Clinical trial NCT04780789: Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization
Official title: Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization and Its Impact on Overall Survival
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hepatocellular Carcinoma
Hepatocellular Carcinoma by BCLC Stage
Keywords: Transarterial Chemoembolization
RECIST
mRECIST
Volumetric analysis
Lead sponsor: Brno University Hospital
Sponsor class: OTHER
Collaborators: name: Masaryk Memorial Cancer Institute
name: Masaryk University
First posted: 2021-03-04
Enrollment: 61
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with hepatocellular carcinoma undergoing transrarterial chemoembolization

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* when the inclusion criteria are not met.

Primary outcomes:
measure: Predictive factors for overall survival and progression-free survival
timeFrame: 4 years 11 months
measure: Interobserver variability of the methods used for assessing tumor response to the treatment
timeFrame: 4 years 11 months
Secondary outcomes:
measure: Time from observation until death due to any cause (or censoring)
timeFrame: 4 years 11 months
measure: Time from observation until disease progression or death
timeFrame: 4 years 11 months
measure: Response to the treatment, as assessed by RECIST (v.1.1)
timeFrame: 4 years 11 months
measure: Response to the treatment, as assessed by mRECIST
timeFrame: 4 years 11 months
measure: Response to the treatment, as assessed by volumetric analysis
timeFrame: 4 years 11 months
Other outcomes:
Locations:
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