma by BCLC Stage
- What is being tested?
- Transarterial Chemoembolization
- Type of treatment
- Surgery or procedure
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- 1 Feb 2015to 31 Dec 2019
- 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 hepatocellular carcinoma undergoing transrarterial chemoembolization
Who may be able to join
- diagnosis of HCC by a radiologist according to the European Association for the Study of the Liver (EASL) criteria or confirmed histologically
- at least one TACE undergone at the University Hospital Brno
- initial/ closing CT (Brillance 64, Philips, Netherlands; contrast enhancement 125 mL Iomeron 400, Bracco, Germany) or MRI study (Achieva, Philips, Netherlands, SENSE XL Torso coil 16 1.5T; contrast enhancement 15 mL Primovist, Bayer, Germany)
- follow-up on or before December 31, 2019.
Who cannot join
- when the inclusion criteria are not met.
About this study
Official title: Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization and Its Impact on Overall Survival
The application of transarterial chemoembolisation (TACE) with drug-eluting beads in patients with hepatocellular carcinoma and its response to the treatment will be observed. The registry has the following objectives:
To assess the response to the treatment by standard methods and volumetric analysis as well as trying to determine any predictive response factors To determinate interobserver variability of the methods.
Read the detailed description
The patients with hepatocellular carcinoma in stage suitable for treatment by transarterial chemoembolization (TACE) with drug-eluting beads are included in the study. The investigators assess the response to the treatment by standard methods (RECIST, mRECIST) as well as by volumetric analysis. The size of tumor is evaluated on CT/MRI by two investigators prior to first TACE and then on all the check-ups (routinely every three months) until 31 December, 2019 or the patients' death.
- Being tested
- Transarterial Chemoembolization
- Keywords
- Transarterial Chemoembolization, RECIST, mRECIST, Volumetric analysis
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transarterial ChemoembolizationProcedure or surgery
Also called Transarterial Chemoembolization with Drug-Eluting Beads
A contrast agent (Xenetix350, Guerbet, France) was applied under local anaesthesia via the common femoral artery using a 5F sheath. Selective catheterization of the coeliac trunk and other arteries supplying the liver was then performed under fluoroscopic control. A pathological vascularization pattern was identified and chemoembolization material consisting of DC beads (BTG International Ltd) was injected by the treating angiographist using micro instrumentation. Follow-up CT or MRI was performed after 1-3 TACE sessions according to the extent of the lesion, 3 weeks following the last procedure. Patients with completed treatments were scheduled for an imaging follow-up every 3 months, allowing evaluation of the effect of treatment. In case of a positive response to the treatment another session of TACE was indicated. Chemoembolization sessions were performed as inpatient procedures with the mean hospitalization time of 4 days.
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive factors for overall survival and progression-free survival
RECIST, mRECIST, volumetric analysis
Measured: 4 years 11 months
Interobserver variability of the methods used for assessing tumor response to the treatment
RECIST, mRECIST, volumetric analysis
Measured: 4 years 11 months
Secondary outcomes (5)
Time from observation until death due to any cause (or censoring)
Overall survival
Measured: 4 years 11 months
Time from observation until disease progression or death
Progression-free survival
Measured: 4 years 11 months
Response to the treatment, as assessed by RECIST (v.1.1)
Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis
Measured: 4 years 11 months
Response to the treatment, as assessed by mRECIST
Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis
Measured: 4 years 11 months
Response to the treatment, as assessed by volumetric analysis
Objective Tumour Response will be assessed by the investigators on CT/MRI image
Measured: 4 years 11 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start1 Feb 2015
- Primary completion31 Dec 2019
- Study completion31 Dec 2019
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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk Memorial Cancer Institute, Masaryk University
- Responsible party
- Principal investigator, Monika Hajkova, Brno University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780789
- Sponsor's protocol ID
- 01-080616/EK
- Status last verified
- Mar 2021
- First submitted
- 17 Feb 2021
- Last updated
- 4 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization and Its Impact on Overall Survival
- ClinicalTrials.gov ID
- NCT04780789
- Acronym / sponsor ID
- 01-080616/EK
- Keywords
- Transarterial Chemoembolization, RECIST, mRECIST, Volumetric analysis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk Memorial Cancer Institute, Masaryk University
- Study start
- 1 Feb 2015 (actual)
- Primary completion
- 31 Dec 2019 (actual)
- Study completion
- 31 Dec 2019 (actual)
- First posted
- 4 Mar 2021 (actual)
- 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 application of transarterial chemoembolisation (TACE) with drug-eluting beads in patients with hepatocellular carcinoma and its response to the treatment will be observed. The registry has the following objectives:
To assess the response to the treatment by standard methods and volumetric analysis as well as trying to determine any predictive response factors To determinate interobserver variability of the methods.
Detailed description
The patients with hepatocellular carcinoma in stage suitable for treatment by transarterial chemoembolization (TACE) with drug-eluting beads are included in the study. The investigators assess the response to the treatment by standard methods (RECIST, mRECIST) as well as by volumetric analysis. The size of tumor is evaluated on CT/MRI by two investigators prior to first TACE and then on all the check-ups (routinely every three months) until 31 December, 2019 or the patients' death.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with hepatocellular carcinoma undergoing transrarterial chemoembolization
Key inclusion criteria (4 listed)
- diagnosis of HCC by a radiologist according to the European Association for the Study of the Liver (EASL) criteria or confirmed histologically
- at least one TACE undergone at the University Hospital Brno
- initial/ closing CT (Brillance 64, Philips, Netherlands; contrast enhancement 125 mL Iomeron 400, Bracco, Germany) or MRI study (Achieva, Philips, Netherlands, SENSE XL Torso coil 16 1.5T; contrast enhancement 15 mL Primovist, Bayer, Germany)
- follow-up on or before December 31, 2019.
Key exclusion criteria (1 listed)
- when the inclusion criteria are not met.
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 |
|---|---|---|
| Transarterial ChemoembolizationAlso: Transarterial Chemoembolization with Drug-Eluting BeadsA contrast agent (Xenetix350, Guerbet, France) was applied under local anaesthesia via the common femoral artery using a 5F sheath. Selective catheterization of the coeliac trunk and other arteries supplying the liver was then performed under fluoroscopic control. A pathological vascularization pattern was identified and chemoembolization material consisting of DC beads (BTG International Ltd) was injected by the treating angiographist using micro instrumentation. Follow-up CT or MRI was performed after 1-3 TACE sessions according to the extent of the lesion, 3 weeks following the last procedure. Patients with completed treatments were scheduled for an imaging follow-up every 3 months, allowing evaluation of the effect of treatment. In case of a positive response to the treatment another session of TACE was indicated. Chemoembolization sessions were performed as inpatient procedures with the mean hospitalization time of 4 days. | Procedure or surgery | – |
Primary outcome
Predictive factors for overall survival and progression-free survival
Time frame: 4 years 11 months
RECIST, mRECIST, volumetric analysis
Interobserver variability of the methods used for assessing tumor response to the treatment
Time frame: 4 years 11 months
RECIST, mRECIST, volumetric analysis
5 secondary outcomes
Time from observation until death due to any cause (or censoring)
Time frame: 4 years 11 months
Time from observation until disease progression or death
Time frame: 4 years 11 months
Response to the treatment, as assessed by RECIST (v.1.1)
Time frame: 4 years 11 months
Response to the treatment, as assessed by mRECIST
Time frame: 4 years 11 months
Response to the treatment, as assessed by volumetric analysis
Time frame: 4 years 11 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 4 Mar 2021.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatocellular Carcinoma and Hepatocellular Carcinoma by BCLC Stage, run by Brno University Hospital.
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 4 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: finished, as of the sponsor's last update on 4 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Predictive factors for overall survival and progression-free survival (time frame: 4 years 11 months). The study lists 2 primary outcomes in all. 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 4 Mar 2021.