Evaluation of Liver Cancer With Magnetic Resonance Imaging (MRI)
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|ClinicalTrials.gov Identifier: NCT01871545|
Recruitment Status : Recruiting
First Posted : June 6, 2013
Last Update Posted : March 8, 2018
|Condition or disease||Intervention/treatment||Phase|
|Hepatocellular Carcinoma HCC||Device: Magnetic Resonance Imaging||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||141 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of HCC Response to Systemic Therapy With Quantitative MRI|
|Study Start Date :||June 2013|
|Estimated Primary Completion Date :||January 2019|
|Estimated Study Completion Date :||January 2019|
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
- Tumor diffusion [ Time Frame: up to 5 years ]measured with diffusion-weighted imaging sequence
- Perfusion/flow [ Time Frame: up to 5 years ]measured with dynamic contrast-enhanced imaging using gadolinium contrast
- Oxygen uptake [ Time Frame: up to 5 years ]measured with T2* and T1-weighted imaging
- Stiffness [ Time Frame: up to 5 years ]measured with magnetic resonance elastography
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01871545
|Contact: Courtney Mahr, MPH, CHES||212-824-8475||Courtney.Mahr@mountsinai.org|
|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 email@example.com|
|Contact: Nikki Charles 212-824-8475 firstname.lastname@example.org|
|Principal Investigator: Bachir Taouli, MD|
|Principal Investigator:||Bachir Taouli, MD||Icahn School of Medicine at Mount Sinai|