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

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ClinicalTrials.gov Identifier: NCT00963612

Recruitment Status : Completed

First Posted : August 21, 2009

Last Update Posted : October 2, 2017

Sponsor:

Information provided by (Responsible Party):

University Health Network, Toronto

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.

Condition or disease	Intervention/treatment	Phase
Hepatocellular Carcinoma	Procedure: BOLD MRI test	Not Applicable

Study Design


Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	80 participants
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: MRI Scans Oxygen Therapy

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
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.	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.

Outcome Measures

Primary Outcome Measures :

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 Measures :

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 ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00963612

Locations


Canada, Ontario
University Health Network
Toronto, Ontario, Canada, M5G 2M9

Sponsors and Collaborators

University Health Network, Toronto

Investigators


Principal Investigator:	Kartik Jhaveri, MD	University Health Network, Toronto

More Information


Responsible Party:	University Health Network, Toronto
ClinicalTrials.gov Identifier:	NCT00963612 History of Changes
Other Study ID Numbers:	UHN09-0426-CE
First Posted:	August 21, 2009 Key Record Dates
Last Update Posted:	October 2, 2017
Last Verified:	September 2017

Keywords provided by University Health Network, Toronto:


Microvascular Invasion Blood-Oxygen-Level Dependent Magnetic Resonance Imaging (BOLD MRI)

Additional relevant MeSH terms:


Carcinoma Carcinoma, Hepatocellular Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Adenocarcinoma	Liver Neoplasms Digestive System Neoplasms Neoplasms by Site Digestive System Diseases Liver Diseases

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