DCE-MRI for Assessment of Response to TACE of HCC (DCE-MRI)

August 4, 2021 updated by: Centre hospitalier de l'Université de Montréal (CHUM)

Dynamic Contrast-enhanced Magnetic Resonance Imaging for Assessment of Response to Transarterial Chemoembolization of Hepatocellular Carcinoma

This study is conducted to evaluate dynamic contrast-enhanced MRI to quantify the efficacy of trans-arterial chemoembolization by comparing imaging results before and after treatment for at least one hepatic tumor and to look at blow flow curves of the free-breathing MRI before treatment.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Background: Liver cancer is the second leading cause of cancer deaths worldwide. Hepatocellular carcinoma (HCC) typically presents arterial phase hyperenhancement. For intermediate stage disease and the majority of patients not eligible for curative therapies, transarterial chemoembolization (TACE) is considered as the first-line palliative treatment in eligible patients.

Despite its efficacy on HCC, TACE presents major challenges such as the lack of quantitative biomarkers of treatment response. Dynamic contrast-enhanced MRI (DCE-MRI) enables quantitative assessment of tumor and tissue enhancement, by acquiring MR signal intensity as a function of time.

Objectives: This study is conducted: 1) to develop a monitoring system based on quantifiable measures during intra-arterial treatments from dynamic MRI, using time-activity curves analyzed using a dual-input dual-compartment model, and 2) to look at blood flow curves of the MRI before the treatment, if any, for at least one tumor, without requiring any breath hold.

Design:

  • Post-treatment phase group: This will be a prospective study in HCC patients undergoing TACE (including DC beads) according to their clinical standard of care. A 4D-THRIVE sequence will be performed. Single intensities before/after gadolinium-based contrast agent enhancement will be used to create time-concentration curves, which will be fitted to a simple perfusion model that accounts for the dual blood supply of the liver through the hepatic artery and the portal vein. Perfusion parameters of arterial hepatic blood flow, portal venous hepatic blood flow, total hepatic blood flow and arterial fraction will be extracted from the model and compared between HCC and surrounding cirrhotic liver. When deemed necessary, a CBCT can be acquired before chemo-embolization in way to see that the appropriate artery is selected for the treatment. The CBCT will be used when available to determine the parameters of the blood flow obtained with our model.
  • Pre-treatment phase group: This will be a prospective study in HCC patients undergoing a MRI according to their clinical standard of care. A 4D-THRIVE sequence will be performed. Single intensities before/after gadolinium-based contrast agent enhancement will be used to create time-concentration curves, which will be fitted to a simple perfusion model that accounts for the dual blood supply of the liver through the hepatic artery and the portal vein. Perfusion parameters of arterial hepatic blood flow, portal venous hepatic blood flow, total hepatic blood flow and arterial fraction will be extracted from the model and compared between HCC and surrounding cirrhotic liver.
  • Comparison: A comparison between the blood flow curves between the post-treatment phase group [apnea] and the pre-treatment phase group [free-breathing] will be done.

Methods: Forty patients will be selected. For twenty-nine of them [post-treatment phase group], a 4D-THRIVE sequence will be acquired within 2 weeks prior to TACE and between 6 and 8 weeks after TACE. A 4D-FLOW MRI sequence will also be included. For the remaining eleven patients [pre-treatment phase group], only a 4D-THRIVE sequence will be acquired within 2 weeks prior to treatment, if any, including a 4D-FLOW MRI sequence.

Expected results: The results of this study will provide quantitative DCE-MRI biomarkers for identification of viable tumor and tumor response. In addition, presence of increased % arterial flow and decreased portal venous flow in HCC using DCE-MRI are expected to help to assess treatment response.

Study Type

Observational

Enrollment (Actual)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H2X 3E4
        • Centre Hospitalier de l'Universite de Montreal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

The target population is adults with a hepatocellular carcinoma (HCC). The post-treatment phase group will also encompass patients with a planned transarterial chemoembolization (TACE). For the purpose of this study, the investigators will recruit patients who will be treated at the CHUM.

Description

Inclusion Criteria:

  • All patients:

    • Are at least 18 years old at screening;
    • Able to comprehend and willingness to provide voluntary consent;
    • Have at least one HCC;
    • HCC lesion of at least 10 mm;
    • Understand French or English instruction.

  • Post-treament phase group:

    • Are able to have a MRI before and after TACE;
    • Must undergo a TACE as part of their clinical standard of care for HCC;
    • Have a new prescription for TACE for at least one HCC.

  • Pre-treatment phase group:

    • Are able to have a MRI before treatment (if any);
    • Must undergo an MRI as part of their clinical standard of care for HCC.

Exclusion Criteria:

  • Have any contra-indication for MRI (such as claustrophobia, pacemaker, metallic clips for a neurosurgical procedure);
  • Are pregnant or trying to become pregnant;
  • Have a weight or girth preventing them from entering the MR magnet bore;
  • Are unable to understand or unwilling to provide written informed consent for this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Post-treatment phase group
29 patients will undergo: 4D-THRIVE and 4D-FLOW sequences during magnetic resonance imaging (MRI) before and after transarterial chemoembolisation (TACE).
Device: Post-treatment phase group
4D-THRIVE and 4D-FLOW using magnetic resonance imaging (MRI)
Pre-treatment phase group
11 patients will undergo: 4D-THRIVE and 4D-FLOW sequences during magnetic resonance imaging (MRI) before treatment (if any).
Device: Pre-treatment phase group
4D-THRIVE and 4D-FLOW using magnetic resonance imaging (MRI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hepatic and tumor blood flow before and after TACE
Time Frame: Within 2 weeks before TACE and 6 to 8 weeks after TACE
Measures of hepatic and tumor blood flow will help in describing HCC angiogenesis and in determining the efficiency of TACE on the tumor.
Within 2 weeks before TACE and 6 to 8 weeks after TACE
Hepatic and tumor blood flow before HCC treatment
Time Frame: Within 2 weeks before HCC treatment
Measures of hepatic and tumor blood flow will help in describing HCC angiogenesis
Within 2 weeks before HCC treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centre hospitalier de l'Université de Montréal (CHUM)

Collaborators

Canadian Institutes of Health Research (CIHR)
Centre de Recherche du Centre Hospitalier de l'Université de Montréal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2016

Primary Completion (Actual)

December 1, 2018

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

August 22, 2016

First Submitted That Met QC Criteria

August 22, 2016

First Posted (Estimate)

August 25, 2016

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE15.388

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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