An Investigational Scan (Magnetic Resonance Elastography) in Detecting Treatment Response in Patients With Advanced Liver Cancer

Study Overview
=================
Brief Summary
-----------------
This trial studies how well an investigational scan (magnetic resonance elastography [MRE]) works with standard imaging (magnetic resonance imaging [MRI]) in detecting response to treatment in patients with liver cancer that has spread to other places in the body. Diagnostic procedures, such as MRE with MRI, may make it easier for researchers to see if the treatment for liver cancer is working.

Detailed Description
-----------------
PRIMARY OBJECTIVE: I. To evaluate the ability of magnetic resonance (MR) elastography (MRE) to detect changes in hepatocellular carcinoma (HCC) between baseline and after initial 6 weeks of treatment (change in MRE liver tumor stiffness compared to percent non-viable/necrotic tumor). SECONDARY OBJECTIVES: I. Correlate MRE imaging measurements with patient survival (overall survival and time to tumor progression) over 18 months. II. Correlate MRE measurements with change in tumor size and enhancement on standard of care MR imaging sequences. OUTLINE: Patients undergo standard of care MRI and MRE over 30-90 minutes within 5 days of liver biopsy before receiving any medical treatment for HCC, at 6 weeks after medical treatment for HCC, and then every 12 weeks for up to 24 months.

Official Title
-----------------
Multiparametric MRI and MRE Assessment of Liver Fibrosis in Patients Treated for HCC

Conditions
-----------------
Advanced Adult Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IIIA Hepatocellular Carcinoma AJCC v8, Stage IIIB Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Stage IVA Hepatocellular Carcinoma AJCC v8, Stage IVB Hepatocellular Carcinoma AJCC v8

Intervention / Treatment
-----------------
* Procedure: Magnetic Resonance Elastography
* Procedure: Magnetic Resonance Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Liver cancer. Available tumor and liver parenchyma tissue (biopsy-proven HCC). No contraindications to MRI (such implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental MRI screening form. Able to undergo informed consent. Not pregnant. Exclusion Criteria: Contraindication to MRI (including cardiac pacemaker; ferromagnetic foreign objects in the patient; metallic eye fragments; claustrophobia). Inability to comply with study and/or follow-up procedures.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diagnostic (MRI/MRE)<br>Patients undergo standard of care MRI and MRE over 30-90 minutes within 5 days of liver biopsy before receiving any medical treatment for HCC, at 6 weeks after medical treatment for HCC, and then every 12 weeks for up to 24 months. | Procedure: Magnetic Resonance Elastography<br>* Undergo multiparametric MRI/MRE<br>* Other names: MRE;Procedure: Magnetic Resonance Imaging<br>* Undergo multiparametric MRI/MRE<br>* Other names: Nuclear Magnetic Resonance Imaging;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in magnetic resonance elastography (MRE) liver tumor stiffness | Imaging measurements and percent necrosis will be summarized using mean, standard deviation (SD), and range. Pearson correlation coefficient will be estimated between imaging measurements and percent necrosis. | Baseline to 6 weeks | 
| Change in percent non-viable/necrotic tumor | Will be determined by pathologists using follow-up biopsy/surgery samples. Imaging measurements and percent necrosis will be summarized using mean, SD, and range. Pearson correlation coefficient will be estimated between imaging measurements and percent necrosis. | Baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Cox proportional hazard model will be used to correlate imaging measurements with survival endpoints. | 18 months | 
| Time to tumor progression | Logistic regression model will be used to correlate imaging measurements with response status. | 18 months | 
| Change in tumor size and enhancement | Will correlate MRE measurements with change in tumor size and enhancement on standard of care MR imaging sequences. Linear mixed model will be used to correlate MRE imaging measurements with other tumor characteristics (e.g. size, etc.). | Baseline to 18 months |