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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a special MRI-based score, called the Muscle Assessment Score (MAsS), can predict risks after a liver transplant. The researchers seek to understand whether muscle composition affects patient outcomes following a liver transplant. They are recruiting individuals with serious liver disease who require a liver transplant and have an MRI planned as part of their evaluation. If an MRI is unsafe for a participant, this trial may not be suitable. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could enhance outcomes for future liver transplant patients.

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 prior data suggests that the MRI-based Muscle Assessment Score is safe for liver transplant candidates?

Research has shown that an MRI-based Muscle Assessment Score (MAsS) can be used for liver transplant patients. This method evaluates muscle size and fat content to determine if muscle composition can predict post-transplant outcomes. Although specific safety data for MAsS is not available, it is part of routine medical scans, indicating general safety. Additionally, this study does not test a new drug or involve invasive procedures, which typically reduces safety concerns. MAsS primarily involves MRI scans, which are non-invasive and widely used in healthcare. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Muscle Assessment Score (MAsS) because it offers a new way to identify liver transplant patients at risk for adverse outcomes. Unlike traditional methods that often rely on general pre-transplant health assessments, MAsS focuses specifically on muscle health as an indicator. This targeted approach could lead to more personalized patient care, potentially improving transplant success rates. By refining how risks are evaluated, MAsS has the potential to enhance decision-making processes in liver transplants, making it a promising development in the field.

What evidence suggests that the MRI-based Muscle Assessment Score is effective for assessing liver transplant outcomes?

Studies have shown that muscle mass can predict key outcomes after a liver transplant, such as the duration of intensive care unit stays and the number of days a patient requires a breathing tube. In this trial, the MRI-based Muscle Assessment Score (MAsS) will evaluate muscle quality and fat content, crucial for transplant evaluations. Research indicates that MAsS can identify transplant candidates at higher risk for complications. This score uses advanced imaging to offer a clear picture of muscle health, essential for predicting recovery success. Overall, better understanding muscle composition can improve liver transplant outcomes. ^{1 2 3 4 6}

Who Is on the Research Team?

Elizabet Carey, MD

Principal Investigator

Mayo Cinic

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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 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]

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 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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4382961/

Muscle Mass Predicts Outcomes Following Liver ...

Muscle mass predicted many important post-transplant outcomes including intensive care unit (ICU) and total length of stay and days of intubation.

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05477277

Adverse Outcomes and Mortality in Liver Transplant

The aim is to use an MRI-based Muscle Assessment Score (MAsS), which includes both muscle volume and fat infiltration, at the transplant candidacy evaluation ...

3.

withpower.com

withpower.com/trial/phase-liver-diseases-7-2022-2b6f9

Muscle Assessment Score 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 ...

4.

sciencedirect.com

sciencedirect.com/science/article/pii/S1365182X19305933

Assessment of magnetic resonance imaging derived fat ...

In their study muscle mass predicted many important post-transplant outcomes, including intensive care unit (ICU) stay, total length of stay (LOS), and days of ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11462649/

Body composition and muscle composition phenotypes in ...

MRI-based body composition profiling is feasible in LT patients and shortly after LT. This can be amended to routine clinical scans and may help in early ...

6.

mayo.edu

mayo.edu/research/clinical-trials/diseases-conditions/liver-disease

Liver Disease Clinical Trials

The primary aim of this study is to use an MRI-based Muscle Assessment Score (MAsS), which includes both muscle volume and fat infiltration, at the transplant ...