Houston, Texas 77030


Purpose:

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.


Study summary:

PRIMARY OBJECTIVES: 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 60-90 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 until disease progression.


Criteria:

Inclusion Criteria: - Advanced liver cancer to be treated with systemic therapy with or without loco-regional ablation. - Available tumor and liver parenchyma tissue (biopsies available through Dr. Kaseb's Institutional Review Board (IRB) approved protocol: 2018-0516, 2018-0074, or 2017-0097; biopsies obtained within 5 [+/- 2] days of MRE). - Child-Pugh score A. - 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.


NCT ID:

NCT04022746


Primary Contact:

Principal Investigator
Aliya Qayyum
M.D. Anderson Cancer Center

Aliya Qayyum
Phone: 713-745-7245
Email: aqayyum@mdanderson.org


Backup Contact:

N/A


Location Contact:

Houston, Texas 77030
United States

Aliya Qayyum
Phone: 713-745-7245

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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