Magnetic Resonance Elastography for Liver Cancer

Overseen By Priya Bhosale

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

Disqualifiers: Pacemaker, Claustrophobia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how well a new scan, called magnetic resonance elastography (MRE), works alongside standard MRI imaging in tracking liver cancer's response to treatment. The focus is on liver cancer that has spread to other parts of the body. Individuals with biopsy-confirmed liver cancer who can undergo MRIs might be suitable candidates for this study. This could help doctors determine sooner and more clearly if a treatment is effective. As an unphased study, this trial offers a unique opportunity to contribute to innovative research that could enhance future cancer care.

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 prior data suggests that this investigational scan is safe for detecting liver cancer response?

Research has shown that magnetic resonance elastography (MRE) is a safe and noninvasive method to assess liver stiffness, aiding in the diagnosis of liver conditions such as fibrosis and cancer. Studies confirm MRE's high accuracy and lack of known risks when evaluating the liver.

A detailed review found MRE excels at detecting liver cancer, minimizing false positives. Another study demonstrated that MRE can evaluate liver function without surgery or needles, providing comfort for patients.

This trial focuses on using MRE to assess the effectiveness of liver cancer treatment. Previous studies emphasize MRE's safety, with no significant side effects reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Magnetic Resonance Elastography (MRE) for liver cancer is unique because it offers a non-invasive way to assess liver stiffness, which can be a key indicator of liver health and disease progression. Unlike traditional imaging methods, MRE combines MRI technology with low-frequency vibrations to create a detailed map of tissue stiffness. Researchers are excited about this technique because it could lead to earlier and more accurate detection of liver cancer changes, potentially improving treatment outcomes by allowing for more timely interventions. Additionally, it provides a way to monitor liver cancer progression and response to treatment without the need for invasive procedures like biopsies.

What evidence suggests that this investigational scan is effective for detecting treatment response in liver cancer?

Research has shown that magnetic resonance elastography (MRE), which participants in this trial will undergo, holds promise for detecting liver problems. A review of studies found that MRE accurately identifies liver cancer. It also effectively assesses liver function and proves more accurate and reliable than other methods. Studies highlight MRE's non-invasive nature, making it a safer choice for patients. Overall, MRE aids in understanding liver health, which is crucial for monitoring the effectiveness of liver cancer treatments. ^{1 2 4 6 7}

Who Is on the Research Team?

Priya R. Bhosale

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

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.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Diagnostic (MRI/MRE) Experimental Treatment 2 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.

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+

Published Research Related to This Trial

Magnetic resonance elastography (MRE) has been shown to have moderate sensitivity (64%) and high specificity (85%) in diagnosing hepatocellular carcinoma (HCC) based on a meta-analysis of 1,735 patients.

MRE can serve as an effective non-invasive diagnostic tool for HCC, aiding in clinical treatment decisions and prognostic assessments, despite its lower sensitivity compared to specificity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance elastography can predict the development of hepatocellular carcinoma: a meta-analysis and systematic review. Wu, L., Bi, J., Liu, L., et al.[2022]

Magnetic resonance elastography (MRE) is a noninvasive and highly accurate method for evaluating liver stiffness, with a low technical failure rate of only 5.8%, making it a reliable tool for diagnosing chronic liver disease.

MRE shows excellent correlation with liver biopsy, the gold standard for assessing liver fibrosis, and is increasingly being integrated into routine clinical practice for liver evaluations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Magnetic resonance elastography of the liver : Worth knowing for clinical routine]. Plaikner, M., Kremser, C., Viveiros, A., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Liver stiffness measured by MR elastography is a predictor of early HCC recurrence after treatment. Cho, HJ., Kim, B., Kim, HJ., et al.[2021]

Magnetic resonance elastography (MRE) is a highly accurate noninvasive method for assessing liver stiffness, making it a promising alternative to liver biopsy for detecting and staging liver fibrosis.

MRE demonstrates excellent reproducibility and interobserver agreement, meaning that it can be reliably used across different patients and by different healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance elastography of liver. Venkatesh, SK., Ehman, RL.[2021]

In a study of 293 patients, 3D MR elastography (MRE) demonstrated significantly better image quality and higher interobserver agreement in measuring liver stiffness compared to 2D MRE.

Both 2D and 3D MRE showed similar diagnostic performance for staging liver fibrosis, outperforming blood-based biomarkers, particularly for more advanced fibrosis stages.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the diagnostic performance of 2D and 3D MR elastography in staging liver fibrosis. Li, M., Yang, H., Liu, Y., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunotherapy response evaluation with magnetic resonance elastography (MRE) in advanced HCC. Qayyum, A., Hwang, KP., Stafford, J., et al.[2020]

Magnetic resonance elastography (MRE) using spin-echo echo planar imaging (SE-EPI) provides comparable liver stiffness measurements to gradient-recalled echo (GRE) methods, with a strong correlation (r = 0.96) between the two sequences in a study of liver imaging.

SE-EPI is more reliable than GRE, as it had no unmeasurable cases, while GRE had 2.5% unmeasurable cases, particularly in patients with high R2* values, suggesting SE-EPI is preferable for accurate liver stiffness assessment.

NCBI (Pubmed)

pubmed.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. Abe, R., Fukuzawa, K., Yoshihara, C., et al.[2023]

MR elastography (MRE) effectively differentiates between malignant and benign liver tumors, showing that malignant tumors have a significantly higher mean shear stiffness (10.1 kPa) compared to benign tumors (2.7 kPa) and normal liver tissue (2.3 kPa).

A stiffness cutoff value of 5 kPa was identified as a reliable marker for distinguishing malignant tumors from benign tumors and normal liver, highlighting MRE's potential as a noninvasive diagnostic tool for liver tumor characterization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MR elastography of liver tumors: preliminary results. Venkatesh, SK., Yin, M., Glockner, JF., et al.[2021]

Magnetic resonance elastography (MRE) is significantly more accurate than diffusion-weighted imaging (DWI) in differentiating between benign and malignant focal liver lesions (FLLs), with an accuracy of 98.6% compared to 82%.

In the study of 79 subjects with 124 FLLs, malignant lesions exhibited higher stiffness (7.9 kPa) and lower apparent diffusion coefficient (ADC) values (129 × 10(-3) mm²/s) compared to benign lesions, indicating that MRE can effectively identify the nature of liver lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of magnetic resonance elastography and diffusion-weighted imaging for differentiating benign and malignant liver lesions. Hennedige, TP., Hallinan, JT., Leung, FP., et al.[2022]

In a study of 102 patients undergoing liver-directed radiation therapy, elevated liver stiffness (LS) greater than 3.0 kPa was found to significantly increase the risk of developing radiation-induced liver disease (RILD), with a hazard ratio of 4.9.

Both pre-treatment LS and the mean liver dose during radiation therapy were identified as significant risk factors for RILD, highlighting the importance of assessing liver stiffness before treatment to predict potential complications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of Pretreatment Magnetic Resonance Elastography for the Prediction of Radiation-Induced Liver Disease. Mullikin, TC., Pepin, KM., Evans, JE., et al.[2022]

Magnetic resonance elastography (MRE) was successfully performed on 85 patients using a 3T MRI, demonstrating its effectiveness in identifying and staging liver fibrosis non-invasively.

The study found a strong correlation between MRE results and histopathology in 46 patients, with MRE accurately identifying fibrosis stages in 44 of them, highlighting its reliability as a diagnostic tool.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary experience with 3T magnetic resonance elastography imaging of the liver. Joshi, A., Muthe, MM., Firke, V., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8421890/

a meta-analysis and systematic review - PMC - PubMed Central The results of our meta-analysis show that MRE has moderate sensitivity and excellent specificity in the detection of HCC. MRE can be an effective diagnostic ...

2. jgo.amegroups.org jgo.amegroups.org/article/view/55100/html

Magnetic resonance elastography can predict the ... The results of our meta-analysis show that MRE has moderate sensitivity and excellent specificity in the detection of HCC.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4481448/

Use of magnetic resonance elastography for assessing ... CONCLUSION: MRE is accurate and non-invasive; furthermore, it can be used to effectively assess the liver functional reserve of HCC patients. Keywords: Magnetic ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S1665268122002319

Clinical application of Magnetic resonance elastography in ... In addition, MRE has been shown to have higher diagnostic accuracy and better reproducibility than other elastographic modalities in staging hepatic fibrosis [ ...

5. gastrojournal.org gastrojournal.org/article/S0016-5085(22)00735-1/fulltext

Liver Stiffness on Magnetic Resonance Elastography and ... ... MRE has a strong association with liver-related outcomes, hepatocellular carcinoma, and death. The 3-year risk of the composite outcome of ...

6. pubs.rsna.org pubs.rsna.org/doi/full/10.1148/radiol.231220

Interpretation, Reporting, and Clinical Applications of Liver ... MR elastography (MRE) is considered the most accurate noninvasive technique for diagnosing and staging liver fibrosis.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0730725X24000699

Magnetic resonance elastography as a preoperative ... Magnetic resonance elastography (MRE) is a noninvasive tool for diagnosing hepatic fibrosis with high accuracy. We investigated the preoperative clinical and ...