Evaluation of Liver Cancer With Magnetic Resonance Imaging (MRI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Mount Sinai School of Medicine
Sponsor:
Information provided by (Responsible Party):
Bachir Taouli, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier:
NCT01871545
First received: June 4, 2013
Last updated: December 16, 2013
Last verified: December 2013
  Purpose

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.


Condition Intervention
Hepatocellular Carcinoma
HCC
Device: Magnetic Resonance Imaging

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of HCC Response to Systemic Therapy With Quantitative MRI

Resource links provided by NLM:


Further study details as provided by Mount Sinai School of Medicine:

Primary Outcome Measures:
  • Tumor diffusion [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    measured with diffusion-weighted imaging sequence

  • Perfusion/flow [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    measured with dynamic contrast-enhanced imaging using gadolinium contrast

  • Oxygen uptake [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    measured with T2* and T1-weighted imaging

  • Stiffness [ Time Frame: up to 5 years ] [ Designated as safety issue: No ]
    measured with magnetic resonance elastography


Estimated Enrollment: 141
Study Start Date: June 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Magnetic Resonance Imaging
dynamic contrast-enhanced MRI measuring arterial and portal flow
Device: 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.
Other Name: MRI

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01871545

Contacts
Contact: Claudia Donnerhack 212-824-8475 claudia.donnerhack@mountsinai.org

Locations
United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 11103
Contact: Bachir Taouli, MD    212-824-8475    bachir.taouli@mountsinai.org   
Contact: Claudia Donnerhack, MS    212-824-8475    claudia.donnerhack@mountsinai.org   
Principal Investigator: Bachir Taouli, MD         
Sponsors and Collaborators
Mount Sinai School of Medicine
Investigators
Principal Investigator: Bachir Taouli, MD Mount Sinai School of Medicine
  More Information

No publications provided

Responsible Party: Bachir Taouli, Professor, Radiology and Medicine, Mount Sinai School of Medicine
ClinicalTrials.gov Identifier: NCT01871545     History of Changes
Other Study ID Numbers: GCO 12-0214
Study First Received: June 4, 2013
Last Updated: December 16, 2013
Health Authority: United States: Institutional Review Board
United States: Food and Drug Administration

Keywords provided by Mount Sinai School of Medicine:
hepatocellular carcinoma
HCC
liver cancer
liver disease
magnetic resonance imaging
MRI

Additional relevant MeSH terms:
Carcinoma
Carcinoma, Hepatocellular
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Adenocarcinoma
Liver Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Liver Diseases

ClinicalTrials.gov processed this record on September 18, 2014