Non-invasive Prediction of Microvascular Invasion in Hepatocellular Carcinoma by Blood-Oxygen-Level Dependent Magnetic Resonance Imaging (BOLD MRI)
|ClinicalTrials.gov Identifier: NCT00963612|
Recruitment Status : Completed
First Posted : August 21, 2009
Last Update Posted : October 2, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma||Procedure: BOLD MRI test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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)|
|Study Start Date :||September 2009|
|Actual Primary Completion Date :||December 2016|
|Actual Study Completion Date :||December 2016|
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
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.
- To assess the ability of BOLD MRI to predict microvascular invasion in hepatocellular carcinoma via assessment of intratumoral oxygenation. [ Time Frame: 18 months ]
- To identify a quantitative threshold tumor R2* value using BOLD MRI technique reasonably sensitive of predicting microvascular invasion in HCC pre-operatively. [ Time Frame: 18 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963612
|University Health Network|
|Toronto, Ontario, Canada, M5G 2M9|
|Principal Investigator:||Kartik Jhaveri, MD||University Health Network, Toronto|