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

Not Applicable

Recruiting

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

Interventions: Procedure: Magnetic Resonance Elastography
Procedure: Magnetic Resonance Imaging

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Diagnostic (MRI/MRE)	Magnetic Resonance Elastography	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.
Diagnostic (MRI/MRE)	Magnetic Resonance Imaging	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.

Primary Outcome Measures

Name	Time	Method
Change in magnetic resonance elastography (MRE) liver tumor stiffness	Baseline to 6 weeks	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.
Change in percent non-viable/necrotic tumor	Baseline to 6 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Overall survival	18 months	Cox proportional hazard model will be used to correlate imaging measurements with survival endpoints.
Change in tumor size and enhancement	Baseline to 18 months	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.).
Time to tumor progression	18 months	Logistic regression model will be used to correlate imaging measurements with response status.