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

This study is currently recruiting participants. (see Contacts and Locations)

Verified March 2016 by University Health Network, Toronto

Sponsor:

Information provided by (Responsible Party):

University Health Network, Toronto

ClinicalTrials.gov Identifier:

NCT00963612

First received: August 7, 2009

Last updated: March 4, 2016

Last verified: March 2016

History of Changes

Purpose

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	Intervention
Hepatocellular Carcinoma	Procedure: BOLD MRI test


Study Type:	Interventional
Study Design:	Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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)

Resource links provided by NLM:

MedlinePlus related topics: Diagnostic Imaging MRI Scans Oxygen Therapy

Genetic and Rare Diseases Information Center resources: Liver Cancer

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]


Estimated Enrollment:	80
Study Start Date:	September 2009
Estimated Study Completion Date:	December 2016
Estimated Primary Completion Date:	December 2016 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00963612

Contacts


Contact: Nima Sadoughi		Nima.Sadoughi@uhn.ca
Contact: Hooman Hosseini-Nik		Hooman.Hosseini-Nik@uhn.ca

Locations


Canada, Ontario
University Health Network	Recruiting
Toronto, Ontario, Canada, M5G 2M9
Contact: Nima Sadoughi Nima.Sadoughi@uhn.ca
Contact: Hooman Hosseini-Nik Hooman.Hosseini-Nik@uhn.ca

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
Study First Received:	August 7, 2009
Last Updated:	March 4, 2016
Health Authority:	Canada: Health Canada

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

ClinicalTrials.gov processed this record on September 27, 2016

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