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

NCT ID: NCT04702230

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 32 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-09-11
• Study Completion Date: 2019-04-30

Brief Summary

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).

Conditions

Liver Neoplasm

Study Design

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

Study Groups

post-TAE

MRI

Intervention Type: DIAGNOSTIC_TEST

Baseline and follow-up MRI at 1 and 3 months post-TAE or post-TARE

post-TARE

MRI

Intervention Type: DIAGNOSTIC_TEST

Baseline and follow-up MRI at 1 and 3 months post-TAE or post-TARE

Interventions

MRI

Baseline and follow-up MRI at 1 and 3 months post-TAE or post-TARE

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

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

Sponsors

Centre Hospitalier Universitaire Vaudois

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Caecilia Reiner

Staff Radiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital Zurich

Zurich, , Switzerland

Countries

Switzerland

Other Identifiers

BASEC ID 2016-01868

Identifier Type: -

Identifier Source: org_study_id