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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by University Health Network, Toronto.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT00963612
First received: August 7, 2009
Last updated: January 21, 2010
Last verified: January 2010

August 7, 2009
January 21, 2010
September 2009
March 2011   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT00963612 on ClinicalTrials.gov Archive Site
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 ]
Same as current
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Not Provided
 
Non-invasive Prediction of Microvascular Invasion in Hepatocellular Carcinoma by Blood-Oxygen-Level Dependent Magnetic Resonance Imaging (BOLD MRI)
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)

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.

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Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Hepatocellular Carcinoma
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.
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
March 2011
March 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Iris Zhong (416) 946-4501 ext 4816 iris.zhong@uhn.on.ca
Canada
 
NCT00963612
UHN09-0426-CE
No
Kartik Jhaveri, MD, University Health Network
University Health Network, Toronto
Not Provided
Principal Investigator: Kartik Jhaveri, MD University Health Network, Toronto
University Health Network, Toronto
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP