Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization

Completed

• Conditions: Hepatocellular Carcinoma by BCLC Stage; Hepatocellular Carcinoma

• Registration Number: NCT04780789
• Lead Sponsor: Brno University Hospital

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.

Study Timeline

• Study Start: 2015-02-01
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Study First Submitted: 2021-02-17
• Status Verified: 2021-03
• Study First Submitted QC: 2021-03-02
• Last Update Submitted: 2021-03-02
• Study First Posted: 2021-03-04
• Last Update Posted: 2021-03-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Interobserver variability of the methods used for assessing tumor response to the treatment	4 years 11 months	RECIST, mRECIST, volumetric analysis
Predictive factors for overall survival and progression-free survival	4 years 11 months	RECIST, mRECIST, volumetric analysis

Secondary Outcome Measures

Name	Time	Method
Response to the treatment, as assessed by mRECIST	4 years 11 months	Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis
Response to the treatment, as assessed by volumetric analysis	4 years 11 months	Objective Tumour Response will be assessed by the investigators on CT/MRI image
Time from observation until disease progression or death	4 years 11 months	Progression-free survival
Response to the treatment, as assessed by RECIST (v.1.1)	4 years 11 months	Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis
Time from observation until death due to any cause (or censoring)	4 years 11 months	Overall survival