Evaluation of Liver Cancer With Magnetic Resonance Imaging (MRI)

NCT ID: NCT01871545

Last Updated: 2020-07-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2018-02-02

Brief 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.

Detailed 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.

Conditions

Hepatocellular Carcinoma; HCC

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Magnetic Resonance Imaging

dynamic contrast-enhanced MRI measuring arterial and portal flow

Group Type: EXPERIMENTAL

Magnetic Resonance Imaging

Intervention Type: DEVICE

Magnetic Resonance Imaging is a radiation free non invasive technique using magnetic radiofrequency waves to image the body. In this study, the research team would like to investigate the possibility of providing functional information on aggressiveness, vascularity and oxygen uptake in liver cancer tumors.

Healthy Controls

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Magnetic Resonance Imaging

Magnetic Resonance Imaging is a radiation free non invasive technique using magnetic radiofrequency waves to image the body. In this study, the research team would like to investigate the possibility of providing functional information on aggressiveness, vascularity and oxygen uptake in liver cancer tumors.

Intervention Type: DEVICE

Other Intervention Names

MRI

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Icahn School of Medicine at Mount Sinai

OTHER

Sponsor Role: lead

Responsible Party

Bachir Taouli

Professor, Radiology and Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bachir Taouli, MD

Role: PRINCIPAL_INVESTIGATOR

Icahn School of Medicine at Mount Sinai

Locations

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

GCO 12-0214

Identifier Type: -

Identifier Source: org_study_id