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

Not Applicable

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Procedure: BOLD MRI test

• Registration Number: NCT00963612
• Lead Sponsor: University Health Network, Toronto

Brief Summary

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

Not available

Study Timeline

• Study First Submitted: 2009-08-07
• Study First Submitted QC: 2009-08-19
• Study First Posted: 2009-08-21
• Study Start: 2009-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-09
• Last Update Submitted: 2017-09-28
• Last Update Posted: 2017-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single Arm	BOLD MRI test	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.

Primary Outcome Measures

Name	Time	Method
To assess the ability of BOLD MRI to predict microvascular invasion in hepatocellular carcinoma via assessment of intratumoral oxygenation.	18 months

Secondary Outcome Measures

Name	Time	Method
To identify a quantitative threshold tumor R2* value using BOLD MRI technique reasonably sensitive of predicting microvascular invasion in HCC pre-operatively.	18 months

Trial Locations

Locations (1)

University Health Network; 🇨🇦 Toronto, Ontario, Canada