Multiparametric MRI and MRE Assessment of Liver Fibrosis in Patients Treated for HCC
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 6
- Locations
- 2
- Primary Endpoint
- Change in magnetic resonance elastography (MRE) liver tumor stiffness
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Time Frame: 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
Time Frame: 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)
- Change in tumor size and enhancement(Baseline to 18 months)
- Time to tumor progression(18 months)