Non-invasive Prediction of Microvascular Invasion in Hepatocellular Carcinoma by Blood-Oxygen-Level Dependent Magnetic Resonance Imaging (BOLD MRI)
Primary Purpose
Hepatocellular Carcinoma
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
BOLD MRI test
Sponsored by
About this trial
This is an interventional diagnostic trial for Hepatocellular Carcinoma focused on measuring Microvascular Invasion, Blood-Oxygen-Level Dependent Magnetic Resonance Imaging (BOLD MRI)
Eligibility Criteria
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.
Sites / Locations
- University Health Network
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Single Arm
Arm Description
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.
Outcomes
Primary Outcome Measures
To assess the ability of BOLD MRI to predict microvascular invasion in hepatocellular carcinoma via assessment of intratumoral oxygenation.
Secondary Outcome Measures
To identify a quantitative threshold tumor R2* value using BOLD MRI technique reasonably sensitive of predicting microvascular invasion in HCC pre-operatively.
Full Information
NCT ID
NCT00963612
First Posted
August 7, 2009
Last Updated
September 28, 2017
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT00963612
Brief Title
Non-invasive Prediction of Microvascular Invasion in Hepatocellular Carcinoma by Blood-Oxygen-Level Dependent Magnetic Resonance Imaging (BOLD MRI)
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 Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatocellular Carcinoma
Keywords
Microvascular Invasion, Blood-Oxygen-Level Dependent Magnetic Resonance Imaging (BOLD MRI)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
80 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Single Arm
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
BOLD MRI test
Intervention Description
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.
Primary Outcome Measure Information:
Title
To assess the ability of BOLD MRI to predict microvascular invasion in hepatocellular carcinoma via assessment of intratumoral oxygenation.
Time Frame
18 months
Secondary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kartik Jhaveri, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Non-invasive Prediction of Microvascular Invasion in Hepatocellular Carcinoma by Blood-Oxygen-Level Dependent Magnetic Resonance Imaging (BOLD MRI)
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