NCT02878109

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2016

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 6, 2021

Status Verified

January 1, 2018

Enrollment Period

2.5 years

First QC Date

August 22, 2016

Last Update Submit

August 4, 2021

Conditions

Carcinoma, Hepatocellular

Keywords

Magnetic resonance imaging (MRI)Transarterial chemoembolization (TACE)

Outcome Measures

Primary Outcomes (2)

  • Hepatic and tumor blood flow before and 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

    Measures of hepatic and tumor blood flow will help in describing HCC angiogenesis

    Within 2 weeks before HCC treatment

Study Arms (2)

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

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

Interventions

Post-treatment phase groupDEVICE

4D-THRIVE and 4D-FLOW using magnetic resonance imaging (MRI)

Post-treatment phase group
Pre-treatment phase groupDEVICE

4D-THRIVE and 4D-FLOW using magnetic resonance imaging (MRI)

Pre-treatment phase group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre hospitalier de l'Université de Montréal

Montreal, Quebec, H2X 3E4, Canada

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Study Officials

  • An Tang, MD, MSc

    Centre hospitalier de l'Université de Montréal (CHUM)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2016

First Posted

August 25, 2016

Study Start

June 1, 2016

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

August 6, 2021

Record last verified: 2018-01

Locations

CA(1)