Value of Functional Magnetic Resonance Imaging of Hepatocellular Carcinoma After Transarterial Chemoembolization or Transarterial Radioembolization

Hepatocellular carcinoma (HCC) is one of the most common malignancies worldwide and is commonly treated with transarterial locoregional therapies (transarterial chemoembolization (TACE) or transarterial radioembolization (TARE)). Early assessment of the effectiveness of transarterial locoregional therapies is critical for treatment planning and early identification of non-responders to allow a timely repeat treatment or conversion to a second-line local-regional or systemic treatment. Response of HCC to transarterial locoregional therapies is usually assessed by changes in tumor contrast material enhancement thought to reflect tumor viability. However, contrast material enhancement may not always accurately indicate tumor response as it may also reflect reactive changes rather than residual tumor tissue. A potential alternative for evaluation of the residual tumor is diffusion-weighted imaging (DWI), which can differentiate between tumor tissue with high cellularity and tumor necrosis. DWI has been shown useful in therapy response assessment of liver tumors. A further development of DWI is intravoxel incoherent motion imaging (IVIM), an MRI technique which also takes tumor perfusion and thus tumor viability into account. This makes IVIM a promising tool for early therapy response assessment in HCC patients.

The primary objective is to proof that DWI and especially IVIM with its inherent perfusion information related to tumor neovascularization allows for reliable and quantitative monitoring of tumor response and separating responders from non-responders to either of the two locoregional treatments (TACE or TARE) The secondary objective is to identify whether DWI/IVIM acquired during early follow-up (1 month after treatment) leads to better response assessment than DWI/IVIM acquired during later follow-up (3 months after treatment).

The primary outcome will be the DWI/IVIM values in patients responding to transarterial locoregional therapies of HCC compared to patients not responding to therapy according to mRECIST at 6 months The secondary outcome will be the number of patients correctly identified as responders at early follow-up (after 1 month) with DWI/IVIM compared to the number of patients correctly identified as resopnders at later follow-up (after 3 months).

Study Overview

• Status: Terminated
• Conditions: Liver Neoplasm
• Intervention / Treatment: Diagnostic test: MRI

• Study Type: Observational
• Enrollment (Actual): 32

Contacts and Locations

Study Locations

• Switzerland
  • Zurich, Switzerland
    • University Hospital Zurich

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: Probability Sample

Study Population

Male and female patients with HCC according to imaging findings and/or histology and scheduled for TACE or TARE

Description

Inclusion Criteria:

• Informed Consent as documented by signature (Appendix Informed Consent Form)
• Male and Female patients ≥18 years of age
• Patients with HCC according to imaging findings and/or histology and scheduled for TACE or TARE

Exclusion Criteria:

• Women who are pregnant or breast feeding,
• Please note that female participants who are surgically sterilised / hysterectomised or post-menopausal for longer than 2 years are not considered as being of child bearing potential.
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant,
• Previous enrolment into the current study,
• Patients with impaired renal function (estimated glomerular filtration rate <30 ml/min)
• Patients with non-MRI compatible metallic or electronic implants, devices or metallic foreign bodies (cardiac pacemaker, shrapnel, cochlea implants, neurostimulator, or other non-MRI compatible implants).
• Tumor-directed therapy (i.e. systemic chemotherapy) between transarterial therapy and 3-months follow-up MRI exam

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
post-TAE	Diagnostic test: MRI; Baseline and follow-up MRI at 1 and 3 months post-TAE or post-TARE
post-TARE	Diagnostic test: MRI; Baseline and follow-up MRI at 1 and 3 months post-TAE or post-TARE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
DWI/IVIM values	DWI/IVIM values in patients responding to transarterial locoregional therapies of HCC compared to patients not responding to therapy according to mRECIST at 6 months	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
early responders	The secondary outcome will be the number of patients correctly identified as responders at early follow-up (after 1 month) with DWI/IVIM compared to the number of patients correctly identified as resopnders at later follow-up (after 3 months).	6 months

Collaborators and Investigators

• Sponsor: University of Zurich
• Collaborators: Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Actual): September 11, 2017
• Primary Completion (Actual): April 30, 2019
• Study Completion (Actual): April 30, 2019

Study Registration Dates

• First Submitted: January 6, 2021
• First Submitted That Met QC Criteria: January 6, 2021
• First Posted (Actual): January 8, 2021

Study Record Updates

• Last Update Posted (Actual): January 8, 2021
• Last Update Submitted That Met QC Criteria: January 6, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Carcinoma, Hepatocellular; Liver Neoplasms
• Other Study ID Numbers: BASEC ID 2016-01868

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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