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

Advanced Adult Hepatocellular Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04022746
• Other study ID #: 2016-1113
• Secondary ID: NCI-2019-02182
• Status: Recruiting
• Phase: N/A
• Start date: June 11, 2019
• Est. completion date: April 30, 2025

Study information

• Verified date: April 2024
• Source: M.D. Anderson Cancer Center
• Contact: Priya Bhosale
• Phone: 713-792-0221
• Email: priya.bhosale[@]mdanderson.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2025
• Est. primary completion date: April 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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.

Related Conditions & MeSH terms

• Advanced Adult Hepatocellular Carcinoma
• Carcinoma
• Carcinoma, Hepatocellular
• 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

Procedure:
• Magnetic Resonance Elastography
Undergo multiparametric MRI/MRE
• Magnetic Resonance Imaging
Undergo multiparametric MRI/MRE

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Overall survival	Cox proportional hazard model will be used to correlate imaging measurements with survival endpoints.	18 months
Secondary	Time to tumor progression	Logistic regression model will be used to correlate imaging measurements with response status.	18 months
Secondary	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

External Links

•   University of Texas MD Anderson Cancer Center