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Evaluation of HCC Response to Systemic Therapy With Quantitative MRI

18 Years
Open (Enrolling)
Hepatocellular Carcinoma, HCC

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Trial Information

Evaluation of HCC Response to Systemic Therapy With Quantitative MRI

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.

Inclusion Criteria:

Study group

- Patients diagnosed with HCC, who will undergo resection or transplantation within 6
months, 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 Criteria:

- Age less than 18 years

- Unable or unwilling to give informed consent

- Contra-indications to MRI:

1. Electrical implants such as cardiac pacemakers or perfusion pumps

2. Ferromagnetic implants such as aneurysm clips, surgical clips, prostheses,
artificial hearts, valves with steel parts, metal fragments, shrapnel, tattoos
near the eye, or steel implants

3. Ferromagnetic objects such as jewelry or metal clips in clothing

4. Pregnant subjects

5. Pre-existing medical conditions including a likelihood of developing seizures or
claustrophobic reactions

Type of Study:


Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

Tumor diffusion

Outcome Description:

measured with diffusion-weighted imaging sequence

Outcome Time Frame:

up to 5 years

Safety Issue:


Principal Investigator

Bachir Taouli, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Icahn School of Medicine at Mount Sinai


United States: Institutional Review Board

Study ID:

GCO 12-0214



Start Date:

June 2013

Completion Date:

January 2018

Related Keywords:

  • Hepatocellular Carcinoma
  • HCC
  • hepatocellular carcinoma
  • HCC
  • liver cancer
  • liver disease
  • magnetic resonance imaging
  • MRI
  • Carcinoma
  • Liver Neoplasms
  • Carcinoma, Hepatocellular



Icahn School of Medicine at Mount Sinai New York, New York  10029