Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization

• ClinicalTrials.gov Identifier: NCT04780789
• Recruitment Status: Completed
• First Posted: March 4, 2021
• Last Update Posted: March 4, 2021
• Sponsor: Brno University Hospital
• Collaborators: Masaryk Memorial Cancer Institute; Masaryk University
• Information provided by (Responsible Party): Monika Hajkova, Brno University Hospital

Study Description

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.

Condition or disease	Intervention/treatment
Hepatocellular Carcinoma; Hepatocellular Carcinoma by BCLC Stage	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 Design

• Study Type: Observational
• Actual Enrollment: 61 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Volumetric Analysis of Hepatocellular Carcinoma After Transarterial Chemoembolization and Its Impact on Overall Survival
• Actual Study Start Date: February 1, 2015
• Actual Primary Completion Date: December 31, 2019
• Actual Study Completion Date: December 31, 2019

Groups and Cohorts

Intervention Details:

• Procedure: 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.
  Other Name: Transarterial Chemoembolization with Drug-Eluting Beads

Outcome Measures

Primary Outcome Measures :

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 Outcome Measures :

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

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with hepatocellular carcinoma undergoing transrarterial chemoembolization

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

• Responsible Party: Monika Hajkova, Principal Investigator, Brno University Hospital
• ClinicalTrials.gov Identifier: NCT04780789
• Other Study ID Numbers: 01-080616/EK
• First Posted: March 4, 2021
• Last Update Posted: March 4, 2021
• Last Verified: March 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Monika Hajkova, Brno University Hospital:

Transarterial Chemoembolization; RECIST; mRECIST; Volumetric analysis

Additional relevant MeSH terms:

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