Evaluation of Liver Cancer With Magnetic Resonance Imaging (MRI)

NCT01871545 | Completed Results DMC

• 1 other identifier: GCO 12-0214
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma; HCC

Keywords

hepatocellular carcinoma; HCC; liver cancer; liver disease; magnetic resonance imaging; MRI

Outcome Measures

Primary Outcomes (11)

• SubStudy 1: Apparent Diffusion Coefficient (ADC)

  Tumor diffusion (apparent diffusion coefficient) measured with diffusion-weighted imaging sequence

  Day 1

• SubStudy 1: Total Tumor Perfusion (Ft)

  Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast

  Day 1

• SubStudy 1: Tumor Arterial Perfusion Fraction (ART)

  Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast

  Day 1

• SubStudy 1: Tumor Mean Transit Time (MTT)

  Tumor mean transit time (MTT) of contrast agent. Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast

  Day 1

• SubStudy 1: Tumor Distribution Volume (DV)

  Tumor distribution volume (DV) of contrast agent. Perfusion/flow measured with dynamic contrast-enhanced imaging using gadolinium contrast

  Day 1

• SubStudy 1: Oxygen Uptake

  Oxygen uptake measured with T2\* and T1-weighted imaging

  Day 1

• SubStudy 1: Percent Change in Oxygen Uptake

  Oxygen uptake measured with T2\* and T1-weighted imaging. Oxygen uptake (% change pre and post O2 administration) calculated by Liver ΔR2\*=100 x (R2\* post O2-R2\* pre O2)/R2\* pre O2. The healthy participants breathed 100% medical O2 through a mask for 10 min., and were imaged before and after O2 administration with the MRI methods that are sensitive to oxygen uptake in tumors.

  Day 1, pre-oxygen administration and 10 min. post-oxygen administration

• SubStudy 2: ADC

  Tumor diffusion measured with diffusion-weighted imaging sequence. In diffusion weighted MR imaging (DWI), the signal is proportional to the Brownian motion diffusion of free water protons in tissues. Deposition of collagen in tissue (as in fibrotic disease), or cellularity in tumors act as impediments to free water diffusion. Using different mathematical models, the degree of diffusion can be quantified from the MRI signal, to provide information on diffusion restriction due to disease. From mono exponential fit of diffusion signal, one can obtain the apparent diffusion coefficient (ADC). However, this coefficient reflects free water proton diffusion, as well as transport of water protons in the capillary vessels (capillary perfusion).

  baseline and 6 weeks after Y90

• SubStudy 2: Diffusion Coefficient D

  Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the true diffusion coefficient D, reflecting free water proton diffusion.

  baseline and 6 weeks after Y90

• SubStudy 2: Pseudodiffusion Coefficient D*

  Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the pseudo-diffusion coefficient D\*, affected by free diffusion and capillary perfusion.

  baseline and 6 weeks after Y90

• SubStudy 2: Perfusion Fraction (PF)

  Tumor diffusion measured with diffusion-weighted imaging sequence. To separate the diffusion effect from capillary perfusion, a bi-exponential model is used, which provides 3 coefficients: one is the perfusion fraction PF, which reflects how much the diffusion-weighted signal is affected by capillary perfusion. PF is a measure of vascularity in the tissue.

  baseline and 6 weeks after Y90

Secondary Outcomes (6)

• SubStudy 2: Total Tumor Perfusion (Ft)

  baseline and 6 weeks after Y90

• SubStudy 2: Tumor Arterial Perfusion Fraction (ART)

  baseline and 6 weeks after Y90

• SubStudy 2: Tumor Mean Transit Time (MTT) of Contrast Agent

  baseline and 6 weeks after Y90

• SubStudy 2: Extravascular Extracellular Volume ve

  baseline and 6 weeks after Y90

• Substudy 2: Tumor Stiffness

  baseline and 6 weeks after Y90

Study Arms (2)

Magnetic Resonance Imaging

EXPERIMENTAL

dynamic contrast-enhanced MRI measuring arterial and portal flow

Device: Magnetic Resonance Imaging

Healthy Controls

NO INTERVENTION

Interventions

Magnetic Resonance Imaging 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.

Also known as: MRI

Magnetic Resonance Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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, tattoos near 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 or claustrophobic reactions

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 11103, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Liver Neoplasms; Liver Diseases

Interventions

Magnetic Resonance Imaging

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Dr. Bachir Taouli
• Organization: Icahn School of Medicine at Mount Sinai

bachir.taouli@mountsinai.org

212-824-8475

Study Officials

• Bachir Taouli, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Radiology and Medicine

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 6, 2013
• Study Start: June 1, 2013
• Primary Completion: February 2, 2018
• Study Completion: February 2, 2018
• Last Updated: July 9, 2020
• Results First Posted: July 9, 2020

Record last verified: 2020-06

Locations

US (1)