6 Participants Needed

Magnetic Resonance Elastography for Liver Cancer

PB
Overseen ByPriya Bhosale
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: M.D. Anderson Cancer Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications.

What data supports the idea that Magnetic Resonance Elastography for Liver Cancer is an effective treatment?

The available research shows that Magnetic Resonance Elastography (MRE) is useful in predicting the early return of liver cancer after treatment by measuring liver stiffness. This can help doctors decide on the best treatment plan. Additionally, MRE can help evaluate how well patients with advanced liver cancer respond to immunotherapy, a type of treatment that uses the body's immune system to fight cancer. While MRE is not a treatment itself, it supports other treatments by providing important information about the liver's condition and the effectiveness of ongoing therapies.12345

What safety data exists for Magnetic Resonance Elastography (MRE) in liver cancer treatment?

The available research indicates that Magnetic Resonance Elastography (MRE) is a non-invasive and safe technique for assessing liver stiffness and fibrosis. It is described as having excellent reproducibility, repeatability, and interobserver agreement, making it a reliable method for liver evaluation. MRE is applicable to almost all patients and body types, and it is considered the most accurate non-invasive technique for detecting and staging liver fibrosis, with the potential to replace liver biopsy. No specific safety concerns are highlighted in the provided studies, suggesting that MRE is generally considered safe for use in liver cancer assessment.678910

Is Magnetic Resonance Elastography a promising treatment for liver cancer?

Yes, Magnetic Resonance Elastography (MRE) is a promising treatment for liver cancer. It is a non-invasive method that helps doctors measure how stiff the liver is, which can be important for detecting liver problems early. MRE can also help predict if liver cancer might come back after treatment, making it a valuable tool for managing liver health.1671112

What is the purpose of this trial?

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.

Research Team

Priya Bhosale | MD Anderson Cancer Center

Priya R. Bhosale

Principal Investigator

M.D. Anderson Cancer Center

Eligibility Criteria

This trial is for patients with advanced liver cancer that has spread, who have biopsy-proven hepatocellular carcinoma (HCC) and can provide tissue samples. Participants must not have any conditions that make MRI unsafe, like metal implants or fragments in the body, and cannot be pregnant. They must also be able to give informed consent.

Inclusion Criteria

Not pregnant
No contraindications to MRI (such as implanted ferromagnetic or pump devices, metallic fragments in eye), as indicated on our departmental MRI screening form
I have liver cancer.
See 2 more

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week
1 visit (in-person)

Baseline Assessment

Patients undergo standard of care MRI and MRE within 5 days of liver biopsy before receiving any medical treatment for HCC

1 week
1 visit (in-person)

Initial Treatment Assessment

MRE and MRI are performed to assess changes in liver tumor stiffness and necrosis after 6 weeks of treatment

6 weeks
1 visit (in-person)

Ongoing Monitoring

Patients undergo MRI and MRE every 12 weeks to monitor treatment response and tumor progression

24 months
8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

18 months

Treatment Details

Interventions

  • Investigational Scan
  • Standard Imaging
Trial Overview The study is testing a new type of scan called Magnetic Resonance Elastography (MRE), alongside standard MRI scans, to see if they can better detect how well treatments are working in patients with advanced liver cancer.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Diagnostic (MRI/MRE)Experimental Treatment2 Interventions
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials
3,107
Recruited
1,813,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

In a study of 192 hepatocellular carcinoma (HCC) patients, liver stiffness measured by magnetic resonance elastography (MRE) was found to be an independent predictor of early tumor recurrence after treatment, with higher stiffness correlating to increased risk.
Specifically, liver stiffness greater than 5.5 kPa was associated with worse recurrence-free survival, suggesting that patients with high stiffness may require closer monitoring after treatment.
Liver stiffness measured by MR elastography is a predictor of early HCC recurrence after treatment.Cho, HJ., Kim, B., Kim, HJ., et al.[2021]
The study validated the use of 3T spin-echo echo-planar imaging (SE-EPI) magnetic resonance elastography (MRE) for staging hepatic fibrosis in a large cohort of 310 adults, showing excellent inter-reader reproducibility (ICC of 0.98).
The diagnostic performance for staging fibrosis was high, with cutoff values for diagnosing significant fibrosis (≥ F2, ≥ F3, and F4) showing sensitivity between 91.2% and 95.9% and specificity between 90.7% and 99.0%, indicating that MRE is a reliable non-invasive method for assessing liver stiffness.
Diagnostic Performance of Spin-Echo Echo-Planar Imaging Magnetic Resonance Elastography in 3T System for Noninvasive Assessment of Hepatic Fibrosis.Kim, SW., Lee, JM., Park, S., et al.[2022]
In a study of 15 patients with advanced hepatocellular carcinoma (HCC) treated with Pembrolizumab, changes in tumor stiffness measured by magnetic resonance elastography (MRE) at 6 weeks were strongly correlated with overall survival (OS) and time to disease progression (TTP), suggesting it may be a predictor of immunotherapy response.
The study found that an increase in intratumoral CD3+ T lymphocytes also correlated with changes in tumor stiffness, indicating that immune response may be linked to the mechanical properties of the tumor.
Immunotherapy response evaluation with magnetic resonance elastography (MRE) in advanced HCC.Qayyum, A., Hwang, KP., Stafford, J., et al.[2020]

References

Liver stiffness measured by MR elastography is a predictor of early HCC recurrence after treatment. [2021]
Diagnostic Performance of Spin-Echo Echo-Planar Imaging Magnetic Resonance Elastography in 3T System for Noninvasive Assessment of Hepatic Fibrosis. [2022]
Immunotherapy response evaluation with magnetic resonance elastography (MRE) in advanced HCC. [2020]
MR elastography of liver tumors: preliminary results. [2021]
Comparison of magnetic resonance elastography and diffusion-weighted imaging for differentiating benign and malignant liver lesions. [2022]
Preliminary experience with 3T magnetic resonance elastography imaging of the liver. [2022]
Evaluation of Pretreatment Magnetic Resonance Elastography for the Prediction of Radiation-Induced Liver Disease. [2022]
Magnetic resonance elastography can predict the development of hepatocellular carcinoma: a meta-analysis and systematic review. [2022]
Magnetic resonance elastography of liver. [2021]
Comparison of the diagnostic performance of 2D and 3D MR elastography in staging liver fibrosis. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
Comparison of spin-echo echo planar imaging and gradient-recalled echo sequences in magnetic resonance elastography of liver at 1.5T same MRI scanner. [2023]
[Magnetic resonance elastography of the liver : Worth knowing for clinical routine]. [2022]
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