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Non-invasive Prediction of Microvascular Invasion in Hepatocellular Carcinoma by Blood-Oxygen-Level Dependent Magnetic Resonance Imaging (BOLD MRI)

NCT ID: NCT00963612

Last Updated: 2017-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2016-12-31

Brief Summary

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Liver resection and liver transplantation are the acceptable treatment of Hepatocellular Carcinoma (HCC). But the long-term survival is unsatisfactory as a result of high rate of intra and extra hepatic recurrences. Microvascular invasion (MVI) is the most significant risk factor affecting recurrence-free survival in patients following liver resection and liver transplantation. Tumor hypoxia (lack of adequate blood supply) is the single most important factor that predict MVI and post surgical prognosis.

Blood Oxygen Level Dependent (BOLD) MRI is a non-invasive diagnostic method of assessing tumor hypoxia by detecting signal changes secondary to changes in blood flow and oxygenation. BOLD MRI assessment of tumor hypoxia in HCC has never been correlated with pathological confirmation of MVI, the gold standard to assess MVI in HCC. In this study, the investigators propose to assess the ability of BOLD MRI to provide a discriminating quantitative threshold of intratumoral oxygenation predictive of MVI.

Detailed Description

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Conditions

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Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Single Arm

In this project, there is only one study group which comprises of patients with Hepatocellular Carcinoma (HCC) who will undergo "Liver BOLD-MRI" before hepatic resection.

Group Type OTHER

BOLD MRI test

Intervention Type PROCEDURE

Additional MR pulse sequence performed on BOLD MRI is expected to increase the regular scan time by an additional 5-10 minutes. No intravenous contrast is required for BOLD acquisition.

Interventions

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BOLD MRI test

Additional MR pulse sequence performed on BOLD MRI is expected to increase the regular scan time by an additional 5-10 minutes. No intravenous contrast is required for BOLD acquisition.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Patients with known Hepatocellular Carcinoma;
* Scheduled to undergo liver resection or liver transplantation.

Exclusion Criteria

* Estimated GFR (eGFR \< 30 mL/min;
* MRI contrast allergy;
* General contraindications to MRI such as pacemaker, etc.;
* Prior tumor treatment such as transarterial chemoembolization or the tumor or radiofrequency ablation or chemoradiation;
* Pregnancy;
* Age less than 18 years.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kartik Jhaveri, MD

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Locations

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University Health Network

Toronto, Ontario, Canada

Site Status

Countries

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Canada

Other Identifiers

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UHN09-0426-CE

Identifier Type: -

Identifier Source: org_study_id