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

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ClinicalTrials.gov Identifier: NCT04022746

Recruitment Status : Recruiting

First Posted : July 17, 2019

Last Update Posted : July 17, 2019

See Contacts and Locations

Sponsor:

Collaborator:

National Cancer Institute (NCI)

Information provided by (Responsible Party):

M.D. Anderson Cancer Center

Tracking Information

First Submitted Date ^ICMJE

July 15, 2019

First Posted Date ^ICMJE

July 17, 2019

Last Update Posted Date

July 17, 2019

Actual Study Start Date ^ICMJE

June 11, 2019

Estimated Primary Completion Date

December 15, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

No Changes Posted

Current Secondary Outcome Measures ^ICMJE

Overall survival [ Time Frame: 18 months ]
Cox proportional hazard model will be used to correlate imaging measurements with survival endpoints.
Time to tumor progression [ Time Frame: 18 months ]
Logistic regression model will be used to correlate imaging measurements with response status.
Change in tumor size and enhancement [ Time Frame: Baseline to 18 months ]
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.).

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 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.

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Condition ^ICMJE

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

Intervention ^ICMJE

Procedure: Magnetic Resonance Elastography
Undergo multiparametric MRI/MRE

Other Name: MRE
Procedure: Magnetic Resonance Imaging
Undergo multiparametric MRI/MRE
Other Names:
- Magnetic Resonance Imaging Scan
- Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
- MRI
- MRI Scan
- NMR Imaging
- NMRI
- Nuclear Magnetic Resonance Imaging

Study Arms ^ICMJE

Experimental: Diagnostic (MRI/MRE)

Interventions:

Procedure: Magnetic Resonance Elastography
Procedure: Magnetic Resonance Imaging

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date ^ICMJE

December 15, 2022

Estimated Primary Completion Date

December 15, 2022 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact: Aliya Qayyum

713-745-7245

aqayyum@mdanderson.org

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT04022746

Other Study ID Numbers ^ICMJE

2016-1113
NCI-2019-02182 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
2016-1113 ( Other Identifier: M D Anderson Cancer Center )
P30CA016672 ( U.S. NIH Grant/Contract )

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

IPD Sharing Statement ^ICMJE

Not Provided

Responsible Party

M.D. Anderson Cancer Center

Study Sponsor ^ICMJE

M.D. Anderson Cancer Center

Collaborators ^ICMJE

National Cancer Institute (NCI)

Investigators ^ICMJE

Principal Investigator:

Aliya Qayyum

M.D. Anderson Cancer Center

PRS Account

M.D. Anderson Cancer Center

Verification Date

July 2019

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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