Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization

NCT ID: NCT04780789

Last Updated: 2021-03-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 61 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-02-01
• Study Completion Date: 2019-12-31

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.

Conditions

Hepatocellular Carcinoma; Hepatocellular Carcinoma by BCLC Stage

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

Transarterial Chemoembolization

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.

Intervention Type: PROCEDURE

Other Intervention Names

Transarterial Chemoembolization with Drug-Eluting Beads

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Masaryk Memorial Cancer Institute

OTHER

Sponsor Role: collaborator

Masaryk University

OTHER

Sponsor Role: collaborator

Brno University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Monika Hajkova

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

01-080616/EK

Identifier Type: -

Identifier Source: org_study_id