Clinical trial NCT04022746: An Investigational Scan (Magnetic Resonance Elastography) in Detecting Treatment Response in Patients With Advanced Liver Cancer
Official title: Multiparametric MRI and MRE Assessment of Liver Fibrosis in Patients Treated for HCC
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2019-07-17
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in magnetic resonance elastography (MRE) liver tumor stiffness
timeFrame: Baseline to 6 weeks
measure: Change in percent non-viable/necrotic tumor
timeFrame: Baseline to 6 weeks
Secondary outcomes:
measure: Overall survival
timeFrame: 18 months
measure: Time to tumor progression
timeFrame: 18 months
measure: Change in tumor size and enhancement
timeFrame: Baseline to 18 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Priya Bhosale
role: PRINCIPAL_INVESTIGATOR
References: