NCT04022746

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2019

Completed
5.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2025

Completed
Last Updated

February 19, 2025

Status Verified

February 1, 2025

Enrollment Period

5.7 years

First QC Date

July 15, 2019

Last Update Submit

February 17, 2025

Conditions

Advanced Adult Hepatocellular CarcinomaStage III Hepatocellular Carcinoma AJCC v8Stage IIIA Hepatocellular Carcinoma AJCC v8Stage IIIB Hepatocellular Carcinoma AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Stage IVA Hepatocellular Carcinoma AJCC v8Stage IVB Hepatocellular Carcinoma AJCC v8

Outcome Measures

Primary Outcomes (2)

  • Change in magnetic resonance elastography (MRE) liver tumor stiffness

    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.

    Baseline to 6 weeks

  • Change in percent non-viable/necrotic tumor

    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.

    Baseline to 6 weeks

Secondary Outcomes (3)

  • Overall survival

    18 months

  • Time to tumor progression

    18 months

  • Change in tumor size and enhancement

    Baseline to 18 months

Study Arms (1)

Diagnostic (MRI/MRE)

EXPERIMENTAL

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.

Procedure: Magnetic Resonance ElastographyProcedure: Magnetic Resonance Imaging

Interventions

Magnetic Resonance ElastographyPROCEDURE

Undergo multiparametric MRI/MRE

Also known as: MRE
Diagnostic (MRI/MRE)
Magnetic Resonance ImagingPROCEDURE

Undergo multiparametric MRI/MRE

Also known as: Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR Imaging, MRI, MRI Scan, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging
Diagnostic (MRI/MRE)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Priya Bhosale

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2019

First Posted

July 17, 2019

Study Start

June 11, 2019

Primary Completion

February 13, 2025

Study Completion

February 13, 2025

Last Updated

February 19, 2025

Record last verified: 2025-02

Locations

US(1)