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

M.D. Anderson Cancer Center6 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Advanced Adult Hepatocellular Carcinoma Stage III Hepatocellular Carcinoma AJCC v8

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Baseline to 6 weeks

Secondary Outcomes

Overall survival

Cox proportional hazard model will be used to correlate imaging measurements with survival endpoints.

Time frame: 18 months

Time to tumor progression

Logistic regression model will be used to correlate imaging measurements with response status.

Time frame: 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.).

Time frame: Baseline to 18 months