An Investigational Scan (Magnetic Resonance Elastography) in Detecting Treatment Response in Patients With Advanced Liver Cancer
NCT ID: NCT04022746
Last Updated: 2025-02-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
6 participants
INTERVENTIONAL
2019-06-11
2025-02-13
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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Diagnostic (MRI/MRE)
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
Undergo multiparametric MRI/MRE
Magnetic Resonance Imaging
Undergo multiparametric MRI/MRE
Interventions
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Magnetic Resonance Elastography
Undergo multiparametric MRI/MRE
Magnetic Resonance Imaging
Undergo multiparametric MRI/MRE
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Inability to comply with study and/or follow-up procedures.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Priya Bhosale
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
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M D Anderson Cancer Center
Houston, Texas, United States
Countries
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Provided Documents
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Document Type: Informed Consent Form
Related Links
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University of Texas MD Anderson Cancer Center
Other Identifiers
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NCI-2019-02182
Identifier Type: REGISTRY
Identifier Source: secondary_id
2016-1113
Identifier Type: -
Identifier Source: org_study_id
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