Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization

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.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma; Hepatocellular Carcinoma by BCLC Stage
• Intervention / Treatment: Procedure: Transarterial Chemoembolization

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 Type: Observational
• Enrollment (Actual): 61

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatocellular carcinoma undergoing transrarterial chemoembolization

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time from observation until death due to any cause (or censoring)	Overall survival	4 years 11 months
Time from observation until disease progression or death	Progression-free survival	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	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	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	4 years 11 months

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Collaborators: Masaryk University; Masaryk Memorial Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2015
• Primary Completion (Actual): December 31, 2019
• Study Completion (Actual): December 31, 2019

Study Registration Dates

• First Submitted: February 17, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): March 4, 2021
• Last Update Submitted That Met QC Criteria: March 2, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Keywords: RECIST; Transarterial Chemoembolization; mRECIST; Volumetric analysis
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 01-080616/EK

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No