NCT02051283

Brief Summary

HCC is classified as keratin (K) 19 positive or K19 negative. K19 is a biliary/hepatic progenitor cell (HPC) marker only expressed in a subset of HCC with poor prognosis and high risk of early recurrence after treatment; particularly in radio-frequency ablation (RFA). These patients consequently show worse survival compared to patients with K19 negative HCC. A recent publication has shown the value of pretreatment biopsy with K19 staining and suggests that the role of routine biopsies in potentially curable HCC should be reconsidered. However, currently, pretreatment biopsies are rarely performed in the diagnosis of HCC due to the excellent performance of magnetic resonance imaging (MRI) in detection, diagnosis and staging of cirrhotic livers. Previous publications have indicated imaging patterns that may be associated with worse prognostic tumoral parameters. If MRI determined imaging parameters could indeed provide a surrogate marker for presence of K19 and/or microvascular invasion as potential important prognostic factors in RFA of HCC, these imaging parameters may thus hold prognostic information towards RFA treatment and possibly predict treatment outcome. . The purpose of the retrospective study is thus to evaluate MRI determined imaging parameters at pretreatment MRI for their predictive value towards outcome (disease free survival) of radio-frequency ablation for hepatocellular carcinoma. If successful, pretreatment MRI parameters may be used for selecting patient with high risk of unfavorable outcome after RFA and select the patients for more aggressive treatment such as surgical resection or upfront transplantation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

January 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

February 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

January 31, 2014

Status Verified

January 1, 2014

Enrollment Period

2.8 years

First QC Date

January 29, 2014

Last Update Submit

January 29, 2014

Conditions

Hepatocellular Carcinoma

Keywords

Hepatocellular carcinomaRFAMRI

Outcome Measures

Primary Outcomes (1)

  • Predictive value of MRI determined contrast-enhanced and diffusion-weighted sequence pattern towards outcome (tumour recurrence < 1 year versus > 1 year)

    Predictive value of MRI determined contrast-enhanced and diffusion-weighted sequence pattern towards outcome (tumour recurrence \< 1 year versus \> 1 year)

    2 years

Secondary Outcomes (1)

  • Correlation of predictive MRI parameters with histology obtained from biopsy during radio-frequency ablation (tumor grade, microvascular invasion, Keratin 19 status)

    2 years

Study Arms (1)

patients with HCC eligible for RFA

patients with HCC eligible for RFA

Other: RFA

Interventions

RFAOTHER

RFA

patients with HCC eligible for RFA

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

* Documented and diagnosed liver confined hepatocellular carcinoma by existing imaging criteria according to currently accepted international guidelines (\< 4cm). * Treatment radio-frequency ablation - (percutaneous, laparascopy, laparatomy) * Availability of pretreatment MRI with three phase contrast enhanced images and diffusion-weighted sequence prior to treatment. * Follow-up of at least 2 years.

You may qualify if:

  • Documented and diagnosed liver confined hepatocellular carcinoma by existing imaging criteria according to currently accepted international guidelines (\< 4cm).
  • Treatment radio-frequency ablation - (percutaneous, laparascopy, laparatomy)
  • Availability of pretreatment MRI with three phase contrast enhanced images and diffusion-weighted sequence prior to treatment.
  • Follow-up of at least 2 years.

You may not qualify if:

  • Non availability of pathologic confirmation or biopsy during radio-frequency ablation.
  • Post-treatment follow-up \< 2 years.
  • Treatment other than RFA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospitals UZ Leuven, Gasthuisberg

Leuven, Vlaams-Brabant, 3000, Belgium

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 Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 29, 2014

First Posted

January 31, 2014

Study Start

February 1, 2014

Primary Completion

December 1, 2016

Study Completion

December 1, 2016

Last Updated

January 31, 2014

Record last verified: 2014-01

Locations

BE(1)