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NCT Number: NCT00963612

Non-invasive Prediction of Microvascular Invasion in Hepatocellular Carcinoma 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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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Network

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

BOLD MRI test

Procedure

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 outcomes

  1. To assess the ability of BOLD MRI to predict microvascular invasion in hepatocellular carcinoma via assessment of intratumoral oxygenation.

    Time frame: 18 months

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2016
Study completion
2016
First posted
Aug 21, 2009
Registry last updated
Oct 2, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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