Evaluation of Liver Cancer With Magnetic Resonance Imaging (MRI)

Phase

N/A

Condition

Digestive System Neoplasms

Abdominal Cancer

Liver Disease

Treatment

N/A

Clinical Study ID

NCT01871545

GCO 12-0214

Ages > 18
All Genders
Accepts Healthy Volunteers

Study Summary

The incidence of hepatocellular carcinoma (HCC) has recently increased in the United States. Although imaging plays a major role in HCC screening and staging, the possibility of predicting HCC tumor grade, aggressiveness, angiogenesis and hypoxia with imaging are unmet needs. In addition, new antiangiogenic drugs now available to treat advanced HCC necessitate the use of new imaging criteria beyond size. The investigators would like to develop and validate non-invasive magnetic resonance imaging (MRI) methods based on advanced diffusion-weighted imaging (DWI), MR Elastography, BOLD (blood oxygen level dependent) MRI and perfusion-weighted imaging (PWI, using gadolinium contrast) to be used as non-invasive markers of major histopathologic features of HCC, and to predict and assess early response of HCC to systemic therapy. The investigators also would like to develop quality control tools to improve the quality and decrease variability of quantitative MRI metrics. These techniques combined could represent non-invasive correlates of histologic findings in HCC, could enable individualized therapy, and provide prognosis in patients with HCC.

Eligibility Criteria

Inclusion

Inclusion Criteria: Study group

Patients diagnosed with HCC, who will undergo resection or transplantation within 6months, as part of routine clinical care and patients diagnosed with unresectable HCC
18 years of age and older
Patient is able to give informed consent for this study Control group
Healthy volunteers 18 years of age and older
Subject is able to give informed consent for this study

Exclusion

Exclusion Criteria:

Age less than 18 years
Unable or unwilling to give informed consent
Contra-indications to MRI:

Electrical implants such as cardiac pacemakers or perfusion pumps
Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses,artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoosnear the eye, or steel implants
Ferromagnetic objects such as jewelry or metal clips in clothing
Pregnant subjects
Pre-existing medical conditions including a likelihood of developing seizures orclaustrophobic reactions

Study Design

June 01, 2013

February 02, 2018

Study Description

The incidence of hepatocellular carcinoma (HCC) has recently increased in the US mostly due to an increase in chronic hepatitis C infection. Angiogenesis is critical for the growth and metastatic progression of HCC. With the development of new antiangiogenic drugs such as sorafenib, imaging methods to predict and assess therapeutic response beyond changes in size become critical. However, validated imaging methods to predict and assess early HCC response to targeted agents are lacking.

In this study, the investigators would like to develop quantitative MRI methods interrogating different features of HCC tumor biology and pathology, including tumor cellularity, grade, angiogenesis and hypoxia. The investigators propose a multiparametric approach combining advanced DWI (IVIM: intravoxel incoherent motion diffusion measuring perfusion fraction and true diffusion coefficient), DCE-MRI (dynamic contrast-enhanced MRI, which measures arterial and portal flow, mean transit time, blood volume and distribution volume), and BOLD MRI using oxygen or carbogen challenge. This protocol will be performed in patients with HCC undergoing hepatic resection. Routine and advanced histopathologic methods will be performed (tumor grade, CK19 expression, presence of microvascular invasion, VEGF expression, microvessel density, HIF 1-alpha expression). MRI metrics will be correlated with histopathologic metrics.

The first portion of the proposal involves the development of a QC algorithm assessing MR data quality and test-retest. The investigators will propose solutions to improve data acquisition and processing. The last 2 years of the study will be dedicated to a prospective randomized study comparing Yttrium 90 radioembolization to sorafenib, assessing the role of baseline MRI metrics and early changes (at 2 weeks) in these metrics as markers of tumor response and time to progression in patients with unresectable HCC.

Connect with a study center

Icahn School of Medicine at Mount Sinai
New York, New York 11103
United States
Site Not Available

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