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

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.

• Magnetic Resonance Elastography (Procedure), also known as MRE: Undergo multiparametric MRI/MRE
• Magnetic Resonance Imaging (Procedure), also known as Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging: Undergo multiparametric MRI/MRE

Primary outcomes

• 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 outcomes

• Overall survival [18 months]: Cox proportional hazard model will be used to correlate imaging measurements with survival endpoints.
• Time to tumor progression [18 months]: Logistic regression model will be used to correlate imaging measurements with response status.
• 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.).

Sex: All, ages: 18 Years to any

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.

• Informed Consent Form (PDF, 2022-05-17)

• Priya Bhosale, Principal investigator, M.D. Anderson Cancer Center