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

Study Overview
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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.

Official Title
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Non-Invasive Prediction of Microvascular Invasion (MVI) in Hepatocellular Carcinoma (HCC) by Assessment of Tumor Oxygenation by Blood Oxygen Level-Dependent Magnetic Resonance Imaging (BOLD MRI)

Conditions
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Hepatocellular Carcinoma

Intervention / Treatment
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* Procedure: BOLD MRI test


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single Arm<br>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. | Procedure: BOLD MRI test<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the ability of BOLD MRI to predict microvascular invasion in hepatocellular carcinoma via assessment of intratumoral oxygenation. |  | 18 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microvascular Invasion, Blood-Oxygen-Level Dependent Magnetic Resonance Imaging (BOLD MRI)