ClinicalTrials.Veeva

Menu

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

M.D. Anderson Cancer Center logo

M.D. Anderson Cancer Center

Status

Enrolling

Conditions

Stage IIIA Hepatocellular Carcinoma AJCC V8
Advanced Adult Hepatocellular Carcinoma
Stage IIIB Hepatocellular Carcinoma AJCC V8
Stage IV Hepatocellular Carcinoma AJCC V8
Stage IVA Hepatocellular Carcinoma AJCC V8
Stage III Hepatocellular Carcinoma AJCC V8
Stage IVB Hepatocellular Carcinoma AJCC V8

Treatments

Procedure: Magnetic Resonance Elastography
Procedure: Magnetic Resonance Imaging

Study type

Interventional

Funder types

Other
NIH

Identifiers

NCT04022746
2016-1113 (Other Identifier)
NCI-2019-02182 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Diagnostic

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

50 participants in 1 patient group

Diagnostic (MRI/MRE)
Experimental group
Description:
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.
Treatment:
Procedure: Magnetic Resonance Imaging
Procedure: Magnetic Resonance Elastography

Trial contacts and locations

1

Loading...

Central trial contact

Priya Bhosale

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems