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NCT Number: NCT04780789

Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization

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.

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Key information

Conditions

Hepatocellular Carcinoma Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Hepatocellular Carcinoma by BCLC Stage Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Transarterial chemoembolization

Procedure

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.

Other names: Transarterial Chemoembolization with Drug-Eluting Beads

Primary outcomes

  1. Predictive factors for overall survival and progression-free survival

    Time frame: 4 years 11 months

    RECIST, mRECIST, volumetric analysis

  2. Interobserver variability of the methods used for assessing tumor response to the treatment

    Time frame: 4 years 11 months

    RECIST, mRECIST, volumetric analysis

Secondary outcomes

  1. Time from observation until death due to any cause (or censoring)

    Time frame: 4 years 11 months

    Overall survival

  2. Time from observation until disease progression or death

    Time frame: 4 years 11 months

    Progression-free survival

  3. Response to the treatment, as assessed by RECIST (v.1.1)

    Time frame: 4 years 11 months

    Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis

  4. Response to the treatment, as assessed by mRECIST

    Time frame: 4 years 11 months

    Objective Tumour Response will be assessed by the investigators on CT/MRI image analysis

  5. Response to the treatment, as assessed by volumetric analysis

    Time frame: 4 years 11 months

    Objective Tumour Response will be assessed by the investigators on CT/MRI image

Sponsors and collaborators

Lead sponsor

Brno University Hospital

Other

Collaborators

  • Masaryk Memorial Cancer Institute
  • Masaryk University

Registry information

Official study title

Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization and Its Impact on Overall Survival

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 4, 2021
Registry last updated
Mar 4, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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