Muscle Assessment Score for Liver Transplant Outcomes

Overseen By Latasha Bunkley

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Mayo Clinic

Disqualifiers: Contraindication to MRI

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

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

Prospective natural history pilot study to explore the link between muscle composition using an MRI-based Muscle Assessment Score (MAsS) and adverse outcomes in liver transplant candidates.

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

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

What data supports the effectiveness of the treatment MAsS, MRI-based Muscle Assessment Score, for liver transplant outcomes?

Research shows that assessing muscle quality and abnormalities, like myosteatosis (fat in muscles), using imaging techniques like MRI can predict outcomes after liver transplantation. This suggests that the MRI-based Muscle Assessment Score (MAsS) could be effective in evaluating and potentially improving liver transplant outcomes by identifying patients at risk. ^{1 2 3 4 5}

Is the Muscle Assessment Score for Liver Transplant Outcomes safe for humans?

The research does not provide specific safety data for the Muscle Assessment Score itself, but it focuses on assessing muscle mass and its impact on liver transplant outcomes, which is generally a non-invasive and safe procedure. ^{1 2 3 4 6}

How does the Muscle Assessment Score treatment differ from other treatments for liver transplant outcomes?

The Muscle Assessment Score treatment is unique because it uses advanced imaging techniques like MRI and CT scans to evaluate muscle quality and fat content, which are important predictors of liver transplant outcomes. This approach focuses on assessing muscle health rather than just muscle mass, providing a more comprehensive understanding of a patient's condition before and after transplantation. ^{1 2 3 5 7}

Research Team

Elizabet Carey, MD

Principal Investigator

Mayo Cinic

Eligibility Criteria

This trial is for adults with end-stage liver disease who are being evaluated for a liver transplant and can safely undergo an MRI. It's not suitable for those who have conditions that make MRI scans unsafe for them.

Inclusion Criteria

I am being evaluated for a liver transplant due to end-stage liver disease.

I am 18 years old or older.

I need an MRI as part of my evaluation for a transplant.

Exclusion Criteria

You cannot have an MRI for medical reasons.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Transplant Candidacy Evaluation

MRI-based Muscle Assessment Score (MAsS) is used to evaluate muscle composition and identify high-risk candidates for liver transplant

Ongoing until transplant

Post-Transplant Monitoring

Participants are monitored for adverse outcomes and mortality within the first year after liver transplant

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

Treatment Details

Interventions

• MAsS

Trial Overview The study is looking at how muscle composition, measured by a special score from MRI images called MAsS, might predict complications or outcomes in people waiting for liver transplants.

Participant Groups

Group I: Define MAsS cut-point at transplant evaluation to identify those with high risk for adverse outcomes Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Amra Medical AB

Industry Sponsor

Trials

3

Recruited

260+

Findings from Research

A study of 180 liver transplant patients found that myosteatosis, measured by MRI-derived fat fraction, is associated with older age, higher likelihood of being female, and increased length of hospital stay.

Pre-transplant myosteatosis may predict worse outcomes after liver transplantation, including increased graft loss and mortality, highlighting the importance of assessing muscle fat content before surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of magnetic resonance imaging derived fat fraction as a sensitive and reliable predictor of myosteatosis in liver transplant recipients. Shenvi, SD., Taber, DJ., Hardie, AD., et al.[2021]

In a study of 97 liver transplant patients, those with sarcopenia (low muscle mass) had a significantly lower muscle mass index compared to those without sarcopenia, indicating that muscle mass is an important factor in preoperative assessments.

Sarcopenia was linked to a higher incidence of postoperative complications, suggesting that evaluating muscle mass using CT scans should be a routine part of the preoperative evaluation for liver transplant candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of Preoperative Muscle Mass Assessed by Computed Tomography on Prognosis After Liver Transplantation. Cabo, SN., León Díaz, FJ., Segura, JS., et al.[2020]

In a study of 107 liver transplantation patients, newly developed sarcopenia (ND-sarcopenia) identified through 3D muscle volume estimation on CT scans was linked to significantly poorer overall survival rates, with a hazard ratio of 3.34, indicating a threefold increase in risk.

Patients with ND-sarcopenia also experienced higher rates of post-transplant diabetes mellitus (PTDM), with a hazard ratio of 4.93, suggesting that monitoring muscle volume could be crucial for predicting complications and outcomes after liver transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Newly developed sarcopenia after liver transplantation, determined by a fully automated 3D muscle volume estimation on abdominal CT, can predict post-transplant diabetes mellitus and poor survival outcomes. Park, SJ., Yoon, JH., Joo, I., et al.[2023]

In a study of 88 high-acuity liver transplant recipients (MELD ≥35), those who experienced a significant decrease in skeletal muscle mass (ΔSMI < -5.0) had worse outcomes, including higher rates of early allograft dysfunction and lower patient and graft survival rates.

The findings suggest that monitoring and managing muscle mass changes perioperatively could be crucial for improving survival outcomes in liver transplant patients, highlighting the importance of rehabilitation efforts in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perioperative Skeletal Muscle Fluctuations in High-Acuity Liver Transplantation. Chong, J., Guorgui, J., Coy, H., et al.[2022]

In a study of 152 liver transplant patients, 61% were found to have sarcopenia before surgery, and both muscle mass and density decreased significantly in the short-term (11 months) and long-term (56 months) after transplantation.

The presence of myosteatosis (fatty infiltration of muscle) was linked to higher mortality rates post-transplant, indicating that muscle quality is a critical factor in predicting survival outcomes for liver transplant patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Muscle quality determined by computed tomography predicts short-term and long-term survival after liver transplantation. Molwitz, I., Recklies, F., Stark, M., et al.[2023]

In a study of 50 adults with end-stage liver disease in the ICU, serial ultrasound measurements of rectus femoris muscle area showed a significant and rapid decline in muscle mass, correlating with the length of ICU stay.

The decrease in muscle mass was linked to poor survival outcomes, indicating that monitoring muscle loss could be crucial for assessing the health of potential liver transplant candidates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of Serial Ultrasound Measurements of the Rectus Femoris Muscle Area to Assess Muscle Loss in Patients Awaiting Liver Transplantation in the Intensive Care Unit. Pita, A., Ziogas, IA., Ye, F., et al.[2022]

In a study of 353 patients with cirrhosis, skeletal muscle index (SMI) was found to be a more reliable predictor of mortality than psoas muscle index (PMI), particularly in men, indicating that SMI should be prioritized in clinical assessments.

Low PMI was associated with increased mortality risk but misclassified a significant number of patients (29%) compared to SMI, suggesting that relying solely on PMI could lead to underestimating the risk in patients with low muscle mass.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Poor performance of psoas muscle index for identification of patients with higher waitlist mortality risk in cirrhosis. Ebadi, M., Wang, CW., Lai, JC., et al.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Assessment of magnetic resonance imaging derived fat fraction as a sensitive and reliable predictor of myosteatosis in liver transplant recipients. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Influence of Preoperative Muscle Mass Assessed by Computed Tomography on Prognosis After Liver Transplantation. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Newly developed sarcopenia after liver transplantation, determined by a fully automated 3D muscle volume estimation on abdominal CT, can predict post-transplant diabetes mellitus and poor survival outcomes. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Perioperative Skeletal Muscle Fluctuations in High-Acuity Liver Transplantation. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Muscle quality determined by computed tomography predicts short-term and long-term survival after liver transplantation. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Feasibility of Serial Ultrasound Measurements of the Rectus Femoris Muscle Area to Assess Muscle Loss in Patients Awaiting Liver Transplantation in the Intensive Care Unit. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

Poor performance of psoas muscle index for identification of patients with higher waitlist mortality risk in cirrhosis. [2021]